Investigating the effectiveness of cognitive restructuring based on therapeutic metaphor on fear of childbirth in primiparous women
Design
This is a randomized clinical trial with a parallel design and control group. This randomized, non-blinded study will be conducted on eligible pregnant women. The randomized block design will be used for randomization, and participants will be assigned to two intervention and control groups.
Settings and conduct
This non-blinded study will be conducted at the Hafezieh Health Center in Kermanshah. At the beginning of the study, a fear of childbirth questionnaire will be provided to primiparous women.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Gestational age between 28 and 32 weeks; Obtaining a score of 66-84 on the fear of childbirth questionnaire; Being a firstborn; Having a singleton pregnancy
Exclusion criteria: History of underlying disease or complications during pregnancy (preeclampsia, gestational diabetes); History of taking neuroleptic drugs; History of smoking addiction; History of alcohol and drug use; History of recurrent miscarriages (3 or more consecutive miscarriages); History of infertility; Indication for cesarean delivery
Intervention groups
The intervention group, in addition to routine prenatal care, will receive 6 group sessions (one session per week), each session lasting 60-90 minutes, of cognitive restructuring intervention based on metaphor therapy. The control group will receive routine prenatal care according to the national protocol.
Main outcome variables
Fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N273
Registration date:2026-01-09, 1404/10/19
Registration timing:prospective
Last update:2026-01-09, 1404/10/19
Update count:0
Registration date
2026-01-09, 1404/10/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2026-02-19, 1404/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of cognitive restructuring based on therapeutic metaphor on fear of childbirth in primiparous women
Public title
Investigating the effectiveness of cognitive restructuring on fear of childbirth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Gestational age between 28 and 32 weeks
Obtaining a score of 66-84 on the fear of childbirth questionnaire
Being a first-born
Having a singleton pregnancy
Exclusion criteria:
History of underlying disease or complications during pregnancy (preeclampsia, gestational diabetes)
History of taking neuroleptic drugs
History of smoking addiction
History of alcohol and drug use
History of recurrent miscarriages (3 or more consecutive miscarriages)
History of infertility
Indication for cesarean delivery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random block. These blocks are created by a computer using the https://www.sealedenvelope.com site, and each individual will be given a unique code to ensure careful concealment of the randomization process. The generation of blocks and assignment of codes will be done by a third party (the person in charge of the selected center) who has no role in the process of assigning individuals to groups. The allocation ratio between the control and intervention groups is considered to be 1:1, meaning that in each block of four, two individuals will be assigned to the control group and two individuals to the intervention 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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kerrmanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-12-06, 1404/09/15
Ethics committee reference number
IR.KUMS.REC.1404.520
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Fear of childbirth
Timepoint
One week and four weeks after the intervention and during the first week after delivery
Method of measurement
Using the Fear of Childbirth Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, in addition to routine prenatal care, will receive 6 group sessions (one session per week), each session lasting 60-90 minutes, of cognitive restructuring intervention based on metaphor therapy. Summary of the intervention includes: awareness of the role of thoughts in creating fear of childbirth, replacing rational thoughts with thoughts that cause fear of childbirth, defining catastrophizing and hasty conclusions of a prophetic nature, and expressing an analogy related to catastrophizing.
Category
Behavior
2
Description
The control group will receive routine prenatal care according to the national protocol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafeziyeh Health Center
Full name of responsible person
Zahra Zaeri
Street address
Next to Hafeziyeh Girls' Middle School, 45 meters from Hafeziyeh 2nd, Hafeziyeh
City
Kermanshah
Province
Kermanshah
Postal code
671581154
Phone
+98 83 3836 7909
Email
ZahraZaeri8486@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Zahra Zaeri
Position
Master's degree student in consulting in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
ZahraZaeri8486@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh Kamravamanesh
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mastaneh Kamravamanesh
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
kamravamanesh@yahoo.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