<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260922071154N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-07</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Effectiveness of Self-Compassion-Based Counseling on the Body Image of Menopausal Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Self-Compassion-Based Counseling on Body Image in Menopausal Women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menopausal state and body image dissatisfaction.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be available after the completion of the thesis and the publication of the article.

When:
One week after the completion of the thesis and the publication of the article.

To whom:
Ahvaz Jundishapur University of Medical Sciences and all associated researchers Hospitals, clinics, and universities.

Conditions:
“Data will be made available to others following the analysis, through publication in scientific-research journals.”

Where to obtain:
Effat Jahanbin.ftjhanbyn23@gmail.com

How to obtain:
“Requests can be submitted via email, and a response will be provided within 7 to 10 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Effat Jahanbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 992 312 1611</telephone>
        <email>ftjhanbyn23@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Javadi-Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3320 9238</telephone>
        <email>nahidjavadifar_341@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N95.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Menopausal and female climacteric states</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-09-13</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan Boulevard, Esfand Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
