The effect of counseling with the method of happiness training based on cognitive behavioral model on the stress of infertile women: a randomized controlled trial
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Protocol summary
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تک سویه کور، تصادفی شده، فاز3 بر روی 60 زن نابارور. برای تصادفی سازی از روش بلوک بندی تصادفی طبقه‌بندی شده استفاده خواهدشد
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تک سویه کور، تصادفی شده، فاز 3 بر روی 60 زن نابارور. برای تصادفی سازی از روش بلوک بندی تصادفی طبقه‌بندی شده استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، تک سویه کور، تصادفی شده، فاز3فاز 3 بر روی 60 زن نابارور. برای تصادفی سازی از روش بلوک بندی تصادفی طبقه‌بندی شده استفاده خواهدشدخواهد شد.
The location of the research in this study is the infertility clinic of Al-Zahra educational and therapeutic center in Tabriz and the time of the research is 1403. In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model. The control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
The location of the research in this study is the infertility Center of Jahad Daneshgahi in Tabriz and the time of the research is 2024. In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model. The control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
The location of the research in this study is the infertility clinicCenter of Al-Zahra educational and therapeutic centerJahad Daneshgahi in Tabriz and the time of the research is 14032024. In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model. The control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
مکان پژوهش در این مطالعه، درمانگاه نازایی مرکز آموزشی و درمانی الزهرا شهر تبریز و زمان پژوهش سال 1403 می¬باشد.در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد. البته هردو گروه درمان روتین ناباروری خود را طبق نظر پزشک دریافت خواهند کرد
مکان پژوهش در این مطالعه، درمانگاه نازایی مرکز جهاد دانشگاهی شهر تبریز و زمان پژوهش سال 1403 میباشد.در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد. البته هردو گروه درمان روتین ناباروری خود را طبق نظر پزشک دریافت خواهند کرد.
مکان پژوهش در این مطالعه، درمانگاه نازایی مرکز آموزشی و درمانی الزهراجهاد دانشگاهی شهر تبریز و زمان پژوهش سال 1403 می¬باشد.درمیباشد.در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد. البته هردو گروه درمان روتین ناباروری خود را طبق نظر پزشک دریافت خواهند کرد.
Infertile women who will refer to the infertility clinic of Al-Zahra Medical Training Center in Tabriz for treatment
Infertile women who will refer to the infertility Center of Jahad Daneshgahi in Tabriz for treatment
Inclusion criteria:
1- Infertile women with at least one year of primary infertility and undergoing IVF treatment
2- Having at least basic literacy
3- Obtaining a minimum score of 184 on the Infertility Stress Questionnaire
Exclusion criteria:
1- Suffering from neurological and mental illnesses according to the patient's own statement
2- Suffering from chronic illnesses (kidney and liver failure, etc.)
3- Taking psychiatric medications according to the patient's own statement
4- Referral to a psychologist within the past few months due to infertility
5- Lack of confidence in being able to attend all counseling sessions
Infertile women who will refer to the infertility clinicCenter of Al-Zahra Medical Training CenterJahad Daneshgahi in Tabriz for treatment Inclusion criteria: 1- Infertile women with at least one year of primary infertility and undergoing IVF treatment 2- Having at least basic literacy 3- Obtaining a minimum score of 184 on the Infertility Stress Questionnaire Exclusion criteria: 1- Suffering from neurological and mental illnesses according to the patient's own statement 2- Suffering from chronic illnesses (kidney and liver failure, etc.) 3- Taking psychiatric medications according to the patient's own statement 4- Referral to a psychologist within the past few months due to infertility 5- Lack of confidence in being able to attend all counseling sessions
زنان ناباروری که جهت درمان به درمانگاه نازایی مرکز آموزشی درمانی الزهرا تبریز مراجعه خواهند کرد
زنان ناباروری که جهت درمان به درمانگاه نازایی مرکز جهاد دانشگاهی تبریز مراجعه خواهند کرد
معیارهای ورود:
1-زنان نابارور با حداقل یک سال سابقه نازایی اولیه و تحت درمان با IVF
2-داشتن حداقل سواد راهنمایی
3-کسب حداقل نمره 184 در پرسشنامه استرس ناباروری
معیار های عدم ورود به مطالعه:
1-ابتلا به بیماری های اعصاب و روان بنا به گفته خود بیمار
2-ابتلا به بیماری های مزمن (نارسایی کلیه و کبد و......)
