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چکیده پروتکل
Assess the Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women
Evaluate the effectiveness of a psychoeducational intervention on self-reported perceived physical and psychological immunity, health-promoting behaviors, personal control, stress, and fatigue among working women.
AssessEvaluate the Effecteffectiveness of Psychoeducational Intervention about Immune Healtha psychoeducational intervention on Perceived Physicalself-reported perceived physical and Psychological Health Among Working Womenpsychological immunity, health-promoting behaviors, personal control, stress, and fatigue among working women.
A randomized controlled trial, single-blind, case and control groups, pre-post intervention measurement.
An open-label, two-arm, parallel-group randomized controlled trial with blinded statistical analysis
AAn open-label, two-arm, parallel-group randomized controlled trial, single-blind, case and control groups, pre-post intervention measurement. with blinded statistical analysis
It will be conducted in five colleges affiliated with Damanhour University, Egypt.
Three colleges affiliated with Damanhour University, Egypt.
It will be conducted in fiveThree colleges affiliated with Damanhour University, Egypt.
Physical health: participants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales.
Psychological health: participants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.
Participants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales.
Participants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.
Physical health: participantsParticipants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales. Psychological health: participantsParticipants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.
اطلاعات عمومی
خالی
60
60
خالی
سال
year
بلی
خیر
1
یک سویه کور
کور نشده است
singlnotbl
1
1
1
1
172
160
172160
2023-12-01, ۱۴۰۲/۰۹/۱۰
2024-07-01, ۱۴۰۳/۰۴/۱۱
20232024-1207-01 00:00:00
2023-12-30, ۱۴۰۲/۱۰/۰۹
2024-07-30, ۱۴۰۳/۰۵/۰۹
20232024-1207-30 00:00:00
خالی
This update is requested to align the registry record with the final study protocol and the manuscript for publication. Specifically, we are updating the revised title statement requested by the journal, the target sample size to 160 to reflect our final sample size calculation (accounting for a 20% attrition rate), and the recruitment start date to July 2024 to reflect the actual timeline of the study. In addition, we are updating the ethical approval number and date and correcting the blinding status to 'Open label with blinded statistical analysis' to accurately reflect the trial design described in the manuscript.
This update is requested to align the registry record with the final study protocol and the manuscript for publication. Specifically, we are updating the revised title statement requested by the journal, the target sample size to 160 to reflect our final sample size calculation (accounting for a 20% attrition rate), and the recruitment start date to July 2024 to reflect the actual timeline of the study. In addition, we are updating the ethical approval number and date and correcting the blinding status to 'Open label with blinded statistical analysis' to accurately reflect the trial design described in the manuscript.
Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University: A Randomized Controlled Trial
Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial
EffectEffects of a Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological HealthImmunity, Stress, and Fatigue Among Working Women at Damanhour University: AAn Open-Label Randomized Controlled Trial
Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University/Egypt: A Randomized Controlled Trial
Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial
EffectEffects of a Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological HealthImmunity, Stress, and Fatigue Among Working Women at Damanhour University/Egypt: AAn Open-Label Randomized Controlled Trial
Adult women working in the selected colleges for at least one year before initiating the study
Adult women (20 years or more)
working in the selected colleges for at least one year before initiating the study
Access to a smartphone with WhatsApp
Ability to read and understand Arabic
Adult women (20 years or more) working in the selected colleges for at least one year before initiating the study Access to a smartphone with WhatsApp Ability to read and understand Arabic
Unwillingness to participate in this study
Unwillingness to participate in this study
Participation in another structured educational or psychological program during the study period
Severe psychiatric illness requiring ongoing specialized treatment (as self-reported)
Inability to attend the scheduled intervention sessions.
Unwillingness to participate in this study Participation in another structured educational or psychological program during the study period Severe psychiatric illness requiring ongoing specialized treatment (as self-reported) Inability to attend the scheduled intervention sessions.
خالی
The target group for this study will be women working in the selected colleges. They were selected using a cluster sampling technique (five colleges).
- A purposive sample of five colleges from Damanhour University will be selected based on having the highest number of female workers (Education, nursing, commerce, literature, and agriculture colleges) according to the latest data available from the university statistical center.
- A list will be created with the whole eligible female workers.
- The lottery system will be deployed by placing all the workers' names in a hat and then randomly selecting our sample without looking.
-Seventy percent of the female workers from each college will be recruited using the proportional allocation technique.
- Then they will be equally and randomly assigned to the intervention and comparison groups using a simple random method (Lottery method).
A purposive selection of three colleges will be made based on their high number of female employees. Eligible participants from these colleges will be assigned identification numbers. A computer-generated random number sequence will be used to randomly allocate participants to either the intervention or control group in a 1:1 ratio. Allocation concealment will be ensured by using sealed, opaque, sequentially numbered envelopes prepared by an independent researcher not involved in participant recruitment or data collection. Each envelope will be opened sequentially only after a participant has provided informed consent, completed the baseline assessment, and been enrolled, minimizing the risk of selection bias.
The target group for this studyA purposive selection of three colleges will be women working in the selected colleges. They were selected using a cluster sampling technique (five colleges). - A purposive sample of five colleges from Damanhour University will be selectedmade based on having the highesttheir high number of female workers (Education, nursing, commerce, literature, and agriculture colleges) according to the latest data availableemployees. Eligible participants from the university statistical center. - A listthese colleges will be created with the whole eligible female workersassigned identification numbers. A computer- The lottery systemgenerated random number sequence will be deployed by placing allused to randomly allocate participants to either the workers' namesintervention or control group in a hat and then randomly selecting our sample without looking1:1 ratio. -Seventy percent of the female workers from each collegeAllocation concealment will be recruitedensured by using the proportional allocation techniquesealed, opaque, sequentially numbered envelopes prepared by an independent researcher not involved in participant recruitment or data collection. - Then theyEach envelope will be equallyopened sequentially only after a participant has provided informed consent, completed the baseline assessment, and randomly assigned tobeen enrolled, minimizing the intervention and comparison groups using a simple random method (Lottery method)risk of selection bias.
The investigator who conducted the statistical analysis will not engaged in the overall data collection process. The investigators who will collect the data enter them into the SPSS program using hidden codes from the analyzer. After finishing the data analysis process using predetermined codes, they will contacted to interpret the codes of both groups: intervention group "A" and comparison group "B."
The investigator who conducted the statistical analysis will not engaged in the overall data collection process. The investigators who will collect the data enter them into the SPSS program using hidden codes from the analyzer. After finishing the data analysis process using predetermined codes, they will contacted to interpret the codes of both groups: intervention group "A" and comparison group "B."
خالی
تاییدیه کمیتههای اخلاق
#1
2023-11-10, ۱۴۰۲/۰۸/۱۹
2023-06-23, ۱۴۰۲/۰۴/۰۲
2023-1106-1023 00:00:00
10-11-01-2023 EC
101-d-23-6-2023
10101-11d-0123-6-2023 EC
گروههای مداخله
#1
Intervention group: composed of 88 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 40-50 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital supporting, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be accomplished after 3 months (posttest to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results.
Intervention group: composed of 80 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 30-40 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital support, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be conducted after 3 months (posttest) to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results.
Intervention group: composed of 8880 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 30-40-50 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital supportingsupport, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be accomplishedconducted after 3 months (posttest) to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results.
#2
Control group: They will be 88 women who will receive nothing. They initially will complete the pre-test and then the post-tests after 3 months, identically to the intervention group. In the end, they will receive the same educational content and assisted materials to preserve their moral and ethical rights and extend the benefits.
Control group: They will be 80 women who will receive nothing. They initially will complete the pre-test and then the post-test after 3 months, identically to the intervention group. At the end, they will receive the same educational content and support materials to preserve their moral and ethical rights and extend the benefits.
Control group: They will be 8880 women who will receive nothing. They initially will complete the pre-test and then the post-teststest after 3 months, identically to the intervention group. InAt the end, they will receive the same educational content and assistedsupport materials to preserve their moral and ethical rights and extend the benefits.
