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Protocol summary
The aim of this randomized clinical trial is to investigating Assessing the Compare the effect of purslane cream and lanolin to sore nipples in referring to health centers affiliated to Mashhad University of Medical Sciences in2016. In this study, women suffering from nipple fissure and nipple pain who exclusively breast fed ; have healthy term infants; normal infant weight and without any mouth or palate or jaw or face anomaly; mother without any nipple malformation are entered to this study. Excluding criteria include the infant usage of a pacifier or feeding bottle; the infant gets infected to a disease; the mother makes use of milking machine or plastic nipple; the mother gets infected to mastitis, breast abscesses or fungal infection of the breast and use of the proposed treatment less thanThree times a day. 80 sample will be assigned randomly into two groups:applying purslane cream or control group (lanolin). In the intervention group mothers apply an amount of purslane cream on nipple and Areola after feeding Three times a day for 7 days. Mothers in control group apply lanolin on nipple and areola after each feeding for 7 days . At the begining two groups will receive correct feeding technique. Store and Numerical Rating Scale is completed before the study, on day 3 and on day8 after the study by the investigator to evaluate nipple fissure intensity.
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The aim of this randomized clinical trial is to investigating Assessing the Compare the effect of purslane cream and lanolin to sore nipples in referring to health centers affiliated to Mashhad University of Medical Sciences in2016. In this study, women suffering from nipple fissure and nipple pain who exclusively breast fed ; have healthy term infants; normal infant weight and without any mouth or palate or jaw or face anomaly; mother without any nipple malformation are entered to this study. Excluding criteria include the infant usage of a pacifier or feeding bottle; the infant gets infected to a disease; the mother makes use of milking machine or plastic nipple; the mother gets infected to mastitis, breast abscesses or fungal infection of the breast and use of the proposed treatment less thanThree times a day. 80 sample will be assigned randomly into two groups:applying purslane cream or control group (lanolin). In the intervention group mothers apply an amount of purslane cream on nipple and Areola after feeding Three times a day for 7 days. Mothers in control group apply lanolin on nipple and areola after each feeding for 7 days . At the begining two groups will receive correct feeding technique. Store and Numerical Rating Scale is completed before the study, on day 3 and on day8 after the study by the investigator to evaluate nipple fissure intensity.
هدف از این کارآزمایی بالینی تصادفی شده بررسی مقایسه ای اثرکرم خرفه ولانولین بر شقاق نوک پستان در مراجعین به مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی مشهد سال 1395می باشد. در این مطالعه زنان شیرده مبتلا به شقاق و درد نوک پستان دارای تغذیه انحصاری با شیر مادر، دارای نوزاد ترم و سالم، با وزن طبیعی و عدم ابتلای نوزاد به ناهنجاري در دهان، کام، فک و صورت، عدم ابتلای مادر به ناهنجاری های نوک پستان وارد مطالعه می شوند. معیارهای خروج شامل استفاده نوزاد از پستانک یا شیشه شیر،ابتلای نوزاد به بیماری، استفاده مادر از شیردوش یا نوک پستان پلاستیکی، ابتلای مادربه ماستيت، آبسه يا عفونت قارچي پستان و استفاده کمتر از روزی3بار از درمان می باشد. 80نمونه به صورت تخصیص تصادفی به گروه مداخله(کرم خرفه) و گروه کنترل( لانولین) تقسیم خواهند شد. در گروه مداخله مادران کرم خرفه را روزی 3بار به مدت 7 روز بعد از شیردهی بر روی نوک پستان و هاله اطراف استعمال می کنند. مادران گروه کنترل نیز به مدت 7 روز بعد از هر بار شیردهی لانولین را روی نوک پستان و هاله اطراف می مالند . در ابتدا به دو گروه آموزش تکنیک صحیح شیردهی داده می شود.قبل از مطالعه، روز سوم و روز هشتم پس از شروع مطالعه مقیاس استور، و خط کش درد جهت سنجش شقاق نوک پستان توسط پژوهشگر تکمیل می شود.
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هدف از این کارآزمایی بالینی تصادفی شده بررسی مقایسه ای اثرکرم خرفه ولانولین بر شقاق نوک پستان در مراجعین به مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی مشهد سال 1395می باشد. در این مطالعه زنان شیرده مبتلا به شقاق و درد نوک پستان دارای تغذیه انحصاری با شیر مادر، دارای نوزاد ترم و سالم، با وزن طبیعی و عدم ابتلای نوزاد به ناهنجاري در دهان، کام، فک و صورت، عدم ابتلای مادر به ناهنجاری های نوک پستان وارد مطالعه می شوند. معیارهای خروج شامل استفاده نوزاد از پستانک یا شیشه شیر،ابتلای نوزاد به بیماری، استفاده مادر از شیردوش یا نوک پستان پلاستیکی، ابتلای مادربه ماستيت، آبسه يا عفونت قارچي پستان و استفاده کمتر از روزی3بار از درمان می باشد. 80نمونه به صورت تخصیص تصادفی به گروه مداخله(کرم خرفه) و گروه کنترل( لانولین) تقسیم خواهند شد. در گروه مداخله مادران کرم خرفه را روزی 3بار به مدت 7 روز بعد از شیردهی بر روی نوک پستان و هاله اطراف استعمال می کنند. مادران گروه کنترل نیز به مدت 7 روز بعد از هر بار شیردهی لانولین را روی نوک پستان و هاله اطراف می مالند . در ابتدا به دو گروه آموزش تکنیک صحیح شیردهی داده می شود.قبل از مطالعه، روز سوم و روز هشتم پس از شروع مطالعه مقیاس استور، و خط کش درد جهت سنجش شقاق نوک پستان توسط پژوهشگر تکمیل می شود.
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effects of purslane on the nipple fissure
effects of purslane on the nipple fissure
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تعیین اثر کرم خرفه بر شقاق نوک پستان
تعیین اثر کرم خرفه بر شقاق نوک پستان
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A randomized, controlled, double-blind, placebo-controlled clinical trial
A randomized, controlled, double-blind, placebo-controlled clinical trial
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کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، دو سویه کور ، تصادفی شده
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This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week.
This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week.
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این مطالعه در مراکز بهداشتی شهر مشهد انجام شد. افراد به صورت تصادفی در دو گروه کرم خرفه و لانولین قرار گرفتند و به مدت یک هفته روزی سه بار از درمان استفاده نمودند. داروساز داروهارو در بسته بندی مشابه و یکسان قرار داد به طوری که محقق و واحدهای پژوهش از نوع درمان بی اطلاع بودند.
این مطالعه در مراکز بهداشتی شهر مشهد انجام شد. افراد به صورت تصادفی در دو گروه کرم خرفه و لانولین قرار گرفتند و به مدت یک هفته روزی سه بار از درمان استفاده نمودند. داروساز داروهارو در بسته بندی مشابه و یکسان قرار داد به طوری که محقق و واحدهای پژوهش از نوع درمان بی اطلاع بودند.
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The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day,
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day,
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تابعیت ایرانی ، مقیم مشهد ، داشتن حاملگی تک قلو و ترم ، امکان برقراری تماس تلفنی ، داشتن حداقل سواد خواندن و نوشتن
معیارهای خروج از مطالعه شامل: ناهنجاری های نوک سینه مادر ، بیماریهای روانی و قلبی عروقی شناخته شده در مادر است. علاوه بر این ، سایر معیارهای خروج از مطالعه شامل آبسه و عفونت پستان در مادر ، استفاده از پستانک ، شیشه شیر و نوک سینه پلاستیک ، بیماری نوزاد ، ابتلای نوزاد به قارچ دهان حین مطالعه ، ابتلای مادر به بیماری های عفونی ، حساسیت به کرم خرفه و لانولین بود. عدم انجام ویزیت در روزهای مطالعه به هر علتی، استفاده مادر از درمانهای دیگری مانند مالیدن شیر یا آنتی بیوتیک در مدت زمان انجام مطالعه، عدم استفاده از درمان توصیه شده برای یک روز یا کمتر از روزی 3 بار ، استفاده از کمپرس گرم و سرد، تغذیه انحصاری نوزاد با شیرمادر ، کسب نمره حداقل 2 از مقیاس استور
تابعیت ایرانی ، مقیم مشهد ، داشتن حاملگی تک قلو و ترم ، امکان برقراری تماس تلفنی ، داشتن حداقل سواد خواندن و نوشتن معیارهای خروج از مطالعه شامل: ناهنجاری های نوک سینه مادر ، بیماریهای روانی و قلبی عروقی شناخته شده در مادر است. علاوه بر این ، سایر معیارهای خروج از مطالعه شامل آبسه و عفونت پستان در مادر ، استفاده از پستانک ، شیشه شیر و نوک سینه پلاستیک ، بیماری نوزاد ، ابتلای نوزاد به قارچ دهان حین مطالعه ، ابتلای مادر به بیماری های عفونی ، حساسیت به کرم خرفه و لانولین بود. عدم انجام ویزیت در روزهای مطالعه به هر علتی، استفاده مادر از درمانهای دیگری مانند مالیدن شیر یا آنتی بیوتیک در مدت زمان انجام مطالعه، عدم استفاده از درمان توصیه شده برای یک روز یا کمتر از روزی 3 بار ، استفاده از کمپرس گرم و سرد، تغذیه انحصاری نوزاد با شیرمادر ، کسب نمره حداقل 2 از مقیاس استور
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in groups purslane and lanolin use it on the nipple as amount of a finger, three times a day
immediately after breastfeeding, to cover the entire thin layer of the fissure and continue
treatment up to seven days.