3-مصرف داروهای روان پزشکی بنا به اظهار خود بیمار
4-مراجعه به روانشناس طی چند ماه گذشته به علت ناباروری فرد
5-عدم اطمینان به اینکه بتواند در تمام جلسات مشاوره شرکت نماید
زنان ناباروری که جهت درمان به درمانگاه نازایی مرکز آموزشی درمانی الزهراجهاد دانشگاهی تبریز مراجعه خواهند کرد معیارهای ورود: 1-زنان نابارور با حداقل یک سال سابقه نازایی اولیه و تحت درمان با IVF 2-داشتن حداقل سواد راهنمایی 3-کسب حداقل نمره 184 در پرسشنامه استرس ناباروری معیار های عدم ورود به مطالعه: 1-ابتلا به بیماری های اعصاب و روان بنا به گفته خود بیمار 2-ابتلا به بیماری های مزمن (نارسایی کلیه و کبد و......) 3-مصرف داروهای روان پزشکی بنا به اظهار خود بیمار 4-مراجعه به روانشناس طی چند ماه گذشته به علت ناباروری فرد 5-عدم اطمینان به اینکه بتواند در تمام جلسات مشاوره شرکت نماید
In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model, and the control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model, and the control group will not participate in the counseling session.
In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model, and the control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد. البته هردو گروه درمان روتین ناباروری خود را طبق نظر پزشک دریافت خواهند کرد
در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد.
در این مطالعه یک گروه به عنوان گروه مداخله، در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری شرکت خواهند کرد و گروه کنترل در جلسه مشاوره ای شرکت نخواهند کرد. البته هردو گروه درمان روتین ناباروری خود را طبق نظر پزشک دریافت خواهند کرد
General information
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After approval by the Research Council of the Tabriz Faculty of Nursing and Midwifery, the sampling center has been changed from Al-Zahra Tabriz Center to the Jahad Daneshgahi Infertility Center.
After approval by the Research Council of the Tabriz Faculty of Nursing and Midwifery, the sampling center has been changed from Al-Zahra Tabriz Center to the Jahad Daneshgahi Infertility Center.
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مرکز نمونه گیری بعد از تایید شورای پژوهشی دانشکده پرستاری و مامایی تبریز از مرکز الزهرا تبریز به مرکز ناباروری جهاد دانشگاهی تغییر یافته است.
مرکز نمونه گیری بعد از تایید شورای پژوهشی دانشکده پرستاری و مامایی تبریز از مرکز الزهرا تبریز به مرکز ناباروری جهاد دانشگاهی تغییر یافته است.
The effect of counseling with the method of happiness training on the stress of infertile women: a randomized controlled trial
The effect of counseling with the method of happiness training on the stress of infertile women
The effect of counseling with the method of happiness training on the stress of infertile women: a randomized controlled trial
تاثیر مشاوره با شیوه آموزش شادکامی بر استرس زنان نابارور: یک کارآزمایی تصادفی کنترل شده
تاثیر مشاوره با شیوه آموزش شادکامی بر استرس زنان نابارور
تاثیر مشاوره با شیوه آموزش شادکامی بر استرس زنان نابارور: یک کارآزمایی تصادفی کنترل شده
ابتلا به بیماری های اعصاب و روان بنا به گفته خود بیمار
ابتلا به بیماری های مزمن (نارسایی کلیه و کبد و......)
مصرف داروهای روان پزشکی بنا به اظهار خود بیمار
مراجعه به روانشناس طی چند ماه گذشته به علت ناباروری فرد
عدم اطمینان به اینکه بتواند در تمام جلسات مشاوره شرکت نماید
ابتلا به بیماری های اعصاب و روان بنا به گفته خود بیمار
ابتلا به بیماری های مزمن (نارسایی کلیه و کبد و...)
مصرف داروهای روان پزشکی بنا به اظهار خود بیمار
مراجعه به روانشناس طی چند ماه گذشته به علت ناباروری فرد
عدم اطمینان به اینکه بتواند در تمام جلسات مشاوره شرکت نماید
ابتلا به بیماری های اعصاب و روان بنا به گفته خود بیمار ابتلا به بیماری های مزمن (نارسایی کلیه و کبد و......) مصرف داروهای روان پزشکی بنا به اظهار خود بیمار مراجعه به روانشناس طی چند ماه گذشته به علت ناباروری فرد عدم اطمینان به اینکه بتواند در تمام جلسات مشاوره شرکت نماید
مشارکت¬کنندگانی که پرسشنامه¬های پیش¬آزمون را تکمیل کرده ¬باشند، به طور تصادفی و با استفاده از وب¬سایت www.random.org و ازطریق بلوک¬بندی با بلوک¬های چهار و شش تایی با نسبت تخصیص 1:1 به دو گروه مداخله ( دریافت کننده مشاوره) و گروه کنترل (عدم دریافت مشاوره) تخصیص داده خواهند شد.
مشارکت کنندگانی که پرسشنامه های پیش آزمون را تکمیل کرده باشند، به طور تصادفی و با استفاده از وب سایت www.random.org و ازطریق بلوک بندی با بلوک های چهار و شش تایی با نسبت تخصیص 1:1 به دو گروه مداخله (دریافت کننده مشاوره) و گروه کنترل (عدم دریافت مشاوره) تخصیص داده خواهند شد.
مشارکت¬کنندگانی که پرسشنامه¬های پیش¬آزمون را تکمیل کرده ¬باشند، به طور تصادفی و با استفاده از وب¬سایت www.random.org و ازطریق بلوک¬بندی با بلوک¬های چهار و شش تایی با نسبت تخصیص 1:1 به دو گروه مداخله (دریافت کننده مشاوره) و گروه کنترل (عدم دریافت مشاوره) تخصیص داده خواهند شد.
Health conditions studied
#1
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F40-F48
F40-F48
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Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Primary outcomes
#1
The Fertility problem Inventory(FPI)
The Fertility problem Inventory (FPI)
The Fertility problem Inventory(FPIInventory (FPI)
گروه مداخله: این گروه در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری طی 8 جلسه شرکت خواهند کرد
گروه مداخله: این گروه در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری طی 8 جلسه شرکت خواهند کرد.
گروه مداخله: این گروه در جلسات مشاوره با شیوه آموزش شادکامی مبتنی بر الگوی شناختی رفتاری طی 8 جلسه شرکت خواهند کرد.
#2
گروه کنترل: برای گروه کنترل جلسه مشاوره ای برگزار نخواهد شد
گروه کنترل: برای گروه کنترل جلسه مشاوره ای برگزار نخواهد شد.
گروه کنترل: برای گروه کنترل جلسه مشاوره ای برگزار نخواهد شد.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان آموزشی درمانی الزهرا
Name of recruitment center - Persian: Al-Zahra educational hospital
Full name of responsible person - English: خدیجه حاجی زاده
Full name of responsible person - Persian: Khadijeh Hajizadeh
Street address - English: Alzahra Hospital, Artesh street
Street address - Persian: خیابان ارتش، بیمارستان الزهرا
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3553 9161
Fax:
Email: nursing@tbzmed.ac.ir
Web page address:
Name of recruitment center - English: مرکز ناباروری جهاد دانشگاهی
Name of recruitment center - Persian: The infertility Center of Jahad Daneshgahi
Full name of responsible person - English: خدیجه حاجی زاده
Full name of responsible person - Persian: Khadijeh Hajizadeh
Street address - English: Jame Jam street
Street address - Persian: خیابان جام جم
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3329 5729
Fax:
Email: nursing@tbzmed.ac.ir
Web page address:
Name of recruitment center - English: بیمارستان آموزشی درمانی الزهرامرکز ناباروری جهاد دانشگاهی Name of recruitment center - Persian: Al-Zahra educational hospitalThe infertility Center of Jahad Daneshgahi Full name of responsible person - English: خدیجه حاجی زاده Full name of responsible person - Persian: Khadijeh Hajizadeh Street address - English: Alzahra Hospital, ArteshJame Jam street Street address - Persian: خیابان ارتش، بیمارستان الزهراجام جم City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5138947977 Phone: +98 41 3553 91613329 5729 Fax: Email: nursing@tbzmed.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fereshteh Shaker
Full name of responsible person - Persian: فرشته شاکر
Position - English: Student of master's degree in Counselling in Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مشاوره در مامایی
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati St
Street address - Persian: خیابان شریعتی جنوبی دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3447 2966
Mobile: +98 937 534 9616
Fax:
Email: Frsh319@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fereshteh Shaker
Full name of responsible person - Persian: فرشته شاکر
Position - English: Student of master's degree in Counselling in Midwifery
Position - Persian: دانشجوی کارشناسی ارشد مشاوره در مامایی
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati St
Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3447 2966
Mobile: +98 937 534 9616
Fax:
Email: Frsh319@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Fereshteh Shaker Full name of responsible person - Persian: فرشته شاکر Position - English: Student of master's degree in Counselling in Midwifery Position - Persian: دانشجوی کارشناسی ارشد مشاوره در مامایی Latest degree: bachelor Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Faculty of Nursing and Midwifery, South Shariati St Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138947977 Phone: +98 41 3447 2966 Mobile: +98 937 534 9616 Fax: Email: Frsh319@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Khadijeh Hajizadeh
Full name of responsible person - Persian: خدیجه حاجی زاده
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati Street
Street address - Persian: خیابان شریعتی جنوبی دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3447 2699
Mobile: +98 914 462 0846
Fax:
Email: hajizade_k@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Khadijeh Hajizadeh
Full name of responsible person - Persian: خدیجه حاجی زاده
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati Street
Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5138947977
Phone: +98 41 3447 2699
Mobile: +98 914 462 0846
Fax:
Email: hajizade_k@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Khadijeh Hajizadeh Full name of responsible person - Persian: خدیجه حاجی زاده Position - English: Assistant professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Faculty of Nursing and Midwifery, South Shariati Street Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5138947977 Phone: +98 41 3447 2699 Mobile: +98 914 462 0846 Fax: Email: hajizade_k@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fereshteh Shaker
Full name of responsible person - Persian: فرشته شاکر
Position - English: Student of master's degree in Counselling in midwifery
Position - Persian: دانشجوی کارشنارسی ارشد مشاوره در مامایی
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati Street
Street address - Persian: خیابان شریعتی جنوبی دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5415933739
Phone: +98 41 3447 2966
Mobile: +98 937 534 9616
Fax:
Email: Frsh319@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fereshteh Shaker
Full name of responsible person - Persian: فرشته شاکر
Position - English: Student of master's degree in Counselling in midwifery
Position - Persian: دانشجوی کارشنارسی ارشد مشاوره در مامایی
Latest degree: bachelor
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Nursing and Midwifery, South Shariati Street
Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5415933739
Phone: +98 41 3447 2966
Mobile: +98 937 534 9616
Fax:
Email: Frsh319@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Fereshteh Shaker Full name of responsible person - Persian: فرشته شاکر Position - English: Student of master's degree in Counselling in midwifery Position - Persian: دانشجوی کارشنارسی ارشد مشاوره در مامایی Latest degree: bachelor Area of specialty/work: 1 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Faculty of Nursing and Midwifery, South Shariati Street Street address - Persian: خیابان شریعتی جنوبی، دانشکده پرستاری و مامایی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5415933739 Phone: +98 41 3447 2966 Mobile: +98 937 534 9616 Fax: Email: Frsh319@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of counseling on the stress of infertile women will be done with the method of teaching happiness program based on cognitive behavioral model
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 60 infertile women. The stratified random block method will be used for randomization
Settings and conduct
The location of the research in this study is the infertility Center of Jahad Daneshgahi in Tabriz and the time of the research is 2024. In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model. The control group will not participate in the counseling session. Of course, both groups will receive their routine infertility treatment according to the doctor's opinion
Participants/Inclusion and exclusion criteria
Infertile women who will refer to the infertility Center of Jahad Daneshgahi in Tabriz for treatment
Inclusion criteria:
1- Infertile women with at least one year of primary infertility and undergoing IVF treatment
2- Having at least basic literacy
3- Obtaining a minimum score of 184 on the Infertility Stress Questionnaire
Exclusion criteria:
1- Suffering from neurological and mental illnesses according to the patient's own statement
2- Suffering from chronic illnesses (kidney and liver failure, etc.)
