Menopausal; CrisisNCT06942169
Mindfulness-Based Self-Compassion Training for Menopausal Women
A study testing Mindfulness-Based Self-Compassion Training in people with Menopausal; Crisis and Self-Compassion, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Menopausal; Crisis, Self-Compassion, Image, Body
- What is being tested?
- Mindfulness-Based Self-Compassion Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Menopausal; Crisis, Self-Compassion, Image, Body, Anger
- Being tested
- Mindfulness-Based Self-Compassion Training
- Keywords
- Self-Compassion, anger, Menopause, Image, Body, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Self-Compassion TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Self-Compassion Training |
| No intervention | No intervention | No intervention was applied to menopausal women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and after 8 weeks
Secondary outcomes (1)
DSM-V Level 2 Anger Scale
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.
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Jun 2024
- Primary completion15 Jun 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Menopausal; CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was executed in the form of a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysel AKBENIZ, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942169
- Sponsor's protocol ID
- 2023/4613
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 36133626Algars 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.
PubMed 24360136de 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.
PubMed 29095126Guest 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.
PubMed 31077956Handy 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.
PubMed 35267252Kim 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.
PubMed 26154274Akbeniz A, Sabanci Baransel E. The effect of mindfulness-based stress reduction training on fear of childbirth and psychological well-being in women experiencing premenstrual syndrome: a randomized controlled trial. Arch Womens Ment Health. 2026 Jun 19;29(4):97. doi: 10.1007/s00737-026-01737-8.
PubMed 42319498
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness-Based Self-Compassion Training for Menopausal Women on Their Genital Self-Image and Self-Anger
- ClinicalTrials.gov ID
- NCT06942169
- Acronym / sponsor ID
- 2023/4613
- Conditions
- Menopausal; Crisis, Self-Compassion, