Effectiveness of Digital Childbirth Storytelling on Childbirth Self-Efficacy and Psychosocial Adaptation to Pregnancy among Nulliparous Pregnant Women : A Randomized Controlled Trial
To determine the effect of digital childbirth storytelling on childbirth self-efficacy and psychosocial adaptation to pregnancy in nulliparous pregnant women.
Design
Cluster randomized controlled trial with parallel groups and a control group; eight comprehensive health centers as clusters; four centers allocated to intervention and four to control using a random number table; sample size 80 (40 per group); single-blind only for the statistical analyst; non-pharmacological phase.
Settings and conduct
.Cluster randomized trial with pretest-posttest and a control group at comprehensive health centers in Shahrekord; recruitment of nulliparous women at 24–28 weeks of gestation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: providing informed consent; nulliparity; singleton pregnancy; gestational age of 24–28 weeks; age 18–49 years; ability to use digital devices and access the internet; attendance at childbirth preparation classes; no history of infertility or psychiatric disorders and no use of psychiatric medications.
Exclusion criteria: lack of informed consent; multiparity or multiple gestation; gestational age outside 24–28 weeks; age outside 18–49 years; inability to use digital devices or lack of internet access; non-attendance at childbirth preparation classes; history of infertility or psychiatric disorders or use of psychiatric medications.
Intervention groups
Intervention: online digital childbirth storytelling package (six educational-narrative animations, two narrated PowerPoints, and educational infographics) over six weeks; Control: usual prenatal care and childbirth preparation classes without the package.
Main outcome variables
Childbirth self-efficacy; psychosocial adaptation to pregnancy.
General information
Reason for update
Acronym
DCST-PSA Trial
IRCT registration information
IRCT registration number:IRCT20260906070943N1
Registration date:2026-10-22, 1405/07/30
Registration timing:prospective
Last update:2026-10-22, 1405/07/30
Update count:0
Registration date
2026-10-22, 1405/07/30
Registrant information
Name
Ehteram Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3332 3884
Email address
ehteram.hashemi.sh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-11-06, 1405/08/15
Expected recruitment end date
2027-03-06, 1405/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Digital Childbirth Storytelling on Childbirth Self-Efficacy and Psychosocial Adaptation to Pregnancy among Nulliparous Pregnant Women : A Randomized Controlled Trial
Public title
Effectiveness of Digital Childbirth Storytelling on Childbirth Self-Efficacy and Psychosocial Adaptation to Pregnancy among Nulliparous Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and provide informed consent
Gestational age of 24 to 28 weeks
Being nulliparous
No history of diagnosed psychiatric disorders or use of psychiatric medications based on the health record or participant self-report
Ability to use digital devices such as a mobile phone or computer
Access to the internet
Participation in childbirth preparation classes
Singleton pregnancy
No history of infertility
Age 18 to 49 years
Exclusion criteria:
Presence of a medical or obstetric complication requiring specialized care that makes participation in the study inappropriate
Presence of a documented psychiatric or psychological disorder that may substantially affect the assessment of childbirth self-efficacy or psychosocial adaptation.
History of childbirth or a previous pregnancy reaching the stage of fetal viability.
A confirmed indication for planned cesarean delivery at the time of enrollment.
Concurrent participation in a structured childbirth education program or a similar psychological intervention
Lack of access to the digital device required to receive the digital childbirth storytelling intervention.
Inability to use the digital platform required to receive the intervention.
Inability to understand the study information or complete the study questionnaires due to cognitive or language limitations.
Unwillingness to provide informed consent before randomization.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eight centers providing childbirth preparation classes will be considered as study clusters. Four centers will be allocated to the intervention group and four centers to the control group using a random number table. Subsequently, the list of nulliparous pregnant women at 24–28 weeks of gestation will be obtained from the SIB health information system of each center. After screening for the eligibility criteria, eligible participants will be selected from each center using simple random sampling according to the predetermined allocation quota for that center. A total of 80 pregnant women will be included in the study, with 40 participants in the intervention group and 40 in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this clinical trial, single-blinding will be used. Blinding will be applied to the statistical analyst; the analyst will not be informed about the content of the intervention received by the groups, and the raw data file will be provided to the analyst under the labels Intervention A and Intervention B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahrekord and Borujen Schools of Nursing and Midwifery and School of
Street address
Research and Technology Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2026-08-17, 1405/05/26
Ethics committee reference number
IR.SKUMS.NUMHE.REC.1405.057
Health conditions studied
1
Description of health condition studied
Nulliparous pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Childbirth Self-Efficacy
Timepoint
Before the intervention, immediately after the intervention, and 4 weeks after the intervention
Method of measurement
Total score of the Iranian short form of the Childbirth Self-Efficacy Inventory (CBSEI-C32)
Secondary outcomes
1
Description
Psychosocial Adaptation to Pregnancy
Timepoint
Before the intervention, immediately after the intervention, and 4 weeks after the intervention
Method of measurement
Total score of the Prenatal Self-Evaluation Questionnaire (PSEQ)
Intervention groups
1
Description
Digital childbirth storytelling package including six educational-narrative animations, two narrated PowerPoint presentations, and educational infographics, delivered online over six weeks
Category
Behavior
2
Description
Usual prenatal care and childbirth preparation classes, without receiving the digital childbirth storytelling package
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord County Health Center
Full name of responsible person
Ehteram Hashemi
Street address
Next to Mosalla, Shahid Bahonar Street.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817614369
Phone
+98 38 3222 4489
Email
skums_it@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Ali Hasanpour
Street address
Third Floor, Research Deputy, Central Headquarters, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord, Iran.
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 6518
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Faranak Safdari
Position
Assistant Professor, Head of the Midwifery Department
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahrekord University of Medical Sciences, Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3334 1216
Email
faranaksafdari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ehteram Hashemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
009833341216
Email
ehteram.hashemi.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ehteram Hashemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrekord University of Medical Sciences, Rahmatiyeh,
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
009833341216
Email
ehteram.hashemi.sh@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