3- Taking psychiatric medications according to the patient's own statement
4- Referral to a psychologist within the past few months due to infertility
5- Lack of confidence in being able to attend all counseling sessions
Intervention groups
In this study, a group as an intervention group will participate in counseling sessions with the method of teaching happiness based on the cognitive behavioral model, and the control group will not participate in the counseling session.
Main outcome variables
Infertility stress score
General information
Reason for update
After approval by the Research Council of the Tabriz Faculty of Nursing and Midwifery, the sampling center has been changed from Al-Zahra Tabriz Center to the Jahad Daneshgahi Infertility Center.
Acronym
IRCT registration information
IRCT registration number:IRCT20240809062706N1
Registration date:2024-08-23, 1403/06/02
Registration timing:prospective
Last update:2025-11-12, 1404/08/21
Update count:1
Registration date
2024-08-23, 1403/06/02
Registrant information
Name
Khadije Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hajizade_k@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with the method of happiness training based on cognitive behavioral model on the stress of infertile women: a randomized controlled trial
Public title
The effect of counseling with the method of happiness training on the stress of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with at least one year of primary infertility and treated with IVF
Having at least middle school literacy
Obtaining a minimum score of 184 in the infertility stress questionnaire
Exclusion criteria:
Suffering from nervous and mental diseases according to the patient herself
Suffering from chronic diseases (kidney and liver failure, etc.)
Taking psychiatric drugs according to the patient's own statement
Visiting a psychologist in the past few months due to infertility
Uncertainty that she can participate in all counseling sessions
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
1
Infertile women who will refer to the infertility clinic of Al-Zahra Medical Training Center in Tabriz for treatment
Randomization (investigator's opinion)
Randomized
Randomization description
The participants who completed the pre-test questionnaires were randomly selected using the website www.random.org and by blocking with blocks of four and six with an allocation ratio of 1:1. They will be assigned to two intervention groups (receiving counseling) and control group (not receiving counseling).
Blinding (investigator's opinion)
Single blinded
Blinding description
The person supervising the completion of the post-test questionnaires, the outcome evaluator, and the data analyst will be a person not involved in sampling
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
IR.TBZMED.REC.1403.404
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
F40-F48
ICD-10 code description
Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Primary outcomes
1
Description
Average infertility stress score
Timepoint
Before and after the intervention
Method of measurement
The Fertility problem Inventory (FPI)
Secondary outcomes
1
Description
Average infertility self-efficacy score
Timepoint
Before and after the intervention
Method of measurement
Infertility self-efficacy scale (ISE)
Intervention groups
1
Description
Intervention group: This group will participate in counseling sessions with the method of teaching happiness based on the cognitive-behavioral model during 8 sessions
Category
Treatment - Other
2
Description
Control group: No counseling session will be held for the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز ناباروری جهاد دانشگاهی
Full name of responsible person
خدیجه حاجی زاده
Street address
Jame Jam street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3329 5729
Email
nursing@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Shaker
Position
Student of master's degree in Counselling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati St
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2966
Email
Frsh319@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khadijeh Hajizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3447 2699
Email
hajizade_k@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Shaker
Position
Student of master's degree in Counselling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 3447 2966
Email
Frsh319@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD