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Protocol summary
Objectives: To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women.
Study design: clinical trial.
Setting and conduct: 90 pregnant women who refere to health centers of Mashhad will be randomly assigned to three groups of continuous care model, telehealth and control. Each health center will be assigned to one of these three groups listed.
Main conditions for participants to enterance to or exiting from the study : Women aged 35-45;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
Intervention: For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks).
Main outcome variables: Sleep quality in pregnant women
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Objectives: To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women. Study design: clinical trial. Setting and conduct: 90 pregnant women who refere to health centers of Mashhad will be randomly assigned to three groups of continuous care model, telehealth and control. Each health center will be assigned to one of these three groups listed. Main conditions for participants to enterance to or exiting from the study : Women aged 35-45;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI). Intervention: For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks). Main outcome variables: Sleep quality in pregnant women
مطالعه با هدف: مقایسه تاثیر آموزش مبتنی بر مدل مراقبت پیگیر و مراقبت از راه دور (تله هلث) برکیفیت خواب زنان باردار انجام خواهد شد.
طراحی مطالعه: اين پژوهش از نوع کارآزمایی بالینی خواهد بود.
روش انجام: به این صورت که 90 نفر از زنان باردار مراجعه کننده به مراکز بهداشتی درمانی شهر مشهد، به روش تخصیص تصادفی به سه گروه مراقبت پیگیر،تله هلث و کنترل تقسیم خواهند شد. به این ترتیب که هر مرکز بهداشت به یکی از سه گروه ذکر شده اختصاص خواهد یافت.
شرایط ورود و خروج اصلی شرکت کنندگان شامل: زنان 35-18 سال؛ حاملگی تک قلو با سن حاملگی 16-20 هفته و کسب نمره 5 یا بالاتر در پرسشنامه کیفیت خواب پیتزبورگ(PSQI) می باشد.
مداخلات: برای گروه مداخله مراقبت پیگیر، ابتدا یک جلسه آشنایی برگزار میگردد (آشناسازی)، سپس 4 جلسه آموزشی طی 4 هفته، برگزار میگردد و ارتباط با خانواده وی از طریق تلفن و کتابچه آموزشی برقرار میگردد(حساس سازی). سپس، طی سه هفته، هرهفته یک تماس تلفنی10 دقیقه ای برقرار خواهد شد (کنترل) و در نهایت، کیفیت خواب، بلافاصله و 4 هفته بعد(مجموعا 12 هفته) بررسی خواهد شد (ارزشیابی). در گروه تله هلث، ابتدا یک جلسه آشناسازی برگزار میگردد، سپس 4 سی دی کد گذاری شده در اختیار مادران قرار داده میشود و توصیه میشود هر هفته یک سی دی را مشاهده نمایند، طی این 4 هفته و 4 هفته پس از آن ( 8 هفته)، مشاوره تلفنی به مدت 15-10 دقیقه (یکبار در هفته) انجام میگیرد و کیفیت خواب بلافاصله و 4 هفته بعد از مداخله( مجموعا 12 هفته) ارزیابی خواهد شد .