مراکز بیمار گیری
#1
نام مرکز بیمار گیری - انگلیسی: Five colleges affiliated with Damanhour university Egypt
نام مرکز بیمار گیری - فارسی:
نام کامل فرد مسوول - انگلیسی: Samiha Hamdi Sayed Ramadan
نام کامل فرد مسوول - فارسی:
آدرس خیابان - انگلیسی: Damanhour, Elbehira, Governorate, Egypt
آدرس خیابان - فارسی:
شهر - انگلیسی: Damahour
شهر - فارسی:
استان:
کشور: مصر
کد پستی: 22511
تلفن: +20 45 3311679
فکس:
ایمیل: samihareda93@gmail.com
آدرس صفحه وب:
نام مرکز بیمار گیری - انگلیسی: Three colleges affiliated with Damanhour university Egypt
نام مرکز بیمار گیری - فارسی:
نام کامل فرد مسوول - انگلیسی: Samiha Hamdi Sayed Ramadan
نام کامل فرد مسوول - فارسی:
آدرس خیابان - انگلیسی: Damanhour, Elbehira, Governorate, Egypt
آدرس خیابان - فارسی:
شهر - انگلیسی: Damahour
شهر - فارسی:
استان:
کشور: مصر
کد پستی: 22511
تلفن: +20 45 3311679
فکس:
ایمیل: samihareda93@gmail.com
آدرس صفحه وب:
نام مرکز بیمار گیری - انگلیسی: FiveThree colleges affiliated with Damanhour university Egypt نام مرکز بیمار گیری - فارسی: نام کامل فرد مسوول - انگلیسی: Samiha Hamdi Sayed Ramadan نام کامل فرد مسوول - فارسی: آدرس خیابان - انگلیسی: Damanhour, Elbehira, Governorate, Egypt آدرس خیابان - فارسی: شهر - انگلیسی: Damahour شهر - فارسی: استان: کشور: مصر کد پستی: 22511 تلفن: +20 45 3311679 فکس: ایمیل: samihareda93@gmail.com آدرس صفحه وب:
برنامه انتشار
undecided
yes
undecidedyes
yes
undecided
yesundecided
After publication and will be available long life
After publication, it will be available for 5 years
After publication and, it will be available long lifefor 5 years
None
Contacting the corresponding author
NoneContacting the corresponding author
چکیده پروتکل
هدف ازمطالعه
طراحی
نحوه و محل انجام مطالعه
شرکت کنندگان/شرایط ورود و عدم ورود
گروههای مداخله
متغیرهای پیامد اصلی
اطلاعات عمومی
علت بروز رسانی
نام اختصاری
اطلاعات ثبت در مرکز
شماره ثبت کارآزمایی در مرکز:IRCT20210612051555N5
تاریخ تایید ثبت در مرکز:2023-12-30, ۱۴۰۲/۱۰/۰۹
زمانبندی ثبت:prospective
آخرین بروز رسانی:2026-09-17, ۱۴۰۵/۰۶/۲۶
تعداد بروز رسانیها:1
تاریخ تایید ثبت در مرکز
2023-12-30, ۱۴۰۲/۱۰/۰۹
اطلاعات تماس ثبت کننده
نام
نام سازمان / نهاد
کشور
مصر
تلفن
+20 45 3538264
آدرس ایمیل
samihareda93@gmail.com
وضعیت بیمار گیری
بیمار گیری تمام شده
منبع مالی
تاریخ شروع بیمار گیری مورد انتظار
2024-07-01, ۱۴۰۳/۰۴/۱۱
تاریخ پایان بیمار گیری مورد انتظار
2024-07-30, ۱۴۰۳/۰۵/۰۹
تاریخ شروع بیمارگیری تحقق یافته
خالی
تاریخ پایان بیمارگیری تحقق یافته
خالی
تاریخ خاتمه کارآزمایی
خالی
عنوان علمی کارآزمایی
عنوان عمومی کارآزمایی
هدف اصلی مطالعه
آموزشی/مشاورهای
شرایط عمده ورود و عدم ورود به مطالعه
سن
از سن 20 ساله تا سن 60 ساله
جنسیت
مونث
فاز مطالعه
مصداق ندارد
گروههای کور شده در مطالعه
اطلاعات موجود نیست
حجم نمونه کل
حجم نمونه پیشبینی شده:
160
تصادفی سازی (نظر محقق)
اختصاص تصادفی به گروههای مداخله و کنترل
توصیف نحوه تصادفی سازی
کور سازی (به نظر محقق)
کور نشده است
توصیف نحوه کور سازی
دارو نما
ندارد
اختصاص به گروههای مطالعه
