The Effect of Acceptance and Commitment Therapy- based Sexual Health on Body Image Acceptance and Sexual Well-Being in Primiparous Women after Childbirth
The Effect of Acceptance and Commitment Therapy- based Sexual Health on Body Image Acceptance and Sexual Well-Being in Primiparous Women after Childbirth
Design
A randomized controlled clinical trial with a parallel-group design and no blinding was conducted on 120 patients. Randomization was performed using R software.
Settings and conduct
Participants were recruited via random sampling from the Comprehensive Health Service Centers. This study is an unblinded clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Age 18 to 40 years
- First childbirth experience
- At least 6 weeks and at most 6 months since delivery
- Active marital cohabitation with the spouse
- Informed consent to participate in the study
- No severe mental disorder based on the health record
- Planned pregnancy
- No history of infertility
- No symptoms of depression, based on the Edinburgh Depression Questionnaire score
- No use of psychiatric or hormonal medications affecting sexual function
Exclusion criteria
- Subsequent pregnancy during the study period
- Absence from more than one counseling session
- Participation in similar interventions during the study period
- Withdrawal from the study at any stage
Intervention groups
Participants in the intervention group will receive Sexual Acceptance and Commitment Therapy (Sexual ACT) over four weekly 90-minute group counseling sessions. The sessions will encompass mindfulness training, acceptance of internal experiences, identification of personal values, commitment to value-based action, and restructuring of attitudes toward body image and sexual relationships.
Main outcome variables
Body Image Acceptance and Sexual Well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260607069679N1
Registration date:2026-06-17, 1405/03/27
Registration timing:prospective
Last update:2026-06-17, 1405/03/27
Update count:0
Registration date
2026-06-17, 1405/03/27
Registrant information
Name
Mohadese Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6730
Email address
mohadeseamiri028@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-11, 1405/04/20
Expected recruitment end date
2026-11-11, 1405/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acceptance and Commitment Therapy- based Sexual Health on Body Image Acceptance and Sexual Well-Being in Primiparous Women after Childbirth
Public title
The Effect of Acceptance and Commitment Therapy- based Sexual Health on Body Image Acceptance and Sexual Well-Being in Primiparous Women after Childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 40 years
Primiparous women (first childbirth experience)
At least 6 weeks and at most 6 months postpartum
Being in an active marital/sexual relationship with the spouse
Willingness to participate in the study and providing informed consent
No severe mental disorder based on the health record
Planned/wanted pregnancy
No history of infertility
No signs of depression (based on the Edinburgh questionnaire score)
No use of psychiatric medications or hormonal medications affecting sexual function
Exclusion criteria:
Becoming pregnant again during the study
Absence from more than one counseling session
Participation in similar interventions during the study period
Withdrawal from further cooperation at any stage of the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method, parallel unit of randomization, the blockrand statistical package in R software will be used to generate the allocation sequence, no blinding.
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 Mashhad University of Medical Sciences
Street address
Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2026-04-27, 1405/02/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1405.004
Health conditions studied
1
Description of health condition studied
Body Image Acceptance and Sexual Well-Being
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body Image Acceptance
Timepoint
Before the intervention, immediately after the intervention, and one month after the intervention
Method of measurement
Body Image–Acceptance and Action Questionnaire: BI-AAQ,Female Sexual Well-Being Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, participants will receive Sexual Acceptance and Commitment Therapy (Sexual ACT) through four weekly 90-minute group counseling sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Service Centers
Full name of responsible person
Rahele Babazade
Street address
Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 992 340 8252
Email
mohadeseamiri028@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Rahele Babazade
Street address
Kharazmi Educational Complex, Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 992 340 8252
Email
mohadeseamiri028@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university
Proportion provided by this source
20
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohadese Amiri
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kharazmi Educational Complex, Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051433339273
Email
mohadeseamiri028@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadese Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kharazmi Educational Complex, Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Fax
Email
mohadeseamiri028@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadese Amiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kharazmi Educational Complex, Ferdowsi University of Mashhad Campus, East Entrance, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3884 6730
Fax
Email
mohadeseamiri028@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information related to the primary outcome and related measures may be shared.
When the data will become available and for how long
Access to the data will begin 6 months after the publication of the results
To whom data/document is available
Graduate students and researchers
Under which criteria data/document could be used
The information will be made available to individuals conducting research in this field or related topics, if necessary, while preserving the authors’ rights and publication rights.
From where data/document is obtainable
Mohadese Amiri
mohadeseamiri028@gmail.com
09923418252
What processes are involved for a request to access data/document
Upon receiving the request, it will be reviewed and discussed with the research team, and a response will be provided to the applicant.