متغیر های پیامد اصلی: کیفیت خواب زنان باردار
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مطالعه با هدف: مقایسه تاثیر آموزش مبتنی بر مدل مراقبت پیگیر و مراقبت از راه دور (تله هلث) برکیفیت خواب زنان باردار انجام خواهد شد. طراحی مطالعه: اين پژوهش از نوع کارآزمایی بالینی خواهد بود. روش انجام: به این صورت که 90 نفر از زنان باردار مراجعه کننده به مراکز بهداشتی درمانی شهر مشهد، به روش تخصیص تصادفی به سه گروه مراقبت پیگیر،تله هلث و کنترل تقسیم خواهند شد. به این ترتیب که هر مرکز بهداشت به یکی از سه گروه ذکر شده اختصاص خواهد یافت. شرایط ورود و خروج اصلی شرکت کنندگان شامل: زنان 35-18 سال؛ حاملگی تک قلو با سن حاملگی 16-20 هفته و کسب نمره 5 یا بالاتر در پرسشنامه کیفیت خواب پیتزبورگ(PSQI) می باشد. مداخلات: برای گروه مداخله مراقبت پیگیر، ابتدا یک جلسه آشنایی برگزار میگردد (آشناسازی)، سپس 4 جلسه آموزشی طی 4 هفته، برگزار میگردد و ارتباط با خانواده وی از طریق تلفن و کتابچه آموزشی برقرار میگردد(حساس سازی). سپس، طی سه هفته، هرهفته یک تماس تلفنی10 دقیقه ای برقرار خواهد شد (کنترل) و در نهایت، کیفیت خواب، بلافاصله و 4 هفته بعد(مجموعا 12 هفته) بررسی خواهد شد (ارزشیابی). در گروه تله هلث، ابتدا یک جلسه آشناسازی برگزار میگردد، سپس 4 سی دی کد گذاری شده در اختیار مادران قرار داده میشود و توصیه میشود هر هفته یک سی دی را مشاهده نمایند، طی این 4 هفته و 4 هفته پس از آن ( 8 هفته)، مشاوره تلفنی به مدت 15-10 دقیقه (یکبار در هفته) انجام میگیرد و کیفیت خواب بلافاصله و 4 هفته بعد از مداخله( مجموعا 12 هفته) ارزیابی خواهد شد . متغیر های پیامد اصلی: کیفیت خواب زنان باردار
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To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women
To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women
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مقایسه تاثیر آموزش مبتنی بر مدل مراقبت پیگیر و مراقبت از راه دور (تله هلث) برکیفیت خواب زنان باردار
مقایسه تاثیر آموزش مبتنی بر مدل مراقبت پیگیر و مراقبت از راه دور (تله هلث) برکیفیت خواب زنان باردار
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Three groups of clinical trials with a control group, community based and pragmatic, parallel groups,no blind, randomized.
Three groups of clinical trials with a control group, community based and pragmatic, parallel groups,no blind, randomized.
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کارآزمایی بالینی سه گروهه دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، گروه های موازی، کور نشده، تصادفی شده.
کارآزمایی بالینی سه گروهه دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، گروه های موازی، کور نشده، تصادفی شده.
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This randomized, three-group study was performed in Mashhad's health centers.
After confirmation of the research by the Ethics Committee of Mashhad University of Medical Sciences and expressing the goals of studying and satisfying the pregnant women and obtaining written consent from them, and taking into account ethical codes, the sample was selected and carried out.
This randomized, three-group study was performed in Mashhad's health centers. After confirmation of the research by the Ethics Committee of Mashhad University of Medical Sciences and expressing the goals of studying and satisfying the pregnant women and obtaining written consent from them, and taking into account ethical codes, the sample was selected and carried out.
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این مطالعه تصادفی شده، سه گروهه، در مراکز بهداشتی و درمانی شهر مشهد انجام شده است.
پس از تائید پژوهش توسط کمیته اخلاق دانشگاه علوم پزشکی مشهد و بیان اهداف مطالعه و جلب رضایت زنان باردار و گرفتن رضایت نامه کتبی از آنها و با در نظر گرفتن کدهای اخلاقی، اقدام به نمونه گیری و انجام پژوهش شد.
این مطالعه تصادفی شده، سه گروهه، در مراکز بهداشتی و درمانی شهر مشهد انجام شده است. پس از تائید پژوهش توسط کمیته اخلاق دانشگاه علوم پزشکی مشهد و بیان اهداف مطالعه و جلب رضایت زنان باردار و گرفتن رضایت نامه کتبی از آنها و با در نظر گرفتن کدهای اخلاقی، اقدام به نمونه گیری و انجام پژوهش شد.
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Women aged 35-18;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
Women aged 35-18;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
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زنان 35-18 سال؛ حاملگی تک قلو با سن حاملگی 16-20 هفته و کسب نمره 5 یا بالاتر در پرسشنامه کیفیت خواب پیتزبورگ(PSQI) می باشد
زنان 35-18 سال؛ حاملگی تک قلو با سن حاملگی 16-20 هفته و کسب نمره 5 یا بالاتر در پرسشنامه کیفیت خواب پیتزبورگ(PSQI) می باشد
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For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks). For the control group, the usual care was taken by the health centers.