موازی
سایر مشخصات طراحی مطالعه
کد ثبت در سایر مراکز ثبت بینالمللی
خالی
تاییدیه کمیتههای اخلاق
1
کمیته اخلاق
نام کمیته اخلاق
آدرس خیابان
شهر
کد پستی
22511
تاریخ تایید
2023-06-23, ۱۴۰۲/۰۴/۰۲
کد کمیته اخلاق
101-d-23-6-2023
بیماریهای (موضوعات) مورد مطالعه
1
شرح
کد ICD-10
F43.8
توصیف کد ICD-10
Other reactions to severe stress
متغیر پیامد اولیه
1
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
2
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
3
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
4
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
5
شرح متغیر پیامد
مقاطع زمانی اندازهگیری
نحوه اندازهگیری متغیر
متغیر پیامد ثانویه
خالی
گروههای مداخله
1
شرح مداخله
گروه مداخله:
طبقه بندی
رفتاری
2
شرح مداخله
گروه کنترل:
طبقه بندی
غیره
مراکز بیمار گیری
1
مرکز بیمار گیری
نام مرکز بیمار گیری
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
22511
تلفن
+20 45 3311679
ایمیل
samihareda93@gmail.com
حمایت کنندگان / منابع مالی
1
حمایت کننده مالی
نام سازمان / نهاد
نام کامل فرد مسوول
آدرس خیابان
شهر
کد پستی
22511
تلفن
+20 45 3311679
ایمیل
samihareda93@gmail.com
ردیف بودجه
کد بودجه
آیا منبع مالی همان سازمان یا نهاد حمایت کننده مالی است؟
بلی
عنوان منبع مالی
درصد تامین مالی مطالعه توسط این منبع
100
بخش عمومی یا خصوصی
عمومی
مبدا اعتبار از داخل یا خارج کشور
داخلی
طبقه بندی منابع اعتبار خارحی
خالی
کشور مبدا
طبقه بندی موسسه تامین کننده اعتبار
دانشگاهی
فرد مسوول پاسخگویی عمومی کارآزمایی
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
Ph.D.
سایر حوزههای کاری/تخصصها
پزشکی اجتماعی
آدرس خیابان
شهر
استان
کد پستی
22511
تلفن
+20 45 3311679
ایمیل
samihareda93@gmail.com
فرد مسوول پاسخگویی علمی مطالعه
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
Ph.D.
سایر حوزههای کاری/تخصصها
پزشکی اجتماعی
آدرس خیابان
شهر
استان
کد پستی
22511
تلفن
+20 45 3311679
ایمیل
samihareda93@gmail.com
فرد مسوول بهروز رسانی اطلاعات
اطلاعات تماس
نام سازمان / نهاد
نام کامل فرد مسوول
موقعیت شغلی
آخرین مدرک تحصیلی
Ph.D.
سایر حوزههای کاری/تخصصها
پزشکی اجتماعی
آدرس خیابان
شهر
استان
کد پستی
22511
تلفن
+20 45 3311679
ایمیل
samihareda93@gmail.com
برنامه انتشار
فایل داده شرکت کنندگان (IPD)
بله - برنامهای برای انتشار آن وجود دارد
پروتکل مطالعه
بله - برنامهای برای انتشار آن وجود دارد
نقشه آنالیز آماری
بله - برنامهای برای انتشار آن وجود دارد
فرم رضایتنامه آگاهانه
بله - برنامهای برای انتشار آن وجود دارد
گزارش مطالعه بالینی
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
کدهای استفاده شده در آنالیز
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
نظام دستهبندی داده (دیکشنری داده)
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
عنوان و جزییات بیشتر در مورد داده/مستند
بازه زمانی امکان دسترسی به داده/مستند
کسانی که اجازه دارند به داده/مستند دسترسی پیدا کنند
به چه منظور و تحت چه شرایطی داده/مستند قابل استفاده است
برای دریافت داده/مستند به چه کسی یا کجا مراجعه شود
یک درخواست برای داده/مستند چه فرایندی را طی میکند