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The effect of psychoeducational counseling on post-traumatic stress disorder and fear of childbirth in pregnant women with experience of childbirth trauma: a randomized controlled trial

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History
# Registration date Revision Id
2 2026-05-08, 1405/02/18 376982
1 2023-02-01, 1401/11/12 254671
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  • General information

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    62
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    2023-03-06, 1401/12/15
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    2023-08-12, 1402/05/21
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    2024-02-10, 1402/11/21
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    The educational content needed to be completed: teaching the birth process, sharing experiences, and relaxation techniques were added. These were included in the proposal but were not recorded in detail in this system.
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    محتوای آموزشی نیاز به کامل شدن داشت: آموزش فرایند زایمان، اشتراک گذاری تجربیات و تکنیکهای ریلکشین اضافه شد. این موارد در پروپوزال لحاظ شده بود ولی با جزئیات در این سامانه ثبت نشده بود.

  • Intervention groups

    #1
    In addition to routine care, the people in the intervention group will participate in 8 counseling sessions of 5-person group psychological education from week 24 to 32. Meetings will be held at an interval of one week and the venue of the meetings will be in Hamedan Comprehensive Health Centers. The time of the mother's presence is determined by their prior arrangement and by phone. The duration of the sessions will be 45-60 minutes. In the present study, women are primarily informed about the issues they are afraid of. In addition, women learn about the pregnancy process, hormones, routine screenings, developing positive health behaviors for a healthy pregnancy, and favorable and unfavorable situations during pregnancy. Knowledge gaps are addressed by correcting misinformation about the onset and stages of labor and midwifery interventions at birth. In addition, women are informed about the type of delivery and the effect of the type of delivery on themselves, the fetus and the postpartum period. Women are encouraged to participate in the decision-making process regarding the type of delivery.
    In addition to routine care, the people in the intervention group will participate in 8 counseling sessions of 5-person group psychological education from week 24 to 32. Meetings will be held at an interval of one week and the venue of the meetings will be in Hamedan Comprehensive Health Centers. The time of the mother's presence is determined by their prior arrangement and by phone. The duration of the sessions will be 45-60 minutes. In the present study, women are primarily informed about the issues they are afraid of. In addition, women are educated about the pregnancy process, hormones, the birth process, pharmacological and non-pharmacological methods of pain relief. Knowledge gaps are addressed by correcting misinformation about childbirth and obstetric interventions at birth, and experiences are shared. In addition, women are informed about the type of delivery and the impact of the type of delivery on themselves, the fetus, and the postpartum period. Women practice relaxation techniques such as breathing techniques, distraction, and muscle relaxation in all sessions.
    افراد گروه مداخله علاوه بر مراقبتهای روتین، در 8 جلسه مشاوره آموزش روانی گروهی 5 نفره از هفته 24 تا 32 شرکت خواهند کرد. جلسات به فاصله یک هفته برگزار می شود و محل برگزاری جلسات در مراکز جامع سلامت همدان خواهد بود. زمان حضور مادر با هماهنگی قبلی آنها و بصورت تلفنی تعیین می شود. مدت زمان جلسات 60-45 دقیقه خواهد بود. در مطالعه حاضر، زنان در درجه اول از مسائلی که از آنها می ترسند مطلع می شوند. علاوه بر این، زنان در مورد روند بارداری، هورمون ها، غربالگری های معمول، ایجاد رفتارهای سلامتی مثبت برای بارداری سالم و موقعیت های مطلوب و نامطلوب در دوران بارداری مطلع می شوند. کمبودهای دانش با اصلاح اطلاعات اشتباه در مورد علائم شروع و مراحل زایمان و مداخلات مامایی در بدو تولد برطرف می شود. علاوه بر این، زنان در مورد نوع زایمان و تأثیر نوع زایمان بر خود، جنین و دوره پس از زایمان مطلع می شوند. زنان تشویق می شوند تا در فرآیند تصمیم گیری در مورد نوع زایمان شرکت کنند .
    افراد گروه مداخله علاوه بر مراقبتهای روتین، در 8 جلسه مشاوره آموزش روانی گروهی 5 نفره از هفته 24 تا 32 شرکت خواهند کرد. جلسات به فاصله یک هفته برگزار می شود و محل برگزاری جلسات در مراکز جامع سلامت همدان خواهد بود. زمان حضور مادر با هماهنگی قبلی آنها و بصورت تلفنی تعیین می شود. مدت زمان جلسات 60-45 دقیقه خواهد بود. در مطالعه حاضر، زنان در درجه اول از مسائلی که از آنها می ترسند مطلع می شوند. علاوه بر این، زنان در مورد روند بارداری، هورمون ها، فرایند زایمان، روشهای دارویی و غیردارویی کاهش درد آموزش می بینند. کمبودهای دانش با اصلاح اطلاعات اشتباه در مورد زایمان و مداخلات مامایی در بدو تولد برطرف می شود و تجربیات به اشتراک گذاشته می شوند. علاوه بر این، زنان در مورد نوع زایمان و تأثیر نوع زایمان بر خود، جنین و دوره پس از زایمان مطلع می شوند. زنان در تمام جلسات تکنیکهای ریلکسیشن مانند تکنیکهای تنفسی، انحراف فکر و آرامسازی عضلانی را تمرین می کنند.

  • Recruitment centers

    #1
    Name of recruitment center - English: comprehensive health centers of Hamedan city
    Name of recruitment center - Persian: مراکز جامع سلامت شهر همدان
    Full name of responsible person - English: Farideh Kazemi
    Full name of responsible person - Persian: فریده کاظمی
    Street address - English: Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
    Street address - Persian: همدان، چهارراه پژوهش، بلوار شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 08138380150
    Phone: +98 918 312 7351
    Fax:
    Email: faridehkazemi21@yahoo.com
    Web page address:
    Name of recruitment center - English: Comprehensive Health Centers of Hamedan city
    Name of recruitment center - Persian: مراکز جامع سلامت شهر همدان
    Full name of responsible person - English: Farideh Kazemi
    Full name of responsible person - Persian: فریده کاظمی
    Street address - English: Hamedan University of Medical Sciences (UMSHA), Pazhouhesh Crossroad., Hamadan, Iran.
    Street address - Persian: همدان، چهارراه پژوهش، بلوار شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 08138380150
    Phone: +98 918 312 7351
    Fax:
    Email: faridehkazemi21@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: Deputy of research and technology of Hamadan University of Medical Sciences
    Full name of responsible person - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی همدان
    Street address - English: Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
    Street address - Persian: همدان، چهارراه پژوهش، بلوار شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 08138380150
    Phone: +98 918 312 7351
    Fax:
    Email: faridehkazemi21@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Reza Shokoohi, Deputy of research and technology of Hamadan University of Medical Sciences
    Full name of responsible person - Persian: دکتر رضا شکوهی، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی همدان
    Street address - English: Hamedan University of Medical Sciences (UMSHA), Pazhouhesh Crossroad., Hamadan, Iran.
    Street address - Persian: همدان، چهارراه پژوهش، بلوار شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 08138380150
    Phone: +98 918 312 7351
    Fax:
    Email: shokoohi@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the effect of psychoeducational counseling on post-traumatic stress disorder and fear of childbirth in pregnant women with a history of traumatic childbirth
Design
The randomized controlled clinical trial, with a 1:1 parallel design will be conducted on 70 pregnant women with a history of previous traumatic childbirth. Blocked randomization will be done using web-based software
Settings and conduct
Pregnant women if they meet the inclusion criteria are assigned to the intervention or control group based on the predetermined allocation sequence. Holding 8 counseling sessions of psychological education in groups of 5 in Psychoeducational counseling sessions are held one week apart in comprehensive health centers in Hamedan. The duration of the sessions will be 45-60 minutes. Mothers in the control group received only routine care. To comply with ethical considerations, after the end of the study, a group meeting will be held for the mothers of the control group. At the 36th week of pregnancy, mothers of both groups are invited to complete the PSS-SR and CAQ questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: score 12 and above based on PSS-SR questionnaire; having a history of pregnancy and childbirth; previous vaginal delivery. Exclusion criteria: not attending two counseling sessions; hospitalization or early termination of pregnancy.
Intervention groups
Intervention group: in addition to routine care, holding 8 counseling sessions of psychological education in groups of 5 in weeks 24 to 32; Control group: routine care.
Main outcome variables
Post-traumatic stress disorder and fear of childbirth

General information

Reason for update
The educational content needed to be completed: teaching the birth process, sharing experiences, and relaxation techniques were added. These were included in the proposal but were not recorded in detail in this system.
Acronym
IRCT registration information
IRCT registration number: IRCT20201102049233N2
Registration date: 2023-02-01, 1401/11/12
Registration timing: prospective

Last update: 2026-05-08, 1405/02/18
Update count: 1
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Farideh Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
f.kazemi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
2023-03-06, 1401/12/15
Actual recruitment end date
2023-08-12, 1402/05/21
Trial completion date
2024-02-10, 1402/11/21
Scientific title
The effect of psychoeducational counseling on post-traumatic stress disorder and fear of childbirth in pregnant women with experience of childbirth trauma: a randomized controlled trial
Public title
Post-traumatic stress disorder and fear of childbirth in pregnant women with experience of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Score 12 and above based on PSS-SR questionnaire Having a history of pregnancy and childbirth Previous vaginal delivery Gestational age 28-30 weeks at the time of entering the study Singleton pregnancy in the current pregnancy Being literate in reading and writing Ability to speak Persian Not suffering from mental illnesses diagnosed based on the records available in comprehensive health centers Not suffering from medical diseases such as diabetes, hypertension, thyroid, liver, heart diseases, etc. according to the file Not suffering from pregnancy complications such as gestational diabetes, pre-eclampsia, placenta previa and IUGR, etc. according to the file The absence of an unfortunate incident in the last month
Exclusion criteria:
Not attending two counseling sessions Hospitalization or early termination of pregnancy due to pregnancy-related complications during the intervention period The occurrence of an unfortunate accident for the participant Suffering from mental disorders or taking psychiatric drugs based on the person's own statements
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 62
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign mothers to the intervention and control groups, a 4 and 6 random blocking method is used. To do this, the allocation sequence is first determined using AABB blocks before the start of the study. Then, the type of intervention is written in opaque closed envelopes based on the specified sequence and is numbered in sequence. Participants will complete a demographic and midwifery information questionnaire and receive an envelope before entering the study. People are then placed in one of the control or intervention groups based on the contents of the envelope.
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 Hamadan University of Medical Sciences
Street address
In front of Mardom's Park, Research Square
City
Hamedan
Province
Hamadan
Postal code
6517838687
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.732

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Post-traumatic stress disorder and fear of childbirth scores
Timepoint
Before the intervention and 4 weeks after the end of the counseling sessions
Method of measurement
Posttraumatic Stress Disorder Self-Report Scale (PSS-SR) and Childbirth Attitude Questionnaire(CAQ)

Secondary outcomes

empty

Intervention groups

1

Description
In addition to routine care, the people in the intervention group will participate in 8 counseling sessions of 5-person group psychological education from week 24 to 32. Meetings will be held at an interval of one week and the venue of the meetings will be in Hamedan Comprehensive Health Centers. The time of the mother's presence is determined by their prior arrangement and by phone. The duration of the sessions will be 45-60 minutes. In the present study, women are primarily informed about the issues they are afraid of. In addition, women are educated about the pregnancy process, hormones, the birth process, pharmacological and non-pharmacological methods of pain relief. Knowledge gaps are addressed by correcting misinformation about childbirth and obstetric interventions at birth, and experiences are shared. In addition, women are informed about the type of delivery and the impact of the type of delivery on themselves, the fetus, and the postpartum period. Women practice relaxation techniques such as breathing techniques, distraction, and muscle relaxation in all sessions.
Category
Other

2

Description
Control group: Routine prenatal care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers of Hamedan city
Full name of responsible person
Farideh Kazemi
Street address
Hamedan University of Medical Sciences (UMSHA), Pazhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 918 312 7351
Email
faridehkazemi21@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi, Deputy of research and technology of Hamadan University of Medical Sciences
Street address
Hamedan University of Medical Sciences (UMSHA), Pazhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 918 312 7351
Email
shokoohi@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
08138380150
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farideh Kazemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hamedan University of Medical Sciences (UMSHA), PaZhouhesh Crossroad., Hamadan, Iran.
City
Hamedan
Province
Hamadan
Postal code
6519964885
Phone
+98 81 3838 0150
Email
faridehkazemi21@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be accessible if necessary
When the data will become available and for how long
After the results are published
To whom data/document is available
The data will be provided to academic and scientific institutions if necessary
Under which criteria data/document could be used
If a meta-analysis is required, the data will be made available to the corresponding author
From where data/document is obtainable
Correspondence with the responsible person by email
What processes are involved for a request to access data/document
If you agree to the request, the data will be sent by email.
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