- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942169
Mindfulness-Based Self-Compassion Training for Menopausal Women
The Effects of Mindfulness-Based Self-Compassion Training for Menopausal Women on Their Genital Self-Image and Self-Anger
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The menopausal period is a period of physical and mental changes in which the body enters the aging process and the functionality of the genital organs decreases. During this period, women face negative body image, low genital self-image, and inadequate sexual functions. Perceived negative body image can lead to consequences such as low genital self-image and sexual dissatisfaction.
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 . Psychiatric nursing is a special field that works to evaluate, diagnose, and enhance mental health in every area where people are present. However, midwifery has a wide service area with the priority of preventive health services; primarily women's health, and the duties of evaluating, diagnosing, enhancing, and rehabilitating the physical and psychological health of the whole family. In light of this information, increasing the mindfulness and self-compassion levels of women in menopause may increase the place of women who "age" healthily and therefore mentally healthy elderly women, in society and may make a significant contribution to protecting and improving the mental health of society. Since the literature review revealed a gap in the literature regarding these areas for women in the menopausal period, 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey
- Family Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness-Based Self-Compassion Training
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.
|
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.
|
|
No Intervention: No intervention
No intervention was applied to menopausal women in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female Genital Self-Image Scale (FGSIS)
Time Frame: baseline and after 8 weeks
|
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.
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baseline and after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DSM-V Level 2 Anger Scale
Time Frame: baseline and after 8 weeks
|
The Turkish validity and reliability of the Level II Anger Scale prepared by the American Psychiatric Association for DSM-V was conducted by Çöldür et al. (2017).
The DSM-V Level II Anger Scale is a five-item self-report scale used to measure the level of self-anger in adults and provides a practical measurement.
Each item asks the individual to rate the severity of their anger at themselves over the last 7 days.
Scale scoring ranges from 5 to 25.
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baseline and after 8 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/4613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Study Data/Documents
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Informed Consent Form
Information comments:
Informed consent is the process by which a patient freely and consciously gives consent after receiving sufficient information about the medical procedure, treatment or intervention to be applied to him/her.
The written form of this process is the Informed Consent Form.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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