evaluate the effectiveness of self-compassion-based counseling on body image in postmenopausal women with body image concern compared to a control group.
Design
An open-label, parallel-group randomized clinical trial with a 1:1 allocation ratio. 44 postmenopausal women are assigned to intervention (n=22) or control (n=22) groups. Randomization uses permuted blocks in SPSS, and allocation concealment uses sequentially numbered opaque sealed envelopes.
Settings and conduct
A parallel-group randomized clinical trial conducted at Lali Comprehensive Health Centers. 44 eligible postmenopausal women are randomly assigned (1:1) to intervention (self-compassion counseling) or control (routine care) groups. Randomization is performed via permuted blocks in SPSS, with allocation concealment using opaque sealed envelopes. This is an open-label study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women aged 45–60 years, literate, body mass index (BMI) between 18.5 and 30, Body Image Concern Inventory (BICI) score higher than 57.Exclusion criteria: history of severe psychiatric disorders, physical defects or diseases affecting body image, prior training in self-compassion, receiving parallel interventions related to body image.
Intervention groups
Intervention group: receiving self-compassion-based counseling in eight 90-minute group sessions (two sessions per week). Control group: receiving routine care and health education of health centers. The allocation ratio is 1:1.
Main outcome variables
1.Body Image (assessed by the Body Image Concern Inventory - BICI score)
2.Body Image (assessed by the Multidimensional Body-Self Relations Questionnaire - MBRSQ score)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260922071154N1
Registration date:2026-10-07, 1405/07/15
Registration timing:prospective
Last update:2026-10-07, 1405/07/15
Update count:0
Registration date
2026-10-07, 1405/07/15
Registrant information
Name
Effat Jahanbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4329 4664
Email address
ftjhanbyn23@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-16, 1405/07/24
Expected recruitment end date
2026-11-20, 1405/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Self-Compassion-Based Counseling on Body Image in Menopausal Women.
Public title
Investigating the Effectiveness of Self-Compassion-Based Counseling on the Body Image of Menopausal Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women aged 45 to 60 years
Ability to read and write
Having a body mass index (BMI) between 18.5 and 30 kg/m²
Obtaining a score greater than 57 on the Body Image Concern Inventory (BICI)
Willingness and motivation to participate in the study and providing informed consent
Exclusion criteria:
Having severe physical diseases or conditions that may affect body image, such as amputation, mastectomy, or similar conditions
Having a history of severe psychiatric disorders
Having significant physical defects or deformities that may affect body image
Having prior knowledge or training in self-compassion or a history of participation in self-compassion-based counseling sessions or courses
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Unit of Randomization: Individual-level randomization.Randomization Technique: Participants will be assigned to either the intervention or the control group using a permuted block randomization technique to ensure an equal distribution of participants between the two groups throughout the recruitment period. To maintain balance and prevent predictability, block sizes of 4, 6, and 8 will be utilized.
Sequence Generation: The randomization sequence will be generated using a computer-based random number generator (e.g., via statistical software like SPSS or R) to ensure a truly stochastic process.
Allocation Concealment: To ensure rigorous allocation concealment and minimize selection bias, the assignment will be implemented through sequentially allocated, opaque, and sealed envelopes. The allocation process will be managed by a researcher who is not involved in the recruitment or clinical assessment of the participants.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2026-09-13, 1405/06/22
Ethics committee reference number
IR.AJUMS.REC.1405.288
Health conditions studied
1
Description of health condition studied
Menopausal state and body image dissatisfaction
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
The primary outcome is body image among menopausal women, assessed in both the intervention and control groups using the Multidimensional Body-Self Relations Questionnaire (MBSRQ) before the intervention and after completion of the counseling program. The aim is to compare body image outcomes between the two groups after the intervention.
Timepoint
Before the intervention; immediately after the intervention; one month after the intervention
Method of measurement
Body image will be measured using the Multidimensional Body-Self Relations Questionnaire (MBSRQ). The questionnaire will be completed by participants at three time points: before the intervention, immediately after the intervention, and one month after the intervention.
Secondary outcomes
1
Description
Appearance evaluation:Assessing the individual's feelings of physical attractiveness and general satisfaction with appearance; higher scores reflect greater satisfaction and more positive appearance evaluation.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Appearance Evaluation subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 7 items scored on a 5-point Likert scale (1=definitely disagree to 5=definitely agree).
2
Description
Appearance orientation:Assessing cognitive and behavioral investment in one's physical appearance and grooming behaviors.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Appearance Orientation subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 12 items scored on a 5-point Likert scale (1 to 5).
