Investigating the effect of psychodrama group therapy on fear of childbirth, childbirth experience and postpartum depression symptoms in first born women: an experimental study
Comparison of the mean score of fear of childbirth between two groups at 35-37 weeks of pregnancy by adjusting the effect of baseline score
Comparison of the average score of childbirth experience between two groups, one month after delivery
Comparison of the average score of postpartum depression between two groups, one month after delivery with adjustment of the effect of baseline score
Design
A clinical trial with a control group, with parallel groups, randomized, on 70 pregnant women, randomization through randomized blocks with 4 and 6 blocks into two groups (35 women in each group) with a ratio of 1:1 allocation will be given
Settings and conduct
The present study will be conducted in the Taleghani educational and therapeutic center of Tabriz city. Sampling will be done as available and based on the study entry and exit criteria. People will be randomly divided into intervention and control groups. People in the intervention group will receive psychodrama-based intervention in 8 sessions by a psychology expert in groups of 4-6 people.
Participants/Inclusion and exclusion criteria
Conditions for inclusion in the study include first born women with a gestational age of 24-28 weeks and a score above 65 in the fear of childbirth questionnaire, and exclusion conditions include mental disorders, fetal abnormalities, medical and obstetric problems
Intervention groups
Participants will be divided into two intervention and control groups after declaring their consent to participate in the study. The intervention group will receive psychodrama-based intervention by a psychology expert. The control group will not receive psychological intervention, including psychotherapy, group therapy, and individual counseling. But both groups can participate in pregnancy classes.
Main outcome variables
fear of childbirth; childbirth experience; Symptoms of postpartum depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220926056046N4
Registration date:2024-03-06, 1402/12/16
Registration timing:registered_while_recruiting
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Solmaz Ghanbari Homaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3524 5181
Email address
homayisolmaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of psychodrama group therapy on fear of childbirth, childbirth experience and postpartum depression symptoms in first born women: an experimental study
Public title
Investigating the effect of psychodrama group therapy on fear of childbirth, childbirth experience and postpartum depression symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years
Gestational age 24 to 28 weeks
first born
having at least middle school literacy
The fear of childbirth score is above 65 according to the fear of childbirth questionnaire
Exclusion criteria:
History of mental disorders before and during pregnancy according to the patient's statement
Fetal abnormality
Risky medical and obstetric problems such as hypertension, diabetes, placenta previa, cardiopulmonary diseases and other chronic diseases, continuous bleeding, incompetent cervix, high-risk multiple pregnancy
A history of frequent abortions and pregnancies with laboratory methods such as
Having a medical indication for cesarean section
A depression score above 13 based on the Edinburgh postpartum depression questionnaire
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done according to the available method and according to the inclusion and non-entry criteria. The sample people will be assigned to two groups (35 women in each group) with a ratio of 1:1 through random blocks with blocks of 4 and 6. The type of allocation will be written on paper and placed in consecutively numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in order by a person not involved in sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
A person who is not involved in sampling will be asked to review the results at the end of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction,number2,Tabriz university of medical science, Azadi Ave
City
Tabiz
Province
East Azarbaijan
Postal code
5155668474
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.TBZMED.REC.1402.849
Health conditions studied
1
Description of health condition studied
Fear of childbirth, postpartum depression
ICD-10 code
O9A.51
ICD-10 code description
postpartum depression
Primary outcomes
1
Description
The average score of fear of childbirth
Timepoint
24-28 weeks of pregnancy, 35-37 weeks of pregnancy
Method of measurement
WDE-Q(A) fear of childbirth questionnaire
Secondary outcomes
1
Description
The average score of childbirth experience
Timepoint
Four weeks after birth
Method of measurement
Childbirth Experience Questionnaire
2
Description
Postpartum depression symptoms score
Timepoint
Four weeks after birth
Method of measurement
Edinburg Depression Scale
Intervention groups
1
Description
Intervention group: Intervention group: People in the intervention group will be in groups of 4-6 people, 8 sessions (one session per week) of psychodrama-based intervention will be held. The implementation of psychodrama in this project will be performed by a clinical psychology specialist (female psychologists) and trained people under the supervision of an expert psychiatrist (female psychiatrist) in the field of psychological disorders during pregnancy and childbirth. Performing psychodrama is an interdisciplinary intervention, therefore, in addition to having a professional qualification in psychology, the therapist must have education and work in the field of drama and drama. Psychodrama in the current project will be performed by a clinical psychology specialist with a specialized employment license from the psychology system, who has completed a specialized psychodrama course under the supervision of a psychiatrist and an expert psychotherapist in the field of psychodrama. The contents of the sessions include: the first session (group therapy with the psychodrama method and the effect of group activity in solving problems by the therapist) - the second session (various emotions such as happiness, sadness, fear, anger, loneliness, worry, etc. alternately through facial expressions) and the performance will be practiced in the body) - the third session (based on the clients' recorded memories, focusing on a specific topic and individually and in a group by creating a calm and carefree atmosphere and using stage equipment, music and other clients in the form Defined roles are helped to the clients so that their mental fluid flow is implemented (fourth session) (Continuation of the clients' experiences from their real life by themselves as the protagonist or the hero, they are implemented and manifested objectively) - The fifth session (unpleasant experiences and inefficient feelings and thoughts of the clients are performed by other members of the group, and this time the clients observe their experiences from the perspective of the audience) - The sixth session (using group creativity, bitter and unpleasant experiences of the clients be implemented again and this time with the conscious performance of the client, leading to the formation of a pleasant and controllable experience) - the seventh session (accurate simulation of the life situations of each client continues) - the eighth session (reviewing the previous sessions and discovering changes Constructive in member relationships, increasing awareness, empathy and confrontation in social interactions, discovering new patterns and reducing conflicts, explaining roles, relationships between people, values and revealing new desirable feelings and thoughts and behaviors that are fruitful with group solidarity. )
Category
Behavior
2
Description
Control group: The control group will not receive psychological intervention, including psychotherapy, group therapy, and individual counseling. But both groups can participate in pregnancy classes
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Medical Education Center, Tabriz
Full name of responsible person
Solmaz Ghanbari Homayi
Street address
Rah Ahan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3442 4421
Email
mmi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research department, third floor, central construction,number2,Tabriz university of medical science, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3334 4280
Fax
+98 41 3334 4280
Email
research-vice@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
Solmaz Ghanbari Homayi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098415223478
Email
homayisolmaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homayi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098415223478
Email
homayisolmaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Ghanbari Homayi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
513897977
Phone
+98 41 5229 3478
Email
homayisolmaz@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
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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