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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
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
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.
-
Comments
-