3
Description
Fitness evaluation:Assessing the perception and feelings of being physically fit, athletic, and competent in physical activities.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Fitness Evaluation subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 3 items scored on a 5-point Likert scale (1 to 5).
4
Description
Fitness orientation:Assessing the extent of behavioral investment in maintaining and improving personal fitness and participating in physical fitness activities.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Fitness Orientation subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 13 items scored on a 5-point Likert scale (1 to 5).
5
Description
Overweight preoccupation (Fear of weight):Assessing fat anxiety, weight vigilance, fear of weight gain, and tendencies toward restrictive dieting.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
6
Description
Body areas satisfaction:Assessing individual satisfaction or dissatisfaction with discrete aspects and areas of the body (e.g., face, mid torso, lower torso, muscle tone, weight, and height).
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Body Areas Satisfaction Scale (BASS) subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 5 items scored on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied).
7
Description
Subjective weight classification:Assessing the participant's perception and subjective appraisal of their own weight status ranging from very underweight to very overweight.
Timepoint
Baseline (pre-intervention), immediately post-intervention (week 4), and one month post-intervention (follow-up)
Method of measurement
Subjective Weight subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ), consisting of 2 items scored on a 5-point scale.
Intervention groups
1
Description
Intervention group: Intervention group: Participants in the intervention group will receive group self-compassion-based counseling (based on Paul Gilbert’s Compassion-Focused Therapy framework) in groups of 8 to 10 participants. The program consists of 8 sessions of 90 to 120 minutes each, conducted twice weekly over a period of 4 weeks in a designated counseling room at the healthcare center. The sessions will be facilitated by a trained researcher under the supervision of a clinical psychology consultant.Each session includes reviewing previous homework, introducing new concepts, practical exercises, and assigning home practices.The session outlines are as follows:Session 1: Orientation, establishing ground rules, introduction to self-compassion and body image,identifying negative body thoughts.Session 2: Body mindfulness, non-judgmental acceptance of the present moment, and body scan meditation.Session 3: Confronting the inner critic, reducing bodily self-criticism, and compassionate cognitive reframing.Session 4: Disengaging from social comparison and analyzing socio-cultural/media influences on body ideals.Session 5: Body kindness, enhancing self-care behaviors, and writing a compassionate letter to one’s body.Session 6: Coping with body shame and implementing soothing self-regulation techniques.Session 7: Restructuring limiting beliefs and cultivating an inner compassionate voice.Session 8: Summary, developing an individualized long-term self-care plan,written commitment, and post-intervention assessment.Body image will be evaluated using the Multidimensional Body-Self Relations Questionnaire (MBSRQ) at baseline, immediately post-intervention, and at a 1-month follow-up.
Category
Behavior
2
Description
Control group:Participants in the control group will receive routine standard healthcare services provided by the community health center and will not receive any psychological or counseling intervention during the study period. They will complete the evaluation questionnaires at identical time points: baseline, immediately after the intervention period (at 4 weeks), and at the 1-month follow-up. For ethical considerations, educational materials summarizing the sessions will be provided to the control group in the form of an instructional CD after the completion of the follow-up assessment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban Comprehensive Health Service Centers No. 1 and 2
Full name of responsible person
Effat Jahanbin
Street address
School of Nursing and Midwifery Ahvaz Jundishapur University of Medical Sciences Golestan Boulevard, Esfand Street, Ahvaz, Khuzestan, Iran Postal Code: 61357-15794 Tel: +98 61 3373 8538
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8538
Email
javadifar-n@ajums.ac.ir
Web page address
https://ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Abdollah Rafiei
Street address
Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Web page address
http://ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Effat Jahanbin
Position
MSc Student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 992 312 1611
Email
ftjhanbyn23@gmail.com
Web page address
https://ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadi-Far
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3320 9238
Email
nahidjavadifar_341@yahoo.com
Web page address
https://ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Effat Jahanbin
Position
MSc Student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery Ahvaz Jundishapur University of Medical Sciences Golestan Boulevard, Esfand Street, Ahvaz, Khuzestan, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3320 9238
Email
ftjhanbyn23@gmail.com
Web page address
https://ajums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be available after the completion of the thesis and the publication of the article.
When the data will become available and for how long
One week after the completion of the thesis and the publication of the article.
To whom data/document is available
Ahvaz Jundishapur University of Medical Sciences and all associated researchers Hospitals, clinics, and universities.
Under which criteria data/document could be used
“Data will be made available to others following the analysis, through publication in scientific-research journals.”
From where data/document is obtainable
Effat Jahanbin.ftjhanbyn23@gmail.com
What processes are involved for a request to access data/document
“Requests can be submitted via email, and a response will be provided within 7 to 10 days