For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks). For the control group, the usual care was taken by the health centers.
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برای گروه مداخله مراقبت پیگیر، ابتدا یک جلسه آشنایی برگزار میگردد (آشناسازی)، سپس 4 جلسه آموزشی طی 4 هفته، برگزار میگردد و ارتباط با خانواده وی از طریق تلفن و کتابچه آموزشی برقرار میگردد(حساس سازی). سپس، طی سه هفته، هرهفته یک تماس تلفنی10 دقیقه ای برقرار خواهد شد (کنترل) و در نهایت، کیفیت خواب، بلافاصله و 4 هفته بعد(مجموعا 12 هفته) بررسی خواهد شد (ارزشیابی). در گروه تله هلث، ابتدا یک جلسه آشناسازی برگزار میگردد، سپس 4 سی دی کد گذاری شده در اختیار مادران قرار داده میشود و توصیه میشود هر هفته یک سی دی را مشاهده نمایند، طی این 4 هفته و 4 هفته پس از آن ( 8 هفته)، مشاوره تلفنی به مدت 15-10 دقیقه (یکبار در هفته) انجام میگیرد و کیفیت خواب بلافاصله و 4 هفته بعد از مداخله( مجموعا 12 هفته) ارزیابی خواهد شد. برای گروه کنترل، مراقبت های معمول مراکز بهداشت انجام خواد شد.
برای گروه مداخله مراقبت پیگیر، ابتدا یک جلسه آشنایی برگزار میگردد (آشناسازی)، سپس 4 جلسه آموزشی طی 4 هفته، برگزار میگردد و ارتباط با خانواده وی از طریق تلفن و کتابچه آموزشی برقرار میگردد(حساس سازی). سپس، طی سه هفته، هرهفته یک تماس تلفنی10 دقیقه ای برقرار خواهد شد (کنترل) و در نهایت، کیفیت خواب، بلافاصله و 4 هفته بعد(مجموعا 12 هفته) بررسی خواهد شد (ارزشیابی). در گروه تله هلث، ابتدا یک جلسه آشناسازی برگزار میگردد، سپس 4 سی دی کد گذاری شده در اختیار مادران قرار داده میشود و توصیه میشود هر هفته یک سی دی را مشاهده نمایند، طی این 4 هفته و 4 هفته پس از آن ( 8 هفته)، مشاوره تلفنی به مدت 15-10 دقیقه (یکبار در هفته) انجام میگیرد و کیفیت خواب بلافاصله و 4 هفته بعد از مداخله( مجموعا 12 هفته) ارزیابی خواهد شد. برای گروه کنترل، مراقبت های معمول مراکز بهداشت انجام خواد شد.
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Sleep quality in pregnant women
Sleep quality in pregnant women
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کیفیت خواب زنان باردار
کیفیت خواب زنان باردار
General information
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2017-12-22, 1396/10/01
2018-02-19, 1396/11/30
20172018-1202-2219 00:00:00
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2017-07-23, 1396/05/01
2017-07-23 00:00:00
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2018-02-19, 1396/11/30
2018-02-19 00:00:00
have Spontaneous written consent
Being Iranian and resident of Mashhad
The gestational age is between 16 and 20 weeks
Pregnancies with one fetus
Mother`s age between 18 to 35
The least literacy of mother and her husband be about fifth grade elementary school
In response to the Pittsburgh Sleep Quality Questionnaire, she earns 5 scores and more
In response to the restless leg assessment Questionnaire, she earns 3-0 scores
In response to STOP Questionnaire , she earns 2-0 scores
In response to question 1, the intensity of ISI Questionnaire , she earns 0-5 scores
In response to stress , anxiety and depression Questionnaire less than 10, 14, and 17 scores were obtained from depression, anxiety and stress levels;
Having fixed or mobile phone numbers
have Spontaneous written consent Being Iranian and resident of Mashhad The gestational age is between 16 and 20 weeks Pregnancies with one fetus Mother`s age between 18 to 35 The least literacy of mother and her husband be about fifth grade elementary school In response to the Pittsburgh Sleep Quality Questionnaire, she earns 5 scores and more In response to the restless leg assessment Questionnaire, she earns 3-0 scores In response to STOP Questionnaire , she earns 2-0 scores In response to question 1, the intensity of ISI Questionnaire , she earns 0-5 scores In response to stress , anxiety and depression Questionnaire less than 10, 14, and 17 scores were obtained from depression, anxiety and stress levels; Having fixed or mobile phone numbers
