Effectiveness of educational package of psychological care during pregnancy based on mindfulness on pregnancy anxiety, mother-fetus attachment, psychological empowerment and marital satisfaction of pregnant womens
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Primiparous pregnant women who visit several obstetrician and gynecologist offices in District 1 of Mashhad Municipality will be selected purposively according to the study inclusion criteria and randomly assigned to two experimental and control groups. Pre-test, training, post-test, and follow-up will be conducted 45 days after the intervention
Primiparous pregnant women who refer to several obstetrician and gynecologist offices in District 1 of Mashhad Municipality and are selected and randomly assigned to two experimental and control groups based on the study inclusion criteria. Pre-test, training, post-test, and follow-up will be conducted 45 days after the intervention.
Primiparous pregnant women who visitrefer to several obstetrician and gynecologist offices in District 1 of Mashhad Municipality will beand are selected purposively according to the study inclusion criteria and randomly assigned to two experimental and control groups based on the study inclusion criteria. Pre-test, training, post-test, and follow-up will be conducted 45 days after the intervention.
زنان باردار نخست زايي که به چند مطب مامایی و متخصص زنان در منطقه 1 شهرداری مشهد مراجعه مي نمايند و به صورت هدفمند، با توجه به معيارهاي ورود مطالعه؛ انتخاب مي شوند و بصورت تصادفی در دو گروه آزمايش و کنترل قرار مي گيرند. پيش آزمون، آموزش، پس آزمون و پيگيري 45 روز بعد از اتمام مداخله اجرا خواهد شد.
زنان باردار نخست زايي که به چند مطب مامایی و متخصص زنان در منطقه 1 شهرداری مشهد مراجعه و به صورت نمونه گیری در دسترس، با توجه به معيارهاي ورود مطالعه؛ انتخاب و تصادفی در دو گروه آزمايش و کنترل قرار مي گيرند. پيش آزمون، آموزش، پس آزمون و پيگيري 45 روز بعد از اتمام مداخله اجرا خواهد شد.
زنان باردار نخست زايي که به چند مطب مامایی و متخصص زنان در منطقه 1 شهرداری مشهد مراجعه مي نمايند و به صورت هدفمندنمونه گیری در دسترس، با توجه به معيارهاي ورود مطالعه؛ انتخاب مي شوند و بصورت تصادفی در دو گروه آزمايش و کنترل قرار مي گيرند. پيش آزمون، آموزش، پس آزمون و پيگيري 45 روز بعد از اتمام مداخله اجرا خواهد شد.
Intervention group: The mindfulness-based prenatal psychological care educational package developed by the researcher will be held for primiparous pregnant women during 9 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions on mental health and psychological care during pregnancy is based on mindful pregnancy for better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment.
Control group: In order to observe ethics in research, after the end of intervention, two educational sessions will be received
Intervention group: The mindfulness-based prenatal psychological care educational package developed by the researcher will be held for primiparous pregnant women during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions on mental health and psychological care during pregnancy is based on mindful pregnancy for better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment.
Control group: In order to observe ethics in research, after the end of intervention, two educational sessions will be received
Intervention group: The mindfulness-based prenatal psychological care educational package developed by the researcher will be held for primiparous pregnant women during 98 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions on mental health and psychological care during pregnancy is based on mindful pregnancy for better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. Control group: In order to observe ethics in research, after the end of intervention, two educational sessions will be received
گروه مداخله: بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، برای زنان باردار نخست زا طی 9 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه برگزار خواهد شد. محتواي جلسات پيرامون بهداشت روانی و مراقبتهاي روان شناختي دوران بارداری مبتنی بر بارداري ذهن آگاهانه به جهت مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند.
گروه کنترل: به منظور رعایت اخلاق در پژوهش، پس از اتمام مداخله دو جلسه آموزشی دریافت خواهند کرد
گروه مداخله: بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، برای زنان باردار نخست زا طی 8 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه برگزار خواهد شد. محتواي جلسات پيرامون بهداشت روانی و مراقبتهاي روان شناختي دوران بارداری مبتنی بر بارداري ذهن آگاهانه به جهت مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند.
