History
# Registration date Revision Id
2 2021-04-04, 1400/01/15 190052
1 2017-06-30, 1396/04/09 24912
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  • Protocol summary

    This research aimed to compare the effect of preoperative training approach by nurse and peer on women's anxiety undergoing ovarian puncture. This is a non-blinded randomized clinical trial. The participants were the ovarian puncture candidates aged 18-45 who visited Yazd Infertility Center, Iran. After convenience sampling, the participants were assigned into three groups (Nurse Training, Peer Training, and Control) through block randomization method. There were 70 participants in each group. The two-part questionnaire (Demographic and Spielberger) will be completed at the time of admission. Then, two training groups received training prior to the surgery. Anxiety Questionnaire was completed immediately before going to the operation room and before discharge by all three groups. Training was as follows: In the lecture method, a nurse and a trained peer provided the patients with discussions, questions, and answers for 30 to 60 minutes after they filled out the admission anxiety questionnaire. The peer in this study had already passed the necessary trainings about the content of the training program in two sessions by the same nurse in order to unify the educational content in the two groups. The samples of the control group didn’t receive any preoperative training. According to the routine practices of the ward, the samples received postoperative care training by the ward nurse for 30 minutes after surgery. The main outcome in this study was anxiety.
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    هدف : مقایسه تاثیر رویکردهای آموزش قبل از عمل توسط پرستار و همتا بر اضطراب زنان کاندید عمل پونکسیون تخمدان. این مطالعه کارآزمایی بالینی تصادفی شده به صورت کور نشده می باشد. شرکت کنندگان زنان 18 تا 45 ساله کاندید پونکسیون تخمدان مراجعه کننده به مرکز ناباروری یزد خواهند بود. پس از نمونه گیری آسان، به صورت تصادفی بلوکه شده به یکی از سه گروه آموزش پرستار، آموزش همتا و گروه کنترل (هرگروه 70 نفر) تخصیص داده می شوند. پرسشنامه دو بخشی مورد نظر(دموگرافیک و اسپیل برگر) در زمان پذیرش تکمیل خواهد شد. سپس دو گروه آموزشي قبل از جراحي آموزش داده شدند آن گاه دو نوبت دیگر(بلافاصله قبل از انتقال به اتاق عمل، و قبل از ترخیص) هر سه گروه به تکمیل پرسشنامه اضطراب مبادرت خواهند نمود.برنامه آموزش به ترتیب زیر خواهد بود: بعد از اینکه بیماران پرسشنامه اضطراب پذیرش را تکمیل کردند توسط پرستار و همتای آموزش دیده، به مدت 30 الی 60 دقیقه با روش سخنرانی، بحث و پرسش و پاسخ آموزش های لازم را خواهند دید. فرد همتا در این مطالعه، قبلاً در طی دو جلسه آموزش های لازم راجع به محتوای آموزشی را توسط همان پرستار برای یکسان سازی محتوا در دو گروه را گذرانده است. نمونه های گروه کنترل هیچ گونه آموزشی در دوره قبل از عمل نخواهند داشت. آنها طبق روتین بخش، بعد از عمل توسط پرستار بخش به مدت 30 دقیقه آموزش مراقبتهای پس از عمل را می بینند. پیامد اصلی مورد بررسی در این مطالعه اضطراب می باشد.
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    Comparing the Effects of nurse and peer-Based Education Methods on the pre-‎operative anxiety of Surgery candidate infertile women
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    ‏مقایسه تاثیر رویکردهای آموزش توسط پرستار و همتا بر اضطراب قبل از عمل زنان نابارور‏
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    Clinical trial with three groups of nurse education, peer education and control, Permutation on 198 patients randomized blocks. Random Allocation software was used for randomization.
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    کارآزمایی بالینی دارای سه گروه آموزش پرستار،آموزش ‏همتا و کنترل ، تصادفی به روش بلوک‌های جایگشتی بر روی 198 بیمار.برای تصادفی سازی از نرم افزار Random Allocation استفاده شد.
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    This study was performed in the period of February 2017 to August 2017 at the Infertility Research ‎Center in Yazd, Iran. In this clinical trial, 210 eligible people were selected from 240 members of ‎the available population. .The samples were selected by availability and assigned randomly to the three groups of nurse training, peer training and control by permutation block method.The number of samples in each group was 70 people.
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    این مطالعه در محدوده زمانی فوریه 2017 تا آگوست 2017 در مرکز تحقیقات ناباروری یزد ، ایران انجام شد. در این کارآزمایی ‏بالینی از بین 240 نفر جامعه در دسترس، 210 نفر از افراد واجد شرایط مطالعه انتخاب شدند. ‎‏ ‏‎انتخاب نمونه‌ها به صورت در دسترس و تخصیص آنها به صورت تصادفی به روش بلوک‌های جایگشتی به سه گروه آموزش پرستار،آموزش ‏همتا و کنترل انجام گرفت. تعداد نمونه در هر گروه 70 نفر بود.
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    Our inclusion criteria were as follows: age between 18 and 45 yr, knowledge persian language, ‎and literate. Women with mental illness, addiction, egg donor,‎‏ ‏cancer and those taking anti-‎anxiety medications were excluded. ‎
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    معیارهاي ورود به مطالعه شامل زنان سنین45- 18 سال ،فارسی زبان و دارای سواد خواندن و نوشتن بود. معیارهاي خروج از مطالعه ‏شامل ابتلا به بیماري روانی، اعتیاد ، اهداکننده تخمک، سرطان و مصرف داروهاي ضد اضطراب بود. ‏
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    Training group by nurse Training group by peer Control group The two intervention groups were trained by the nurse and peers after collecting data on the day of admission. However, the control group samples were trained according to the routine section only at the time of discharge.
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    ‏گروه آموزش توسط پرستار ‏گروه آموزش توسط همتا ‏گروه کنترل ‏ دو گروه مداخله توسط پرستار و همتا بعد از جمع آوری داده در روز پذیرش، تحت آموزش قرار گرفتند. ولی نمونه های گروه کنترل طبق روتین بخش، فقط در زمان ترخیص آموزش ‏داشتند. ‏
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    Anxiety
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    اضطراب
  • General information

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    198
    No
    No
    2017-01-29, 1395/11/10
    2017-01-20, 1395/11/01
    2017-08-01, 1396/05/10
    2017-08-21, 1396/05/30
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    2017-02-13, 1395/11/25
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    2017-08-01, 1396/05/10
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    2017-08-01, 1396/05/10
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    Description of randomization
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    توصیف تصادفی سازی
    Comparison of the effect of pre-operative training by nurse and peer on the anxiety of women undergoing ovarian puncture.
    Comparison of effect of pre-operative educational ‎approach by nurses and peers on anxiety of the women ‎undergoing ovarian puncture
    مقایسه تاثیر رویکردهای آموزش قبل از عمل توسط پرستار و همتا بر اضطراب زنان کاندید عمل پونکسیون تخمدان.
    مقایسه تاثیر رویکردهای آموزش قبل از عمل توسط پرستار و همتا بر ‏اضطراب زنان کاندید عمل پونکسیون تخمدان
    Candidate patients undergo ovarian puncture
    Willingness to participate in the study
    Age between 18 and 45 years
    knowledge persian language
    Literacy for reading and writing
    ‏بیماران کاندید انجام عمل پونکسیون تخمدان‏ ‏
    تمایل به شرکت در مطالعه‏
    سن بین 18 تا 45 سال
    فارسی زبان‏
    سواد خواندن و نوشتن
    Mental illness, addiction, cancer
    Taking anti-anxiety drugs
    Donor
    ‏ابتلا به بیماري روانی، اعتیاد، سرطان‏‏ ‏
    مصرف داروهاي ضد اضطراب
    اهدا کننده تخمک
    The method of randomization in this study is block randomization
    In this study, individuals were assigned to three groups using permutation block method.
    تقیسم گروها به صورت تصادفی بلوک بندی شده می باشد.
    در این مطالعه تخصیص افراد به سه گروه با استفاده از روش بلوک جایگشتی انجام شد.
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    Sampling was performed using special randomized software with permutation block method with a volume of 6 people and eligible samples were placed in one of the three groups of nurse training, peer training and control.
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    نمونه گیری با استفاده از نرم افزار اختصاصی تصادفی به روش بلوک جایگشتی با حجم ۶ نفر انجام شد و نمونه های واجد شرایط در ‏‏یکی از سه گروه آموزش پرستار، آموزش همتا و کنترل قرار گرفتند.
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  • Ethics committees

    #1
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    2017-02-12, 1395/11/24
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    IR.SSU.RSI.REC.1395.30
  • Primary outcomes

    #1
    Anxiety.
    Anxiety
    اضطراب.
    اضطراب
    Baseline, preoperative, before discharge.
    Baseline, preoperative
    بدو مطالعه، قبل از عمل، قبل از ترخیص.
    بدو مطالعه، قبل از عمل
    Spielberger questionnaire.
    Spielberger questionnaire
    پرسشنامه اسپیل برگر.
    پرسشنامه اسپیل برگر
  • Intervention groups

    #1
    Preoperative training by a nurse: through the lecture method, a nurse provides the patients with discussions, questions, and answers during 30 to 60 minutes after they fill out the admission anxiety questionnaire. The content is comprised of description of the type of surgery (based on patient’s medical record), patient transfer time to the operating room, approximate duration of surgery, introduction of non-pharmacological stress reduction techniques such as deep breath, postoperative diet, how to take medications, side effects of medications, quality and amount of sleep, and postoperative physical activity.
    Preoperative training by a nurse: The nurse-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the nurse was allowed to express positive experiences. The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery).
    آموزش قبل از عمل توسط پرستار: بعد از اینکه بیماران پرسشنامه اضطراب پذیرش را تکمیل کردند توسط پرستار به مدت 30 الی 60 دقیقه با روش سخنرانی، بحث و پرسش و پاسخ آموزش های لازم را خواهند دید محتوای آموزشی شامل نوع عمل جراحی طبق پرونده، زمان بردن به اتاق عمل، مدت زمان تقریبی عمل، معرفی روش های غیر دارویی کاهنده استرس از قبیل تنفس عمیق، رژیم غذایی پس از عمل، نحوه مصرف داروها و عوارض داروها، کیفیت و میزان استراحت و فعالیت بعد از عمل می باشد.
    آموزش قبل از عمل توسط پرستار: گروه آموزش پرستار پس از تکمیل پرسشنامه اولیه، به مدت 30 الی 60 دقیقه با روش سخنرانی و پرسش و پاسخ تحت آموزش قرار گرفت. محتوای آموزشی ‏شامل نوع عمل جراحی، مدت زمان تقریبی عمل، مراقبت های بعد از عمل ‏IVF‏ از قبیل رژیم غذایی، نحوه مصرف داروها، ‏کیفیت و میزان استراحت و فعالیت بعد از عمل بود. در طی این آموزش، پرستار مجاز به بیان تجربیات مثبت بود. ‏پرسشنامه به صورت خودگزارش دهی در حضور محقق در زمان پذیرش (دو روز قبل از عمل) و پس از مداخله ‏‏(بلافاصله قبل از عمل) تکمیل شد. ‏
    #2
    Preoperative training by a peer: through the lecture method, a trained peer provides the patients with discussions, questions, and answers during 30 to 60 minutes after they fill out the admission anxiety questionnaire. The peer in this study has already passed the necessary trainings about the content of the training program in two sessions by the same nurse in order to unify the content in the two groups. The content is comprised of description of the type of surgery (based on patient’s medical record), patient transfer time to the operating room, approximate duration of surgery, introduction of non-pharmacological stress reduction techniques such as deep breath, postoperative diet, how to take medications, side effects of medications, quality and amount of sleep, and postoperative physical activity. In addition, the peer shares his/her personal experience and the positive experience of his/her acquaintances or peers.
    Preoperative training by a peer: The peer-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the peer was allowed to express positive experiences. To educate the peer group, three qualified peerswere selected according to the following criteria:history of successful ovarian puncture, high schooldiploma or higher, and having low levels of anxietybased on the STAI. These selected peers wereeducated before sampling by the nurse educatorof another group about their roles in the study,the importance of instructing patients, and theeducational content in two sessions. Then, throughan experimental instruction, one of the peers wasselected as the educator for the peer-educatedgroup. She was a 24-yr-old housewife and aresident of Yazd who had a high school diplomaand a child from IVF.The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery)
    آموزش قبل از عمل توسط همتا: بعد از اینکه بیماران پرسشنامه اضطراب پذیرش را تکمیل کردند توسط همتای آموزش دیده، به مدت 30 الی 60 دقیقه با روش سخنرانی، بحث و پرسش و پاسخ آموزش های لازم را خواهند دید. فرد همتا در این مطالعه، قبلاً در طی دو جلسه آموزش های لازم راجع به محتوای آموزشی را توسط همان پرستار برای یکسان سازی محتوا در دو گروه را گذرانده است. محتوای آموزشی شامل نوع عمل جراحی طبق پرونده، زمان بردن به اتاق عمل، مدت زمان تقریبی عمل، معرفی روش های غیر دارویی کاهنده استرس از قبیل تنفس عمیق، رژیم غذایی پس از عمل، نحوه مصرف داروها و عوارض داروها، کیفیت و میزان استراحت و فعالیت بعد از عمل می باشد. علاوه بر آن همتا تجربیات شخصی خود و سایر آشنایان یا همتایان دارای تجربه مثبت خواهد پرداخت.
    آموزش قبل از عمل توسط همتا: گروه آموزش همتا، پس از تکمیل پرسشنامه اولیه، به مدت 30 الی 60 دقیقه با روش سخنرانی و پرسش و پاسخ تحت آموزش قرار گرفت. محتوای آموزشی ‏شامل نوع عمل جراحی، مدت زمان تقریبی عمل، مراقبت های بعد از عمل ‏IVF‏ از قبیل رژیم غذایی، نحوه مصرف داروها، ‏کیفیت و میزان استراحت و فعالیت بعد از عمل بود. در طی این آموزش، فرد همتا مجاز به بیان تجربیات مثبت بود. ‏برای آموزش گروه همتا، سه نفر همتای واجد شرایط انتخاب شدند. معیارهای همتای منتخب: سابقه عمل پونکسیون تخمدان ‏موفق در سال های قبل، داوطلب همکاری با پژوهشگر، دارای سطح تحصیلات دیپلم به بالا و اضطراب خفیف بر اساس ‏پرسشنامـۀ اضطراب آشکـار اشپیل برگر بود. این افراد قبل از آغاز نمونه گیری، در طی دو جلسه توسط پرستار آموزش دهنده ‏گروه دیگر در مورد نقش آن ها در مطالعه، اهمیت آموزش به بیمار و محتوای آموزشی آموزش دیدند. سپس با اجرای آزمایشی ‏آموزش به بیمار، یک نفر از آن ها انتخاب و برای آموزش گروه همتا با پژوهشگر همکاري كرد. وی خانم 24 ساله، ساكن یزد، ‏خانه دار، دارای تحصيلات ديپلم و یک فرزند حاصل از ‏IVF‏ بود. پرسشنامه به صورت خودگزارش دهی در حضور محقق در زمان پذیرش (دو روز قبل از عمل) و پس از مداخله ‏‏(بلافاصله قبل از عمل) تکمیل شد. ‏ ‏
    #3
    The samples of the control group do not receive any preoperative training. The preoperative admission questionnaire is filled out. According to the routine practices on the ward, the samples receive postoperative care training by the ward nurse for 30 minutes after surgery, and then the pre-discharge anxiety questionnaire is filled out. This training program is implemented for all three groups in a similar way before discharge
    the control group was only educated at the time of their discharge, which is part of the section’s routines.
    نمونه های گروه کنترل هیچ گونه آموزشی در دوره قبل از عمل نخواهند داشت. پرسشنامه پذیرش و قبل از عمل تکمیل میشود سپس آن ها طبق روتین بخش، بعد از عمل توسط پرستار بخش به مدت 30 دقیقه آموزش مراقبتهای پس از عمل را می بینند و سپس پرسشنامه اضطراب قبل از ترخیص نیز تکمیل می شود. این برنامه آموزشی برای هر سه گروه قبل از ترخیص بطور یکسان اجرا خواهد شد.
    گروه کنترل طبق روتین بخش، فقط در زمان ترخیص آموزش داشتند. ‏
  • Recruitment centers

    #1
    Name of recruitment center - English: Yazd Reproduction Sciences Institute
    Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Street address - English: Bouali avenue, timsar falahi street, Yazd.
    Street address - Persian: یزد خیابان تیمسار فلاحی خیابان بو علی
    City - English: Yazd
    City - Persian: یزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Yazd Reproduction Sciences Institute
    Name of recruitment center - Persian: پژوهشکده علوم تولید مثل یزد
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Street address - English: Bouali avenue, timsar falahi street, Yazd.
    Street address - Persian: یزد خیابان تیمسار فلاحی خیابان بو علی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax: +98 35 3824 7087
    Email: yazd-rsi@ssu.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research,Yazd University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی یزد
    Full name of responsible person - English: Ms. Morshedyan
    Full name of responsible person - Persian: خانم مرشدیان
    Street address - English: Yazd University of Medical Sciences, Bahonar Square
    Street address - Persian: میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی یزد
    City - English: yazd
    City - Persian: یزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: .
    Full name of responsible person - Persian: .
    Street address - English: Yazd University of Medical Sciences, Bahonar Square
    Street address - Persian: میدان باهنر حوزه ستادی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی یزد
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: info@ssu.ac.ir
    Web page address:
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    Public
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    Domestic
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    Academic
    Vice chancellor for research,Yazd University of Medical Sciences
    Yazd University of Medical Sciences
    معاونت پژوهشی دانشگاه علوم پزشکی یزد
    دانشگاه علوم پزشکی یزد
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Yazd University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یزد
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Position - English: Master Student in Nursing
    Position - Persian: دانشجوی کارشناس ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safaeyeh, Yazd
    Street address - Persian: یزدصفاییه خ بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 3525 2291
    Mobile: +98 913 259 0449
    Fax:
    Email: a.kalantari@ssu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Position - English: Master in Nursing
    Position - Persian: کارشناس ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Safaeyeh, Yazd
    Street address - Persian: یزدصفاییه خ بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3525 2291
    Mobile: +98 913 259 0449
    Fax:
    Email: a.kalantari@ssu.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Yazd University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یزد
    Full name of responsible person - English: Farahnaz Farnia
    Full name of responsible person - Persian: خانم دکتر فرحناز فرنیا
    Position - English: Ph.D in Nursing
    Position - Persian: دکتری پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Timsar Falahi street
    Street address - Persian: یزد خ تیمسار فلاحی خ بو علی دانشکده پرستاری مامایی
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 3824 5777
    Mobile: +98 913 258 6440
    Fax:
    Email: farnia@ssu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farahnaz Farnia
    Full name of responsible person - Persian: خانم دکتر فرحناز فرنیا
    Position - English: Ph.D in Nursing
    Position - Persian: دکتری پرستاری
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Timsar Falahi street
    Street address - Persian: یزد خ تیمسار فلاحی خ بو علی دانشکده پرستاری مامایی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 916777443
    Phone: +98 35 3824 5777
    Mobile: +98 913 258 6440
    Fax:
    Email: farnia@ssu.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Yazd University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید صدوقی یزد
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Position - English: Master student in nursing
    Position - Persian: دانشجوی کارشناس ارشد پرستاری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Timsar falahi street
    Street address - Persian: یزد خ تیمسار فلاحی خ بو علی
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 3525 2291
    Mobile: +98 913 259 0449
    Fax:
    Email: a.kalantari@ssu.ac.ir; kalantariathara@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Atharah Kalantari
    Full name of responsible person - Persian: اطهره کلانتری
    Position - English: Master student in nursing
    Position - Persian: دانشجوی کارشناس ارشد پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali Ave, Timsar falahi street
    Street address - Persian: یزد خ تیمسار فلاحی خ بو علی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8917735513
    Phone: +98 35 3525 2291
    Mobile: +98 913 259 0449
    Fax:
    Email: kalantariathara@gmail.com
    Web page address:
  • Sharing plan

    yes
    yes
    undecided
    undecided
    yes
    undecided
    undecided
    empty
    The data from the study were published as an article.
    empty
    داده های حاصل از مطالعه به صورت مقاله منتشر شد.
    empty
    Since 1401
    empty
    از سال 1401
    empty
    All people in the field of medicine and nursing
    empty
    همه افراد در حوزه پزشکی و پرستاری
    empty
    To reduce preoperative anxiety in surgical candidates
    empty
    برای کاهش اضطراب قبل از عمل افراد کاندید جراحی
    empty
    Email to the person performing the project
    empty
    ایمیل به فرد مجری طرح
    empty
    Email to the moderator - Request from the Vice Chancellor for Research- If yes, provide information to the applicant
    empty
    ایمیل به فرد مجری - تقاضا از معاونت پژوهشی دانشگاه- در صورت مثبت بودن ارایه اطلاعات به فرد متقاضی

Protocol summary

Study aim
Comparing the Effects of nurse and peer-Based Education Methods on the pre-‎operative anxiety of Surgery candidate infertile women
Design
Clinical trial with three groups of nurse education, peer education and control, Permutation on 198 patients randomized blocks. Random Allocation software was used for randomization.
Settings and conduct
This study was performed in the period of February 2017 to August 2017 at the Infertility Research ‎Center in Yazd, Iran. In this clinical trial, 210 eligible people were selected from 240 members of ‎the available population. .The samples were selected by availability and assigned randomly to the three groups of nurse training, peer training and control by permutation block method.The number of samples in each group was 70 people.
Participants/Inclusion and exclusion criteria
Our inclusion criteria were as follows: age between 18 and 45 yr, knowledge persian language, ‎and literate. Women with mental illness, addiction, egg donor,‎‏ ‏cancer and those taking anti-‎anxiety medications were excluded. ‎
Intervention groups
Training group by nurse Training group by peer Control group The two intervention groups were trained by the nurse and peers after collecting data on the day of admission. However, the control group samples were trained according to the routine section only at the time of discharge.
Main outcome variables
Anxiety

General information

Reason for update
Description of randomization
Acronym
IRCT registration information
IRCT registration number: IRCT2017010331753N1
Registration date: 2017-06-30, 1396/04/09
Registration timing: registered_while_recruiting

Last update: 2021-07-12, 1400/04/21
Update count: 1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Atharah Kalantari
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 259 0449
Email address
a.kalantari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Yazd University of Medical Sciences.
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2017-02-13, 1395/11/25
Actual recruitment end date
2017-08-01, 1396/05/10
Trial completion date
2017-08-01, 1396/05/10
Scientific title
Comparison of effect of pre-operative educational ‎approach by nurses and peers on anxiety of the women ‎undergoing ovarian puncture
Public title
Comparison of two method of preoperative training on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients undergo ovarian puncture Willingness to participate in the study Age between 18 and 45 years knowledge persian language Literacy for reading and writing
Exclusion criteria:
Mental illness, addiction, cancer Taking anti-anxiety drugs Donor
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 210
Actual sample size reached: 198
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed using special randomized software with permutation block method with a volume of 6 people and eligible samples were placed in one of the three groups of nurse training, peer training and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, individuals were assigned to three groups using permutation block method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.SSU.REC.1395.202

2

Ethics committee
Name of ethics committee
Ethics committee Research and Clinical Center for Infertility, Yazd, Iran
Street address
Safaieh ، Bouali Street
City
yazd
Province
Yazd
Postal code
8916877391
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.SSU.RSI.REC.1395.30

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
generalized anxiety disorder

2

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Anxiety
Timepoint
Baseline, preoperative
Method of measurement
Spielberger questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Preoperative training by a nurse: The nurse-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the nurse was allowed to express positive experiences. The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery).
Category
Prevention

2

Description
Preoperative training by a peer: The peer-educated group was on 30-60 min group education program after the completion of the primary questionnaire.The educational package contained the type and duration of surgery, postoperative cares, including diet, medicine consumption, the qualityand amount of rest after surgery, and postoperative activity. During this education, the peer was allowed to express positive experiences. To educate the peer group, three qualified peerswere selected according to the following criteria:history of successful ovarian puncture, high schooldiploma or higher, and having low levels of anxietybased on the STAI. These selected peers wereeducated before sampling by the nurse educatorof another group about their roles in the study,the importance of instructing patients, and theeducational content in two sessions. Then, throughan experimental instruction, one of the peers wasselected as the educator for the peer-educatedgroup. She was a 24-yr-old housewife and aresident of Yazd who had a high school diplomaand a child from IVF.The questionnaire was filled out in a self-reportmanner in the researcher’s presence at the timeof admission (two days before the operation) andimmediately after the intervention (prior to surgery)
Category
Prevention

3

Description
the control group was only educated at the time of their discharge, which is part of the section’s routines.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Reproduction Sciences Institute
Full name of responsible person
Atharah Kalantari
Street address
Bouali avenue, timsar falahi street, Yazd.
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
yazd-rsi@ssu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
.
Street address
Yazd University of Medical Sciences, Bahonar Square
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Atharah Kalantari
Position
Master in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bouali Ave, Safaeyeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3525 2291
Fax
Email
a.kalantari@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Farahnaz Farnia
Position
Ph.D in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bouali Ave, Timsar Falahi street
City
Yazd
Province
Yazd
Postal code
916777443
Phone
+98 35 3824 5777
Fax
Email
farnia@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atharah Kalantari
Position
Master student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bouali Ave, Timsar falahi street
City
Yazd
Province
Yazd
Postal code
8917735513
Phone
+98 35 3525 2291
Fax
Email
kalantariathara@gmail.com
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
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
Yes - There is 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
Title and more details about the data/document
The data from the study were published as an article.
When the data will become available and for how long
Since 1401
To whom data/document is available
All people in the field of medicine and nursing
Under which criteria data/document could be used
To reduce preoperative anxiety in surgical candidates
From where data/document is obtainable
Email to the person performing the project
What processes are involved for a request to access data/document
Email to the moderator - Request from the Vice Chancellor for Research- If yes, provide information to the applicant
Comments
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