رضایت آگاهانه کتبی داشته باشد
ایرانی و ساکن مشهد باشد
سن حاملگی بین16 تا 20 هفته باشد
حاملگی تک قلو باشد
سن مادر بین 18 تا 35 سال باشد
مادر و همسرش حداقل سواد پنجم دبستان را داشته باشند
در پاسخ به پرسشنامه کیفیت خواب پیتزبورگ نمره 5 و بالاتر کسب کند
در پاسخ به پرسشنامه ارزیابی پای بیقرار نمره بین 3-0 را کسب کند
در پاسخ به پرسشنامه آپنه انسدای خواب نمره بین 2-0 را کسب کند
در پاسخ به سوال 1 از پرسشنامه شدت بیخوابی نمره بین 5-0 را کسب کند
در پاسخ به پرسشنامه استرس، اضطراب، افسردگی نمره کمتر از 10، 14، 17 به ترتیب از بعد افسردگی، اضطراب و استرس را کسب کند
شماره تلفن ثابت و یا همراه داشته باشد
رضایت آگاهانه کتبی داشته باشد ایرانی و ساکن مشهد باشد سن حاملگی بین16 تا 20 هفته باشد حاملگی تک قلو باشد سن مادر بین 18 تا 35 سال باشد مادر و همسرش حداقل سواد پنجم دبستان را داشته باشند در پاسخ به پرسشنامه کیفیت خواب پیتزبورگ نمره 5 و بالاتر کسب کند در پاسخ به پرسشنامه ارزیابی پای بیقرار نمره بین 3-0 را کسب کند در پاسخ به پرسشنامه آپنه انسدای خواب نمره بین 2-0 را کسب کند در پاسخ به سوال 1 از پرسشنامه شدت بیخوابی نمره بین 5-0 را کسب کند در پاسخ به پرسشنامه استرس، اضطراب، افسردگی نمره کمتر از 10، 14، 17 به ترتیب از بعد افسردگی، اضطراب و استرس را کسب کند شماره تلفن ثابت و یا همراه داشته باشد
linguistic, audio or dialectal problems
Having sleep disorders history before pregnancy
A bad important event has been occured from three months before the commencement of the study
Having medical disease
Having mental illness
Having midwifery problems
Having history of infertility and the current pregnancy does be a result of infertility treatment
Pre-pregnancy BMI does be equal to or greater than 30
Having addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband
During the research she does have night shift work
linguistic, audio or dialectal problems Having sleep disorders history before pregnancy A bad important event has been occured from three months before the commencement of the study Having medical disease Having mental illness Having midwifery problems Having history of infertility and the current pregnancy does be a result of infertility treatment Pre-pregnancy BMI does be equal to or greater than 30 Having addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband During the research she does have night shift work
مشکلات گفتاری، شنیداری یا لهجه ای داشته باشد
سابقه اختلالات خواب در قبل از بارداری را داشته باشد
حادثه مهم و ناگوار در طی سه ماه قبل از شروع مطالعه رخ داده باشد
بیماری طبی داشته باشد
بیماری روحی و روانی داشته باشد
مشکلات مامایی داشته باشد
سابقه ناباروری داشته باشد و یا بارداری فعلی در نتیجه درمان ناباروری باشد
شاخص توده بدنی قبل از بارداری، مساوی و یا بیشتر از 30 باشد
به انواع دخانیات( قلیان، سیگار، چپق، مواد مخدر) یا الکل و داروهای روان گردان، واحد پژوهش و یا همسرش، اعتیاد داشته باشد
طی پژوهش شیفت کار شبانه داشته باشد
مشکلات گفتاری، شنیداری یا لهجه ای داشته باشد سابقه اختلالات خواب در قبل از بارداری را داشته باشد حادثه مهم و ناگوار در طی سه ماه قبل از شروع مطالعه رخ داده باشد بیماری طبی داشته باشد بیماری روحی و روانی داشته باشد مشکلات مامایی داشته باشد سابقه ناباروری داشته باشد و یا بارداری فعلی در نتیجه درمان ناباروری باشد شاخص توده بدنی قبل از بارداری، مساوی و یا بیشتر از 30 باشد به انواع دخانیات( قلیان، سیگار، چپق، مواد مخدر) یا الکل و داروهای روان گردان، واحد پژوهش و یا همسرش، اعتیاد داشته باشد طی پژوهش شیفت کار شبانه داشته باشد
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The name of the center has been used to randomize the lottery method.
Lottery in the name of health centers has been done to locate each group in each health facility.
The name of the center has been used to randomize the lottery method. Lottery in the name of health centers has been done to locate each group in each health facility.
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جهت تصادفی سازی از روش قرعه کشی نام مرکز استفاده شده است.
قرعه کشی در نام مراکز بهداشتی به جهت قرار گیری هر گروه در هر مرکز بهداشتی انجام شده است.
جهت تصادفی سازی از روش قرعه کشی نام مرکز استفاده شده است. قرعه کشی در نام مراکز بهداشتی به جهت قرار گیری هر گروه در هر مرکز بهداشتی انجام شده است.
Recruitment centers
#1
Name of recruitment center - English: Iesargaran health center
Name of recruitment center - Persian: مرکز بهداشت ایثارگران
Full name of responsible person - English: Dr. Tabibzadeh
Full name of responsible person - Persian: دکتر طبیب زاده
Street address - English: Hedayat 1, Hedayat Blvd
Street address - Persian: بلوار هدایت نبش هدایت 1
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: Iesargaran health center
Name of recruitment center - Persian: مرکز بهداشت ایثارگران
Full name of responsible person - English: Dr. Tabibzadeh
Full name of responsible person - Persian: دکتر طبیب زاده
Street address - English: Hedayat 1, Hedayat Blvd
Street address - Persian: بلوار هدایت نبش هدایت 1
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 51 3733 9855
Fax:
Email: behdasht3@mums.ac.ir
Web page address:
Name of recruitment center - English: Iesargaran health center Name of recruitment center - Persian: مرکز بهداشت ایثارگران Full name of responsible person - English: Dr. Tabibzadeh Full name of responsible person - Persian: دکتر طبیب زاده Street address - English: Hedayat 1, Hedayat Blvd Street address - Persian: بلوار هدایت نبش هدایت 1 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 51 3733 9855 Fax: Email: behdasht3@mums.ac.ir Web page address:
#2
Name of recruitment center - English: Imam Reza health centers
Name of recruitment center - Persian: پایگاه بهداشتی امام رضا
Full name of responsible person - English: Dr. Mohammad javad Jamal khoo
Full name of responsible person - Persian: دکتر محمد جواد جمال خو
Street address - English: 45th Resalat; Resalat Street
Street address - Persian: خیابان رسالت; رسالت 45
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: mousavi ghochani health centers
Name of recruitment center - Persian: پایگاه بهداشتی موسوی قوچانی
Full name of responsible person - English: Dr. Mohammad javad Jamal khoo
Full name of responsible person - Persian: دکتر محمد جواد جمال خو
Street address - English: Corner of 3rd Floor Nazeran, Abutaleb 14
Street address - Persian: ابوطالب 14. نبش خوابگاه ناظران طبقه 3
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 51 3713 9301
Fax:
Email: behdasht3@mums.ac.ir
Web page address:
Name of recruitment center - English: Imam Rezamousavi ghochani health centers Name of recruitment center - Persian: پایگاه بهداشتی امام رضاموسوی قوچانی Full name of responsible person - English: Dr. Mohammad javad Jamal khoo Full name of responsible person - Persian: دکتر محمد جواد جمال خو Street address - English: 45th Resalat; Resalat StreetCorner of 3rd Floor Nazeran, Abutaleb 14 Street address - Persian: خیابان رسالت; رسالت 45ابوطالب 14. نبش خوابگاه ناظران طبقه 3 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 51 3713 9301 Fax: Email: behdasht3@mums.ac.ir Web page address:
#3
Name of recruitment center - English: Nikanam health center
Name of recruitment center - Persian: پایگاه بهداشتی نیکنام
Full name of responsible person - English: Dr. Asna ashari
Full name of responsible person - Persian: دکتر اثنی عشری
Street address - English: Hojjati clinic; Hojjat alley; Ebadi Street
Street address - Persian: خیابان عبادی; کوچه حجتی; درمانگاه حجتی
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: Motahhari health center
Name of recruitment center - Persian: پایگاه بهداشتی مطهری
Full name of responsible person - English: Dr. Asna ashari
Full name of responsible person - Persian: دکتر اثنی عشری
Street address - English: Corner Motahhari 26
Street address - Persian: نبش مطهری 26
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 51 3724 0079
Fax:
Email: behdasht3@mums.ac.ir
Web page address:
Name of recruitment center - English: NikanamMotahhari health center Name of recruitment center - Persian: پایگاه بهداشتی نیکناممطهری Full name of responsible person - English: Dr. Asna ashari Full name of responsible person - Persian: دکتر اثنی عشری Street address - English: Hojjati clinic; Hojjat alley; Ebadi StreetCorner Motahhari 26 Street address - Persian: خیابان عبادی; کوچه حجتی; درمانگاه حجتینبش مطهری 26 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 51 3724 0079 Fax: Email: behdasht3@mums.ac.ir 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 و فناوری دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
Street address - Persian: مشهد; خیابان دانشگاه; جنب سینما هویزه; دانشگاه علوم پزشکی مشهد; معاونت پژوهش و فناوری دانشگاه; شماره تماس 38411538-051
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 و فناوری دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mohsen Tafaghodi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
Street address - Persian: مشهد; خیابان دانشگاه; جنب سینما هویزه; دانشگاه علوم پزشکی مشهد; معاونت پژوهش و فناوری دانشگاه; شماره تماس 38411538-051
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3859 1511
Fax:
Email: presidentoffice@mums.ac.ir
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 و فناوری دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Mohsen Tafaghodi Full name of responsible person - Persian: محسن تفقدی Street address - English: Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad Street address - Persian: مشهد; خیابان دانشگاه; جنب سینما هویزه; دانشگاه علوم پزشکی مشهد; معاونت پژوهش و فناوری دانشگاه; شماره تماس 38411538-051 City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3859 1511 Fax: Email: presidentoffice@mums.ac.ir 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: Fatemeh Jalalmarvi
Full name of responsible person - Persian: فاطمه جلال مروی
Position - English: Counseling in Midwifery student
Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
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:
Fax:
Email: Jalalmarvif941@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: Fatemeh Jalalmarvi
Full name of responsible person - Persian: فاطمه جلال مروی
Position - English: Counseling in Midwifery student
Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی
Latest degree: master
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3859 1511
Mobile: +98 915 008 3034
Fax:
Email: Jalalmarvif941@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: Fatemeh Jalalmarvi Full name of responsible person - Persian: فاطمه جلال مروی Position - English: Counseling in Midwifery student Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی Latest degree: master Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ibn Sina street; Doctora Crossroads Street address - Persian: چهارراه دکترا; خیابان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3859 1511 Mobile: +98 915 008 3034 Fax: Email: Jalalmarvif941@mums.ac.ir Web page address:
Person responsible for scientific 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: Masumeh Kordi
Full name of responsible person - Persian: معصومه کردی
Position - English: Master of Midwifery
Position - Persian: 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: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
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: Kordim@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: Masumeh Kordi
Full name of responsible person - Persian: معصومه کردی
Position - English: Master of Midwifery
Position - Persian: 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: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3859 1511
Mobile: +98 915 511 4309
Fax:
Email: Kordim@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: Masumeh Kordi Full name of responsible person - Persian: معصومه کردی Position - English: Master of Midwifery Position - Persian: 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: Ibn Sina street; Doctora Crossroads Street address - Persian: چهارراه دکترا; خیابان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3859 1511 Mobile: 00+98 915 511 4309 Fax: Email: Kordim@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: داشگاه علوم پزشکی مشهد
Full name of responsible person - English: Fatemeh Jalalmarvi
Full name of responsible person - Persian: فاطمه جلال مروی
Position - English: Counseling in Midwifery Student
Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
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: Jalalmarvif941@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: داشگاه علوم پزشکی مشهد
Full name of responsible person - English: Fatemeh Jalalmarvi
Full name of responsible person - Persian: فاطمه جلال مروی
Position - English: Counseling in Midwifery Student
Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی
Latest degree: master
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina street; Doctora Crossroads
Street address - Persian: چهارراه دکترا; خیابان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3859 1511
Mobile: +98 915 008 3034
Fax:
Email: Jalalmarvif941@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: داشگاه علوم پزشکی مشهد Full name of responsible person - English: Fatemeh Jalalmarvi Full name of responsible person - Persian: فاطمه جلال مروی Position - English: Counseling in Midwifery Student Position - Persian: دانشجو کارشناسی ارشد مشاوره در مامایی Latest degree: master Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ibn Sina street; Doctora Crossroads Street address - Persian: چهارراه دکترا; خیابان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3859 1511 Mobile: 00+98 915 008 3034 Fax: Email: Jalalmarvif941@mums.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Because the study is not finished yet.
Because the study is not finished yet.
empty
به علت این که هنوز مطالعه تمام نشده است.
به علت این که هنوز مطالعه تمام نشده است.
Protocol summary
Study aim
To compare the effect of education on continuous care model and tele-care (telehealth) model on the quality of sleep in pregnant women
Design
Three groups of clinical trials with a control group, community based and pragmatic, parallel groups,no blind, randomized.
Settings and conduct
This randomized, three-group study was performed in Mashhad's health centers.
After confirmation of the research by the Ethics Committee of Mashhad University of Medical Sciences and expressing the goals of studying and satisfying the pregnant women and obtaining written consent from them, and taking into account ethical codes, the sample was selected and carried out.
Participants/Inclusion and exclusion criteria
Women aged 35-18;Pregnancy with one fetus with gestational age of 16 to 20 weeks and 5 scores or more in the Pittsburgh Sleep Quality Questionnaire (PSQI).
Intervention groups
For the follow-up care group,first an introductory meeting (familiarization) will be held, then 4 sessions will be held in 4 weeks, and communication with his family will be established by telephone and booklet (sensitization). Then, within three weeks, a 10-minutes phone call will be established (control) and, finally, the quality of sleep will be reviewed immediately and 4 weeks later (a total of 12 weeks). In the telehealth group, an awareness session is initiated first, then 4 encoded CDs are provided to mothers and it is recommended that you watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks ), Telephone counseling is done for 10-15 minutes (once a week) and the quality of sleep will be assessed immediately and 4 weeks after the intervention (a total of 12 weeks). For the control group, the usual care was taken by the health centers.
Main outcome variables
Sleep quality in pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017060734378N1
Registration date:2017-07-15, 1396/04/24
Registration timing:prospective
Last update:2018-05-12, 1397/02/22
Update count:1
Registration date
2017-07-15, 1396/04/24
Registrant information
Name
Fatemeh Jalalmarvi
Name of organization / entity
Islamic Azad University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3751 5211
Email address
jalalmarvif941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad.