گروه کنترل: به منظور رعایت اخلاق در پژوهش، پس از اتمام مداخله دو جلسه آموزشی دریافت خواهند کرد
گروه مداخله: بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، برای زنان باردار نخست زا طی 98 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه برگزار خواهد شد. محتواي جلسات پيرامون بهداشت روانی و مراقبتهاي روان شناختي دوران بارداری مبتنی بر بارداري ذهن آگاهانه به جهت مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند. گروه کنترل: به منظور رعایت اخلاق در پژوهش، پس از اتمام مداخله دو جلسه آموزشی دریافت خواهند کرد
Intervention groups
#1
Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 9 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness 2) Mindful connection with the body and acceptance of physical and mental changes 3) Mindful management of stress and anxiety 4) Management of thoughts and emotions 5) Mindful communication with the fetus 6) Mindful supportive and marital relationships 7) Mindful management of pain and physical discomfort 8) Preparation for a mindful birth 9) Planning for the postpartum period
Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness and self-awareness during pregnancy 2) Body awareness, acceptance of the pregnancy experience, and connection with the fetus 3) Stress, anxiety, and emotion regulation management 4) Self-compassion, self-care, and reduction of rumination 5) Mindfulness in relationships, social support, and couple communication 6) Psychological preparation for childbirth and conscious exposure to pain 7) Mindfulness in parenting, newborn care, and the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice
Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 98 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness and self-awareness during pregnancy 2) MindfulBody awareness, acceptance of the pregnancy experience, and connection with the body and acceptance of physical and mental changesfetus 3) Mindful management of stressStress, anxiety, and anxietyemotion regulation management 4) ManagementSelf-compassion, self-care, and reduction of thoughts and emotionsrumination 5) MindfulMindfulness in relationships, social support, and couple communication with the fetus 6) Mindful supportivePsychological preparation for childbirth and marital relationshipsconscious exposure to pain 7) Mindful management of painMindfulness in parenting, newborn care, and physical discomfort 8) Preparation for a mindful birth 9) Planning for the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice
گروه مداخله: زنان باردار نخست زا تحت مداخله بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، طی 9 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه قرار خواهند گرفت. محتواي جلسات در ارتباط با کسب اطلاعات پيرامون بهداشت روانی و مراقبتهاي روان شناختي با داشتن يک بارداري ذهن آگاهانه و انجام تمرينات ذهن آگاهي براي کسب آرامش و مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند. خلاصه محتواي هر جلسه به شرح زیر است: 1) آشنايي با ذهن آگاهی 2) ارتباط ذهن آگاهانه با بدن و پذیرش تغییرات جسمی و روانی 3) مدیریت ذهن آگاهانه استرس و اضطراب 4) مدیریت افکار و احساسات 5) برقراری ارتباط ذهن آگاهانه با جنین 6) روابط حمایتی و زناشویی ذهن آگاهانه 7) مدیریت ذهن آگاهانه درد و ناراحتی های جسمی 8) اماده سازی برای یک تولد ذهن آگاهانه 9) برنامه ریزی برای دوران پس از زایمان
گروه مداخله: زنان باردار نخست زا تحت مداخله بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، طی 8 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه قرار خواهند گرفت. محتواي جلسات در ارتباط با کسب اطلاعات پيرامون بهداشت روانی و مراقبتهاي روان شناختي با داشتن يک بارداري ذهن آگاهانه و انجام تمرينات ذهن آگاهي براي کسب آرامش و مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند. خلاصه محتواي هر جلسه به شرح زیر است: 1) آشنایی با ذهن آگاهی و خود آگاهی در دوران بارداری 2) آگاهی از بدن، پذیرش تجربه بارداری و ارتباط با جنین 3) مدیریت استرس، اضطراب و تنظیم هیجان 4) شفقت به خود، خودمراقبتی و کاهش نشخوار ذهنی 5) ذهن آگاهی در روابط، حمایت اجتماعی و ارتباط زوجین 6) آمادگی روان شناختی برای زایمان و مواجهه آگاهانه با درد 7) ذهن آگاهی در والدگری، مراقبت از نوزاد و دوران پس از زایمان 8) جمع بندی، تثبیت مهارت ها و برنامه استمرار تمرین
گروه مداخله: زنان باردار نخست زا تحت مداخله بسته آموزشی مراقبتهاي روان شناختي دوران بارداري مبتني بر ذهن آگاهي که محقق ساخته است، طی 98 جلسه 90 دقیقه ای (هفته ای دو جلسه) به مدت 1 ماه قرار خواهند گرفت. محتواي جلسات در ارتباط با کسب اطلاعات پيرامون بهداشت روانی و مراقبتهاي روان شناختي با داشتن يک بارداري ذهن آگاهانه و انجام تمرينات ذهن آگاهي براي کسب آرامش و مديريت بهتر اين دوران مي باشد. ذهن آگاهی با هدف تمرکز بر حضور در لحظه حال و آگاه شدن از افکار، احساسات و تجربیات بدون قضاوت به افراد کمک می کند تا با استرس و اضطراب کمتری زندگی کنند. خلاصه محتواي هر جلسه به شرح زیر است: 1) آشناييآشنایی با ذهن آگاهی و خود آگاهی در دوران بارداری 2) آگاهی از بدن، پذیرش تجربه بارداری و ارتباط ذهن آگاهانه با بدن و پذیرش تغییرات جسمی و روانیجنین 3) مدیریت ذهن آگاهانه استرس، اضطراب و اضطرابتنظیم هیجان 4) مدیریت افکارشفقت به خود، خودمراقبتی و احساساتکاهش نشخوار ذهنی 5) برقراریذهن آگاهی در روابط، حمایت اجتماعی و ارتباط ذهنزوجین 6) آمادگی روان شناختی برای زایمان و مواجهه آگاهانه با جنین 6) روابط حمایتی و زناشویی ذهن آگاهانهدرد 7) مدیریت ذهن آگاهانه دردآگاهی در والدگری، مراقبت از نوزاد و ناراحتی های جسمی 8) اماده سازی برای یک تولد ذهن آگاهانه 9) برنامه ریزی برای دوران پس از زایمان 8) جمع بندی، تثبیت مهارت ها و برنامه استمرار تمرین
Recruitment centers
#1
Name of recruitment center - English: Healthcare centers
Name of recruitment center - Persian: مراکز بهداشتي درماني
Full name of responsible person - English: narges zarei
Full name of responsible person - Persian: نرگس زارعي
Street address - English: between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
Street address - Persian: بلوار شهيد قاضي طباطبايي، بين قاضي طباطبايي 14 و 16
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 915 400 7017
Fax:
Email: nargeszarei57@yahoo.com
Web page address:
Name of recruitment center - English: Maternity clinic
Name of recruitment center - Persian: کلینیک مادرانه
Full name of responsible person - English: Maryam Grigoryan
Full name of responsible person - Persian: مریم گریگوریان
Street address - English: Unit 4, Second Floor, Platinum Building 2, Kohsangi 8
Street address - Persian: کوهسنگی ۸، ساختمان پلاتینیوم ۲، طبقه دوم، واحد ۴
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 939 526 5359
Fax:
Email: Maryam.griguriyan@gmail.com
Web page address:
Name of recruitment center - English: Healthcare centersMaternity clinic Name of recruitment center - Persian: مراکز بهداشتي درمانيکلینیک مادرانه Full name of responsible person - English: narges zareiMaryam Grigoryan Full name of responsible person - Persian: نرگس زارعيمریم گریگوریان Street address - English: between Qazi Tabatabaei 14 and 16Unit 4, Shahid Qazi Tabatabaei BoulevardSecond Floor, Platinum Building 2, Kohsangi 8 Street address - Persian: بلوار شهيد قاضي طباطباييکوهسنگی ۸، بين قاضي طباطبايي 14 و 16ساختمان پلاتینیوم ۲، طبقه دوم، واحد ۴ City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9184983765 Phone: +98 915 400 7017939 526 5359 Fax: Email: nargeszarei57Maryam.griguriyan@yahoo.comgmail.com Web page address:
#2
Name of recruitment center - English: Mothers' Paradise Midwifery Consulting Center
Name of recruitment center - Persian: مرکز مشاوره مامایی بهشت مادران
Full name of responsible person - English: Maryam Bazshad
Full name of responsible person - Persian: مریم بازشاد
Street address - English: Third floor- Iranian Building- Kohsangi 8
Street address - Persian: کوهسنگی ۸، ساختمان ایرانیان، طبقه سوم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 915 559 5377
Fax:
Email: nargeszarei57@yahoo.com
Web page address:
Name of recruitment center - English: Mothers' Paradise Midwifery Consulting Center
Name of recruitment center - Persian: مرکز مشاوره مامایی بهشت مادران
Full name of responsible person - English: Maryam Bazshad
Full name of responsible person - Persian: مریم بازشاد
Street address - English: Third floor, Iranian Building, Kohsangi 8
Street address - Persian: کوهسنگی ۸، ساختمان ایرانیان، طبقه سوم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 915 559 5377
Fax:
Email: mbazshad@gmail.com
Web page address:
Name of recruitment center - English: Mothers' Paradise Midwifery Consulting Center Name of recruitment center - Persian: مرکز مشاوره مامایی بهشت مادران Full name of responsible person - English: Maryam Bazshad Full name of responsible person - Persian: مریم بازشاد Street address - English: Third floor-, Iranian Building-, Kohsangi 8 Street address - Persian: کوهسنگی ۸، ساختمان ایرانیان، طبقه سوم City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9184983765 Phone: +98 915 559 5377 Fax: Email: nargeszarei57mbazshad@yahoo.comgmail.com Web page address:
#3
Name of recruitment center - English: Gynecologist's office of Dr. Zahra Mohsenian
Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر زهرا محسنیان
Full name of responsible person - English: Zahra Mohsenian
Full name of responsible person - Persian: زهرا محسنیان
Street address - English: Fourth Floor- Sina Doctors Building- Aref Street 2
Street address - Persian: خیابان عارف 2، ساختمان پزشکان سما، طبقه چهارم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 915 312 6470
Fax:
Email: nargeszarei57@yahoo.com
Web page address:
Name of recruitment center - English: Gynecologist's office of Dr. Zahra Mohsenian
Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر زهرا محسنیان
Full name of responsible person - English: Zahra Mohsenian
Full name of responsible person - Persian: زهرا محسنیان
Street address - English: Fourth Floor, Sina Doctors Building, Aref Street 2
Street address - Persian: خیابان عارف 2، ساختمان پزشکان سما، طبقه چهارم
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 915 312 6470
Fax:
Email: Mohsenian@yahoo.com
Web page address:
Name of recruitment center - English: Gynecologist's office of Dr. Zahra Mohsenian Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر زهرا محسنیان Full name of responsible person - English: Zahra Mohsenian Full name of responsible person - Persian: زهرا محسنیان Street address - English: Fourth Floor-, Sina Doctors Building-, Aref Street 2 Street address - Persian: خیابان عارف 2، ساختمان پزشکان سما، طبقه چهارم City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9184983765 Phone: +98 915 312 6470 Fax: Email: nargeszarei57Mohsenian@yahoo.com Web page address:
#4
Name of recruitment center - English: Gynecologist's office of Dr. Parisa Najafi
Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر پریسا نجفی
Full name of responsible person - English: Parisa Najafi
Full name of responsible person - Persian: پریسا نجفی
Street address - English: Nikan Building- Aref Street 2
Street address - Persian: خیابان عارف 2، ساختمان نیکان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 51 3846 0217
Fax:
Email: nargeszarei57@yahoo.com
Web page address:
Name of recruitment center - English: Gynecologist's office of Dr. Parisa Najafi
Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر پریسا نجفی
Full name of responsible person - English: Parisa Najafi
Full name of responsible person - Persian: پریسا نجفی
Street address - English: Nikan Building, Aref Street 2
Street address - Persian: خیابان عارف 2، ساختمان نیکان
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9184983765
Phone: +98 51 3846 0217
Fax:
Email: Parisa.najafi_n@yahoo.com
Web page address:
Name of recruitment center - English: Gynecologist's office of Dr. Parisa Najafi Name of recruitment center - Persian: مطب متخصص زنان خانم دکتر پریسا نجفی Full name of responsible person - English: Parisa Najafi Full name of responsible person - Persian: پریسا نجفی Street address - English: Nikan Building-, Aref Street 2 Street address - Persian: خیابان عارف 2، ساختمان نیکان City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9184983765 Phone: +98 51 3846 0217 Fax: Email: nargeszarei57Parisa.najafi_n@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: narges zarei
Full name of responsible person - Persian: نرگس زارعي
Street address - English: Mohammadiyeh 23, Islamic Azad University
Street address - Persian: محمديه 23 ، دانشگاه آزاد اسلامي
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9187147578
Phone: +98 915 400 7017
Fax:
Email: mashhad@iau.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mitra Zeratpisheh
Full name of responsible person - Persian: میترا زراعت پیشه
Street address - English: Islamic Azad University, Mohammadiyeh 23, Mohammadiyeh Blvd., Qasemabad
Street address - Persian: قاسم آباد، بلوار محمدیه، محمدیه 23، دانشگاه آزاد اسلامی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9187147578
Phone: +98 51 3524 6891
Fax:
Email: 369789@iau.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: narges zareiMitra Zeratpisheh Full name of responsible person - Persian: نرگس زارعيمیترا زراعت پیشه Street address - English: Islamic Azad University, Mohammadiyeh 23, Islamic Azad UniversityMohammadiyeh Blvd., Qasemabad Street address - Persian: محمديهقاسم آباد، بلوار محمدیه، محمدیه 23، دانشگاه آزاد اسلامياسلامی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9187147578 Phone: +98 915 400 701751 3524 6891 Fax: Email: mashhad369789@iau.ac.iriau.ir Web page address:
Protocol summary
Study aim
To investigate the effectiveness of a mindfulness-based educational package for psychological care during pregnancy on pregnancy anxiety, mother-fetus attachment, psychological empowerment, and marital satisfaction
Design
Clinical trial with control group, with parallel groups, randomized and without blinding on 40 pregnant women
Settings and conduct
Primiparous pregnant women who refer to several obstetrician and gynecologist offices in District 1 of Mashhad Municipality and are selected and randomly assigned to two experimental and control groups based on the study inclusion criteria. Pre-test, training, post-test, and follow-up will be conducted 45 days after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged Between 20 to 35 years, The first pregnancy, between 2nd to 6th month of pregnancy, informed consent, no addiction, no psychiatric disorders, no medical and obstetric problems, no mental crisis
Exclusion criteria: The presence of obvious fetal abnormalities, Unwillingness or inability to participate in sessions
Intervention groups
Intervention group: The mindfulness-based prenatal psychological care educational package developed by the researcher will be held for primiparous pregnant women during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions on mental health and psychological care during pregnancy is based on mindful pregnancy for better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment.
Control group: In order to observe ethics in research, after the end of intervention, two educational sessions will be received
Effectiveness of educational package of psychological care during pregnancy based on mindfulness on pregnancy anxiety, mother-fetus attachment, psychological empowerment and marital satisfaction of pregnant womens
Public title
Investigating the effect of educational package of psychological care during pregnancy based on mindfulness on pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 20 to 35 years
The first pregnancy
Being between the 2nd to 6th month of pregnancy
Having at least a high school diploma
Residing in Mashhad city
Desired pregnancy
Informed consent to participate in the research
No addiction and not being treated for psychiatric disorders
No medical and obstetric problems based on medical records (diabetes, blood pressure, previous miscarriage, etc.)
No mental crisis such as separation and death of loved ones during the 6 months prior to the research
No attendance at yoga and meditation classes
Exclusion criteria:
The presence of obvious fetal abnormalities
Unwillingness or inability to participate in sessions
Having other medical and psychiatric disorders
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be based on a simple random method. Therefore, a random number is assigned to each patient by the table of random numbers, according to which if the number is odd, the patient will be in the intervention group, and if it is an even number, the patient will be in the control group
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
Ethics Committee of the Faculty of Medicine, Islamic Azad University
Street address
Faculty of Medicine, Mashhad Azad University, No 47, Sarab Bazarche, 14 Imam Khomeini
City
Mashhad
Province
Razavi Khorasan
Postal code
9133736351
Approval date
2025-04-16, 1404/01/27
Ethics committee reference number
IR.IAU.MSHD.REC.1404.018
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34.8
ICD-10 code description
Supervision of other normal pregnancy
Primary outcomes
1
Description
Pregnancy Anxiety
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
The Vandenberg Pregnancy Related Anxiety Questionnaire
2
Description
Mother-Fetus Attachment
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
The Cranly Mother-Fetus Attachment Questionnaire
3
Description
Psychological Empowerment
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
Kameda’s Prenatal Psychological Empowerment Scale
4
Description
Marital Satisfaction
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
Enrich Marital Satisfaction Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 8 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness and self-awareness during pregnancy 2) Body awareness, acceptance of the pregnancy experience, and connection with the fetus 3) Stress, anxiety, and emotion regulation management 4) Self-compassion, self-care, and reduction of rumination 5) Mindfulness in relationships, social support, and couple communication 6) Psychological preparation for childbirth and conscious exposure to pain 7) Mindfulness in parenting, newborn care, and the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice
Category
Treatment - Other
2
Description
Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two educational sessions will be provided for this group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity clinic
Full name of responsible person
Maryam Grigoryan
Street address
Unit 4, Second Floor, Platinum Building 2, Kohsangi 8
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 939 526 5359
Email
Maryam.griguriyan@gmail.com
2
Recruitment center
Name of recruitment center
Mothers' Paradise Midwifery Consulting Center
Full name of responsible person
Maryam Bazshad
Street address
Third floor, Iranian Building, Kohsangi 8
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 915 559 5377
Email
mbazshad@gmail.com
3
Recruitment center
Name of recruitment center
Gynecologist's office of Dr. Zahra Mohsenian
Full name of responsible person
Zahra Mohsenian
Street address
Fourth Floor, Sina Doctors Building, Aref Street 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 915 312 6470
Email
Mohsenian@yahoo.com
4
Recruitment center
Name of recruitment center
Gynecologist's office of Dr. Parisa Najafi
Full name of responsible person
Parisa Najafi
Street address
Nikan Building, Aref Street 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3846 0217
Email
Parisa.najafi_n@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mitra Zeratpisheh
Street address
Islamic Azad University, Mohammadiyeh 23, Mohammadiyeh Blvd., Qasemabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 51 3524 6891
Email
369789@iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Mashhad Branch
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
Islamic Azad University
Full name of responsible person
Narges Zarei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3726 3725
Email
nargeszarei57@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Rajaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Mohammadiyeh 23, Mohammadiyeh Blvd., Qasem abad
City
Mashsad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 915 580 3467
Email
rajaei.46@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Zarei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
City
Mashsad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3726 3725
Email
nargeszarei57@yahoo.com
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
No - There is not 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