in groups purslane and lanolin use it on the nipple as amount of a finger, three times a day immediately after breastfeeding, to cover the entire thin layer of the fissure and continue treatment up to seven days.
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در گروه کرم خرفه و لانولین بعد ازشيردهي به نوک پستان و هاله اطراف آن به میزان 1گرم ، روزی 3 بار به مدت 7 روز ماليده شد.در گروه کنترل لانولین بعد ازشيردهي به نوک پستان و هاله اطراف آن به میزان 1گرم ، روزی 3 بار به مدت 7 روز ماليده شد.
در گروه کرم خرفه و لانولین بعد ازشيردهي به نوک پستان و هاله اطراف آن به میزان 1گرم ، روزی 3 بار به مدت 7 روز ماليده شد.در گروه کنترل لانولین بعد ازشيردهي به نوک پستان و هاله اطراف آن به میزان 1گرم ، روزی 3 بار به مدت 7 روز ماليده شد.
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This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week. The pharmacist put the drug in the same and similar package so that the researcher and the research unit were unaware of the type of treatment.
This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week. The pharmacist put the drug in the same and similar package so that the researcher and the research unit were unaware of the type of treatment.
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شقاق نوک پستان، درد نوک پستان
شقاق نوک پستان، درد نوک پستان
General information
1
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1
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80
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80
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2016-10-08, 1395/07/17
2016-10-08 00:00:00
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2016-12-26, 1395/10/06
2016-12-26 00:00:00
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2017-11-11, 1396/08/20
2017-11-11 00:00:00
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Edit study information according to who criteria
Edit study information according to who criteria
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ویرایش اطلاعات مطالعه بر اساس معیارهای who
ویرایش اطلاعات مطالعه بر اساس معیارهای who
Comparing the effect of Purslane Cream and Lanolin to Sore Nipple
تعریف‌های crack
صفت
damaged and showing lines on the surface from having split without coming apart.
the old pipes were cracked and leaking
مترادف‌ها: chipped, broken, crazed, fractured, splintered, shattered, split, damaged, defective, flawed, imperfect
crazy; insane.
you must think my family is cracked
فعل
break or cause to break without a complete separation of the parts.
the ice all over the lake had cracked
مترادف‌ها: break
Purslane Cream on the Breast Fissure
Comparing the effect of Purslane Cream and Lanolin to Sore Nipple تعریف‌های crack صفت damaged and showing lines on the surface from having split without coming apart. the old pipes were cracked and leaking مترادف‌ها: chipped, broken, crazed, fractured, splintered, shattered, split, damaged, defective, flawed, imperfect crazy; insane. you must think my family is cracked فعل break or cause to break without a complete separation of the parts. the ice all over the lake had cracked مترادف‌ها: breakBreast Fissure
مقایسه اثر کرم خرفه و لانولین برشقاق نوک پستان
کرم خرفه در شقاق نوک پستان
مقایسه اثر کرم خرفه و لانولین برشقاقدر شقاق نوک پستان
Comparing the effect of Purslane Cream and Lanolin to Sore Nipple Feeding women
effects of Purslane Cream on the BreastFissure in Lactating Women: A Clinical Trial
Comparing the effecteffects of Purslane Cream and Lanolin to Sore Nipple Feeding womenon the BreastFissure in Lactating Women: A Clinical Trial
مقایسه اثرکرم خرفه ولانولین بر شقاق نوک پستان زنان شیرده
تاثیرکرم خرفه بر شقاق نوک پستان زنان شیرده: یک کارآزمایی بالینی
مقایسه اثرکرمتاثیرکرم خرفه ولانولین بر شقاق نوک پستان زنان شیرده: یک کارآزمایی بالینی
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.
معیار ورود به مطالعه شامل: تابعیت ایرانی ، مقیم مشهد ، داشتن حاملگی تک قلو و ترم ، امکان برقراری تماس تلفنی ، داشتن حداقل سواد خواندن و نوشتن ، تغذیه انحصاری نوزاد با شیرمادر ، کسب نمره حداقل 2 از مقیاس استور
معیار ورود به مطالعه شامل: تابعیت ایرانی ، مقیم مشهد ، داشتن حاملگی تک قلو و ترم ، امکان برقراری تماس تلفنی ، داشتن حداقل سواد خواندن و نوشتن ، تغذیه انحصاری نوزاد با شیرمادر ، کسب نمره حداقل 2 از مقیاس استور
Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. Moreover, other exclusion criteria were abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day, and mother's use ofcold or hot compresses
Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. Moreover, other exclusion criteria were abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day, and mother's use ofcold or hot compresses
معیارهای خروج از مطالعه شامل: ناهنجاری های نوک سینه مادر ، بیماریهای روانی و قلبی عروقی شناخته شده در مادر است. علاوه بر این ، سایر معیارهای خروج از مطالعه شامل آبسه و عفونت پستان در مادر ، استفاده از پستانک ، شیشه شیر و نوک سینه پلاستیک ، بیماری نوزاد ، ابتلای نوزاد به قارچ دهان حین مطالعه ، ابتلای مادر به بیماری های عفونی ، حساسیت به کرم خرفه و لانولین بود. عدم انجام ویزیت در روزهای مطالعه به هر علتی، استفاده مادر از درمانهای دیگری مانند مالیدن شیر یا آنتی بیوتیک در مدت زمان انجام مطالعه، عدم استفاده از درمان توصیه شده برای یک روز یا کمتر از روزی 3 بار ، استفاده از کمپرس گرم و سرد
معیارهای خروج از مطالعه شامل: ناهنجاری های نوک سینه مادر ، بیماریهای روانی و قلبی عروقی شناخته شده در مادر است. علاوه بر این ، سایر معیارهای خروج از مطالعه شامل آبسه و عفونت پستان در مادر ، استفاده از پستانک ، شیشه شیر و نوک سینه پلاستیک ، بیماری نوزاد ، ابتلای نوزاد به قارچ دهان حین مطالعه ، ابتلای مادر به بیماری های عفونی ، حساسیت به کرم خرفه و لانولین بود. عدم انجام ویزیت در روزهای مطالعه به هر علتی، استفاده مادر از درمانهای دیگری مانند مالیدن شیر یا آنتی بیوتیک در مدت زمان انجام مطالعه، عدم استفاده از درمان توصیه شده برای یک روز یا کمتر از روزی 3 بار ، استفاده از کمپرس گرم و سرد
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In the present study, multi-stage sampling was performed. In the first stage, sampling was done
in a class. The classes are the five regions of health centers (1-5) of Mashhad, Iran. They were
randomly selected from two classes (center number 3 and 5). The second phase of sampling
was randomly carried out according to the ratio of the patients referred to the thyroid clinic of
centers 3 and 5. In the third stage, among the lactating women referring to these 4 thyroid clinic
centers, firstly, the units of study were selected by inclusion criteria and then placed in two
groups of lanolin and purslane creams on the basis of random numbers. Noteworthy, mothers
along with their children should be routinely visited by their health centers on the third to fifth
day after childbirth to screen and prevent the hypothyroidism and related disorders. In this
regard, these centers were selected to provide more access to lactating women during this
period. Following the selection, required explanations regarding the research design, the
method of research, how to use drugs and the probability of drug allergy were given to them. If
they wished to participate in the research, written consent was obtained in order to observe the
ethical issues, they were assured about the confidentiality of their information and they can
leave the study at any time desired. Using the number cruncher statistical system (NCSS)
software, the samples were randomly assigned to one of the two groups of lanolin and purslane
cream
In the present study, multi-stage sampling was performed. In the first stage, sampling was done in a class. The classes are the five regions of health centers (1-5) of Mashhad, Iran. They were randomly selected from two classes (center number 3 and 5). The second phase of sampling was randomly carried out according to the ratio of the patients referred to the thyroid clinic of centers 3 and 5. In the third stage, among the lactating women referring to these 4 thyroid clinic centers, firstly, the units of study were selected by inclusion criteria and then placed in two groups of lanolin and purslane creams on the basis of random numbers. Noteworthy, mothers along with their children should be routinely visited by their health centers on the third to fifth day after childbirth to screen and prevent the hypothyroidism and related disorders. In this regard, these centers were selected to provide more access to lactating women during this period. Following the selection, required explanations regarding the research design, the method of research, how to use drugs and the probability of drug allergy were given to them. If they wished to participate in the research, written consent was obtained in order to observe the ethical issues, they were assured about the confidentiality of their information and they can leave the study at any time desired. Using the number cruncher statistical system (NCSS) software, the samples were randomly assigned to one of the two groups of lanolin and purslane cream
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نمونه گیری به صورت چند مرحله ای انجام شد. ابتدا به طور تصادفی از مراکز بهداشتی 5 گانه شهر مشهد، دو مرکز انتخاب شدند. سپس متناسب با حجم مراجعین به واحد کم کاری تیروئید، از مراکز بهداشتی درمانی شماره 3 و 5 هر یک دو مرکز به طور تصادفی انتخاب شدند. در مرحله سوم واحدهای پژوهش به صورت در دسترس از میان زنان شیردهی که در روز سوم و پنجم پس از زایمان برای انجام آزمایش غربالگری کم کاری تیروئید نوزاد خود به مراکز بهداشتی درمانی منتخب مراجعه کرده بودند، انتخاب شدند و توضیحات لازم در ارتباط با طرح تحقیق، روش انجام پژوهش، نحوه استفاده از دارو و احتمال بروز حساسیت دارویی به آنها داده شد. در صورت تمایل به شرکت در پژوهش رضایت نامه کتبی از ایشان اخذ گردید و به آنها اطمینان داده شد که اطلاعات آنها محرمانه خواهد ماند و هر زمان که بخواهند می توانند از مطالعه خارج شوند. افراد بر اساس نرم افزار (NCSS)به صورت تصادفی در دو گروه کرم خرفه و لانولین قرار گرفتند.
نمونه گیری به صورت چند مرحله ای انجام شد. ابتدا به طور تصادفی از مراکز بهداشتی 5 گانه شهر مشهد، دو مرکز انتخاب شدند. سپس متناسب با حجم مراجعین به واحد کم کاری تیروئید، از مراکز بهداشتی درمانی شماره 3 و 5 هر یک دو مرکز به طور تصادفی انتخاب شدند. در مرحله سوم واحدهای پژوهش به صورت در دسترس از میان زنان شیردهی که در روز سوم و پنجم پس از زایمان برای انجام آزمایش غربالگری کم کاری تیروئید نوزاد خود به مراکز بهداشتی درمانی منتخب مراجعه کرده بودند، انتخاب شدند و توضیحات لازم در ارتباط با طرح تحقیق، روش انجام پژوهش، نحوه استفاده از دارو و احتمال بروز حساسیت دارویی به آنها داده شد. در صورت تمایل به شرکت در پژوهش رضایت نامه کتبی از ایشان اخذ گردید و به آنها اطمینان داده شد که اطلاعات آنها محرمانه خواهد ماند و هر زمان که بخواهند می توانند از مطالعه خارج شوند. افراد بر اساس نرم افزار (NCSS)به صورت تصادفی در دو گروه کرم خرفه و لانولین قرار گرفتند.
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Drugs were packed by the pharmacist who un-known regarding the process of the study, in the
same tubes of 30 grams and was coded (A and B).
Drugs were packed by the pharmacist who un-known regarding the process of the study, in the same tubes of 30 grams and was coded (A and B).
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داروها توسط داروساز در قوطی های 30 گرمی یکسان و یک شکل بسته بندی و کد گذاری(Aو B) شد.
داروها توسط داروساز در قوطی های 30 گرمی یکسان و یک شکل بسته بندی و کد گذاری(Aو B) شد.
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Primary outcomes
#1
Reduction of nipple pain
Breast Fissure
Reduction of nipple painBreast Fissure
کاهش درد پستان
شقاق نوک پستان
کاهش دردشقاق نوک پستان
Using Numerical Rating Scale for measuring pain intensity
Using Stour scale
Using Numerical Rating Scale for measuring pain intensityStour scale
اندازه گیری شدت درد بر اساس مقیاس عددی درد
استفاده از مقیاس استور
اندازه گیری شدت درد بر اساساستفاده از مقیاس عددی درداستور
Recruitment centers
#1
Name of recruitment center - English: Health Centers In Mashhad
Name of recruitment center - Persian: مراکز بهداشتی درمانی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: آذین نیازی
Street address - English:
Street address - Persian:
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Health Centers In Mashhad
Name of recruitment center - Persian: مراکز بهداشتی درمانی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: آذین نیازی
Street address - English: The Doctor's Way
Street address - Persian: 4 راه دکتری
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6818714818
Phone: +98 51 3859 1511
Fax:
Email: azin_niazi65@yahoo.com
Web page address:
Name of recruitment center - English: Health Centers In Mashhad Name of recruitment center - Persian: مراکز بهداشتی درمانی مشهد Full name of responsible person - English: Azin Niazi Full name of responsible person - Persian: آذین نیازی Street address - English: The Doctor's Way Street address - Persian: 4 راه دکتری City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 6818714818 Phone: +98 51 3859 1511 Fax: Email: azin_niazi65@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهش وفناوری دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaqodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Mashhad، Ghoreshi Building , Daneshgah street
Street address - Persian: مشهد، خیابان دانشگاه، ساختمان قریشی
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهش وفناوری دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaqodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Mashhad، Ghoreshi Building , Daneshgah street
Street address - Persian: مشهد، خیابان دانشگاه، ساختمان قریشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 6818714818
Phone: +98 51 3859 1511
Fax:
Email: azin_niazi65@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for Research and Technology Mashhad University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهش وفناوری دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Mohsen Tafaqodi Full name of responsible person - Persian: محسن تفقدی Street address - English: Mashhad، Ghoreshi Building , Daneshgah street Street address - Persian: مشهد، خیابان دانشگاه، ساختمان قریشی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 6818714818 Phone: +98 51 3859 1511 Fax: Email: azin_niazi65@yahoo.com Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: اذین نیازی
Position - English: Master of Science University Student of Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing And Midwifery
Street address - Persian: دانشکده پرستاری ومامایی
City - English: mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3859 1511
Mobile: 00
Fax:
Email: niazia931@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: اذین نیازی
Position - English: Master of Science University Student of Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مامایی
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing And Midwifery
Street address - Persian: دانشکده پرستاری ومامایی
City - English: mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6818714818
Phone: +98 51 3859 1511
Mobile: +98 919 919 1800
Fax:
Email: niazia931@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Azin Niazi Full name of responsible person - Persian: اذین نیازی Position - English: Master of Science University Student of Midwifery Position - Persian: دانشجوی کارشناسی ارشد مامایی Latest degree: bachelor Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing And Midwifery Street address - Persian: دانشکده پرستاری ومامایی City - English: mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6818714818 Phone: +98 51 3859 1511 Mobile: 00+98 919 919 1800 Fax: Email: niazia931@mums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Mashhad Univercity of Medical Sciences
Name of organization / entity - Persian: دانشکده علوم پزشکی مشهد
Full name of responsible person - English: Sedighe Yousefzade
Full name of responsible person - Persian: صدیقه یوسف زاده
Position - English: Academic Faculty Member
Position - Persian: هیات علمی-فوق لیسانس
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fourway Doctoral Faculty، of Nursing and Midwifery
Street address - Persian: چهار راه دکتری، دانشکده پرستاری ومامایی
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3859 1511
Mobile: 00
Fax:
Email: sedighe yousefzade@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad Univercity of Medical Sciences
Name of organization / entity - Persian: دانشکده علوم پزشکی مشهد
Full name of responsible person - English: Sedighe Yousefzade
Full name of responsible person - Persian: صدیقه یوسف زاده
Position - English: Academic Faculty Member
Position - Persian: هیات علمی-فوق لیسانس
Latest degree: master
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fourway Doctoral Faculty، of Nursing and Midwifery
Street address - Persian: چهار راه دکتری، دانشکده پرستاری ومامایی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6818714818
Phone: +98 51 3859 1511
Mobile: +98 910 919 1800
Fax:
Email: yousefzadehs@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad Univercity of Medical Sciences Name of organization / entity - Persian: دانشکده علوم پزشکی مشهد Full name of responsible person - English: Sedighe Yousefzade Full name of responsible person - Persian: صدیقه یوسف زاده Position - English: Academic Faculty Member Position - Persian: هیات علمی-فوق لیسانس Latest degree: master Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fourway Doctoral Faculty، of Nursing and Midwifery Street address - Persian: چهار راه دکتری، دانشکده پرستاری ومامایی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6818714818 Phone: +98 51 3859 1511 Mobile: 00+98 910 919 1800 Fax: Email: sedighe yousefzadeyousefzadehs@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Mashhad Univercity of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: اذین نیازی
Position - English: Master of Science University Student of Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery
Street address - Persian: دانشکده پرستاری ومامایی
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3859 1511
Mobile: 00
Fax:
Email: niazia931@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad Univercity of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Azin Niazi
Full name of responsible person - Persian: اذین نیازی
Position - English: Master of Science University Student of Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مامایی
Latest degree: master
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery
Street address - Persian: دانشکده پرستاری ومامایی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6818714818
Phone: +98 51 3859 1511
Mobile: +98 910 919 1800
Fax:
Email: niazia931@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad Univercity of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Azin Niazi Full name of responsible person - Persian: اذین نیازی Position - English: Master of Science University Student of Midwifery Position - Persian: دانشجوی کارشناسی ارشد مامایی Latest degree: master Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery Street address - Persian: دانشکده پرستاری ومامایی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6818714818 Phone: +98 51 3859 1511 Mobile: 00+98 910 919 1800 Fax: Email: niazia931@mums.ac.ir Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
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Promising effects of Purslane Cream on the Breast Fissure in
Lactating Women: A Clinical Trial
Promising effects of Purslane Cream on the Breast Fissure in Lactating Women: A Clinical Trial
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تاثیر کرم خرفه بر شقاق نوک پستان: یک کارآزمایی بالینی
تاثیر کرم خرفه بر شقاق نوک پستان: یک کارآزمایی بالینی
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2018
2018
empty
1397
1397
empty
student midwife
student midwife
empty
دانشجویان مامایی
دانشجویان مامایی
empty
systematic review
systematic review
empty
مرور سیستماتیک
مرور سیستماتیک
empty
azin_niazi65@yahoo.com
azin_niazi65@yahoo.com
empty
از طریق ایمیل
از طریق ایمیل
empty
Articles published in this field will be sent to the applicant.
Articles published in this field will be sent to the applicant.
empty
مقالات انتشار یافته در این زمینه برای متقاضی ارسال خواهد شد.
مقالات انتشار یافته در این زمینه برای متقاضی ارسال خواهد شد.
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Protocol summary
Study aim
effects of purslane on the nipple fissure
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week.
Participants/Inclusion and exclusion criteria
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day,
Intervention groups
in groups purslane and lanolin use it on the nipple as amount of a finger, three times a day
immediately after breastfeeding, to cover the entire thin layer of the fissure and continue
treatment up to seven days.
Main outcome variables
This study was performed in health centers of Mashhad. Subjects were randomly assigned into two groups of purslane and lanolin cream and received treatment three times a week. The pharmacist put the drug in the same and similar package so that the researcher and the research unit were unaware of the type of treatment.
General information
Reason for update
Edit study information according to who criteria
Acronym
IRCT registration information
IRCT registration number:IRCT2015042421915N1
Registration date:2017-01-28, 1395/11/09
Registration timing:retrospective
Last update:2019-10-16, 1398/07/24
Update count:1
Registration date
2017-01-28, 1395/11/09
Registrant information
Name
Azin Niazi
Name of organization / entity
Mashhad Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 9914
Email address
azin_niazi65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Mashhad University of Mdical Sciences
Expected recruitment start date
2016-10-08, 1395/07/17
Expected recruitment end date
2016-12-26, 1395/10/06
Actual recruitment start date
2016-10-08, 1395/07/17
Actual recruitment end date
2016-12-26, 1395/10/06
Trial completion date
2017-11-11, 1396/08/20
Scientific title
effects of Purslane Cream on the BreastFissure in Lactating Women: A Clinical Trial
Public title
Purslane Cream on the Breast Fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria were Iranian nationality, the resident of Mashhad, single and termpregnancy, the possibility for a phone call, being literate, exclusive breastfeeding, obtainingthe score of at least 2 from the Store scale.
Exclusion criteria:
Exclusion CriteriaThe exclusion criteria included maternal nipple abnormalities , known psychological and cardiovascular diseases in mother. Moreover, other exclusion criteria were abscess an infection of breast in the mother, use of pacifier, milk glass and plastic breast nipple, infant's disease, infant's infection to oral mucosa during the study, mother's infection to infectious diseases, sensitivity to purslane cream and lanolin during use, lack of visits at determined days for anyreason, the mother's use of other treatments such as using milk, or antibiotics during the studyperiod, not using the treatment for one day or less than three times a day, and mother's use ofcold or hot compresses
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
86
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, multi-stage sampling was performed. In the first stage, sampling was done
in a class. The classes are the five regions of health centers (1-5) of Mashhad, Iran. They were
randomly selected from two classes (center number 3 and 5). The second phase of sampling
was randomly carried out according to the ratio of the patients referred to the thyroid clinic of
centers 3 and 5. In the third stage, among the lactating women referring to these 4 thyroid clinic
centers, firstly, the units of study were selected by inclusion criteria and then placed in two
groups of lanolin and purslane creams on the basis of random numbers. Noteworthy, mothers
along with their children should be routinely visited by their health centers on the third to fifth
day after childbirth to screen and prevent the hypothyroidism and related disorders. In this
regard, these centers were selected to provide more access to lactating women during this
period. Following the selection, required explanations regarding the research design, the
method of research, how to use drugs and the probability of drug allergy were given to them. If
they wished to participate in the research, written consent was obtained in order to observe the
ethical issues, they were assured about the confidentiality of their information and they can
leave the study at any time desired. Using the number cruncher statistical system (NCSS)
software, the samples were randomly assigned to one of the two groups of lanolin and purslane
cream
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs were packed by the pharmacist who un-known regarding the process of the study, in the
same tubes of 30 grams and was coded (A and B).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research of Mashhad University of medical sciences
Street address
Mashhad ، Ghoreshi Building ، Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
6818714818
Approval date
2016-09-18, 1395/06/28
Ethics committee reference number
IR.MUMS.REC.1395.300
Health conditions studied
1
Description of health condition studied
Nipple fissure
ICD-10 code
N64.0
ICD-10 code description
Fissure and fistula of nipple
Primary outcomes
1
Description
Breast Fissure
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Using Stour scale
Secondary outcomes
1
Description
The improvement of nipple fissures
Timepoint
Before intervention, day 3 and day 8 after intervention
Method of measurement
Measure the severity of damage, by store
Intervention groups
1
Description
In the intervention group after breastfeeding 1gr purslane cream will be rubbed to the nipple and areola 3 times a day for8 days.control group after breastfeeding 1grlanolin cream will be rubbed to the nipple and areola 3 times a day for8 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers In Mashhad
Full name of responsible person
Azin Niazi
Street address
The Doctor's Way
City
Mashhad
Province
Razavi Khorasan
Postal code
6818714818
Phone
+98 51 3859 1511
Email
azin_niazi65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
Mashhad، Ghoreshi Building , Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
6818714818
Phone
+98 51 3859 1511
Email
azin_niazi65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azin Niazi
Position
Master of Science University Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing And Midwifery
City
mashhad
Province
Razavi Khorasan
Postal code
6818714818
Phone
+98 51 3859 1511
Fax
Email
niazia931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Univercity of Medical Sciences
Full name of responsible person
Sedighe Yousefzade
Position
Academic Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Fourway Doctoral Faculty، of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
6818714818
Phone
+98 51 3859 1511
Fax
Email
yousefzadehs@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Univercity of Medical Sciences
Full name of responsible person
Azin Niazi
Position
Master of Science University Student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
6818714818
Phone
+98 51 3859 1511
Fax
Email
niazia931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Promising effects of Purslane Cream on the Breast Fissure in
Lactating Women: A Clinical Trial
When the data will become available and for how long
2018
To whom data/document is available
student midwife
Under which criteria data/document could be used
systematic review
From where data/document is obtainable
azin_niazi65@yahoo.com
What processes are involved for a request to access data/document
Articles published in this field will be sent to the applicant.