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2017-07-23, 1396/05/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Comparing the effect of training, based on continuous care model and a telehealth on pregnant women sleeping quality
Public title
Comparing the effect of training, based on continuous care model and a telehealth on sleeping quality
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
have Spontaneous written consent
Being Iranian and resident of Mashhad
The gestational age is between 16 and 20 weeks
Pregnancies with one fetus
Mother`s age between 18 to 35
The least literacy of mother and her husband be about fifth grade elementary school
In response to the Pittsburgh Sleep Quality Questionnaire, she earns 5 scores and more
In response to the restless leg assessment Questionnaire, she earns 3-0 scores
In response to STOP Questionnaire , she earns 2-0 scores
In response to question 1, the intensity of ISI Questionnaire , she earns 0-5 scores
In response to stress , anxiety and depression Questionnaire less than 10, 14, and 17 scores were obtained from depression, anxiety and stress levels;
Having fixed or mobile phone numbers
Exclusion criteria:
linguistic, audio or dialectal problems
Having sleep disorders history before pregnancy
A bad important event has been occured from three months before the commencement of the study
Having medical disease
Having mental illness
Having midwifery problems
Having history of infertility and the current pregnancy does be a result of infertility treatment
Pre-pregnancy BMI does be equal to or greater than 30
Having addiction to tobacco (hookah, cigarettes, cheeks, drugs) or alcohol and psychosocial drugs, research unit or his husband
During the research she does have night shift work
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
91
Randomization (investigator's opinion)
Randomized
Randomization description
The name of the center has been used to randomize the lottery method.
Lottery in the name of health centers has been done to locate each group in each health facility.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Contact Number 38411538-051; Fax Number 38430249-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2017-06-03, 1396/03/13
Ethics committee reference number
IR.MUMS.REC.1396.68
Health conditions studied
1
Description of health condition studied
Sleep
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnia]
Primary outcomes
1
Description
Sleep quality
Timepoint
Before the intervention, immediately after intervention and 4 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Severe insomnia
Timepoint
Before, immediately after and 4 weeks after intervention
Method of measurement
Insomnia Severity Index
Intervention groups
1
Description
Control group: usual care health center receives over 8 weeks
Category
N/A
2
Description
Intervention 2: In the Telehealth group, first they become familiar with the stages of the research between the 16th to 20th weeks of pregnancy (30-45 minutes), then 4 coded CDs (60-65 minutes) with the contents of the health and healthy behaviors during sleep is given to moms and they will be advised to watch a CD every week, during these 4 weeks and 4 weeks after that (8 weeks), telephone counseling is provided for 10-15 minutes based on the need of the patient (once a week ), Each telephone consultation includes 2 sections, the first part of the consultation is based on the content of the weekly CD, and the second part will be dedicated to the specific needs of each client and the presentation of proposed solutions. Then, the quality of sleep will be evaluated immediately and 4 weeks after the intervention (totally 12 weeks).
Category
N/A
3
Description
Intervention 1: In the group which its education is based on continuous care model, in first meeting (45-30 minutes) pregnant women in 16 to 20 weeks of pregnancy with a family member, after completing the survey device, become familiar with the research steps (orientation) then four 90-60 minutes sessions with consultation, discussion and Q & A ,with the contents of the health and healthy behaviors during sleep are held in 4 weeks and communication with his family is established by phone and booklet(sensitization ).If, it is needed, to study new problems, maintaining connection with mother, answer to her questions and review the lists some meetings with phone calls (10 minutes)will be held (control) and in the evaluation phase, sleep quality will be discussed immediately and 4 weeks later (totally 12 weeks)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iesargaran health center
Full name of responsible person
Dr. Tabibzadeh
Street address
Hedayat 1, Hedayat Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3733 9855
Email
behdasht3@mums.ac.ir
2
Recruitment center
Name of recruitment center
mousavi ghochani health centers
Full name of responsible person
Dr. Mohammad javad Jamal khoo
Street address
Corner of 3rd Floor Nazeran, Abutaleb 14
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3713 9301
Email
behdasht3@mums.ac.ir
3
Recruitment center
Name of recruitment center
Motahhari health center
Full name of responsible person
Dr. Asna ashari
Street address
Corner Motahhari 26
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3724 0079
Email
behdasht3@mums.ac.ir
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 Tafaghodi
Street address
Contact Number 38411538-051; Deputy of Research & Technology University; Mashhad University of Medical Sciences; next to Hoveizeh Cinema; University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Email
presidentoffice@mums.ac.ir
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
Fatemeh Jalalmarvi
Position
Counseling in Midwifery student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Fax
Email
Jalalmarvif941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masumeh Kordi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Fax
Email
Kordim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Jalalmarvi
Position
Counseling in Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ibn Sina street; Doctora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Fax
Email
Jalalmarvif941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available