NCT06942169

Brief Summary

This study was conducted to determine the effects of mindfulness-based self-compassion training for menopausal women on their genital self-image and self-anger. Materials and Methods: This study was randomized with 126 menopausal women (study group n=63, control group n=63) between June 2024 and February 2025. Mindfulness-Based Self-Compassion Training (MBSCT) was applied in groups of 10 and 11 participants, twice a week, for 8 sessions of 40 minutes. Data were obtained using the Personal Information Form, Female Genital Self-Image Scale (FGSIS), and DSM-V Level II Anger Scale. Research Hypotheses: H1: MBSCT applied to menopausal women enhances the genital self-image of individuals. H2: MBSCT applied to menopausal women reduces individuals' self-anger.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 8, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

Self-CompassionangerMenopauseImage, Bodymindfulness

Outcome Measures

Primary Outcomes (1)

  • Female Genital Self-Image Scale (FGSIS)

    The Female Genital Self-Image Scale (FGSIS) was developed by Herbenick and Reece (2010) in the United States to measure women's genital self-perceptions.

    baseline and after 8 weeks

Secondary Outcomes (1)

  • DSM-V Level 2 Anger Scale

    baseline and after 8 weeks

Study Arms (2)

Mindfulness-Based Self-Compassion Training

EXPERIMENTAL

Mindfulness-Based Self-Compassion Training is a very comprehensive approach that addresses the awareness and acceptance of individuals towards their bodies, as well as encouraging them to live a conscious life. Studies found that self-compassion increases well-being during menopause.

Behavioral: Mindfulness-Based Self-Compassion Training

No intervention

NO INTERVENTION

No intervention was applied to menopausal women in the control group.

Interventions

Mindfulness-Based Self-Compassion Training is a very comprehensive approach that addresses the awareness and acceptance of individuals towards their bodies, as well as encouraging them to live a conscious life. Studies found that self-compassion increases well-being during menopause (Brown, 2015; Arab et al., 2020). Psychiatric nursing is a special field that works to evaluate, diagnose, and enhance mental health in every area where people are present.

Mindfulness-Based Self-Compassion Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 45 and 70 years old
  • Having no hearing problems
  • Being at menopause in the last year
  • Having no psychiatric illness
  • Having natural menopause
  • Not receiving hormone replacement therapy.

You may not qualify if:

  • Those who did not attend two or more training sessions during the study were excluded from the study.
  • Those who entered menopause surgically and received hormone/replacement therapy during the process were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Center

Malatya, Turkey (Türkiye)

Location

Related Publications (6)

  • Crego A, Yela JR, Riesco-Matias P, Gomez-Martinez MA, Vicente-Arruebarrena A. The Benefits of Self-Compassion in Mental Health Professionals: A Systematic Review of Empirical Research. Psychol Res Behav Manag. 2022 Sep 14;15:2599-2620. doi: 10.2147/PRBM.S359382. eCollection 2022.

    PMID: 36133626BACKGROUND
  • Algars M, Huang L, Von Holle AF, Peat CM, Thornton LM, Lichtenstein P, Bulik CM. Binge eating and menstrual dysfunction. J Psychosom Res. 2014 Jan;76(1):19-22. doi: 10.1016/j.jpsychores.2013.11.011. Epub 2013 Nov 28.

  • de Salis I, Owen-Smith A, Donovan JL, Lawlor DA. Experiencing menopause in the UK: The interrelated narratives of normality, distress, and transformation. J Women Aging. 2018 Nov-Dec;30(6):520-540. doi: 10.1080/08952841.2018.1396783. Epub 2017 Nov 2.

  • Guest E, Costa B, Williamson H, Meyrick J, Halliwell E, Harcourt D. The effectiveness of interventions aiming to promote positive body image in adults: A systematic review. Body Image. 2019 Sep;30:10-25. doi: 10.1016/j.bodyim.2019.04.002. Epub 2019 May 9.

  • Handy AB, Greenfield SF, Yonkers KA, Payne LA. Psychiatric Symptoms Across the Menstrual Cycle in Adult Women: A Comprehensive Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):100-117. doi: 10.1097/HRP.0000000000000329.

  • Kim MK, Ahn CW, Nam JS, Kang S, Park JS, Kim KR. Association between nonalcoholic fatty liver disease and coronary artery calcification in postmenopausal women. Menopause. 2015 Dec;22(12):1323-7. doi: 10.1097/GME.0000000000000503.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor did not know whose study or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was executed in the form of a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 24, 2025

Study Start

June 15, 2024

Primary Completion

June 15, 2024

Study Completion

February 15, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

To conduct the study, approval was obtained from the Scientific Research and Publication Ethics Committee of XXX University (APPROV NO: 2023/4613) and legal permission was obtained from the institutions where the study would be conducted. The purpose of the study was explained to the patients included in the study and their questions were answered. It was explained to the patients that the information they provided would be kept confidential, would not be used anywhere else, and that they had the right to withdraw from the study at any time. Before starting the study, the purpose of the study was explained to the patients and their relatives, and their verbal and written permissions were obtained.

Shared Documents
ICF
Time Frame
Before starting the study, the purpose of the study was explained to the patients and their relatives, and their verbal and written permissions were obtained.
Access Criteria
ANYONE PARTICIPATING IN THE RESEARCH WILL BE ABLE TO ACCESS IT.

Available IPD Datasets

Informed Consent Form Access

Locations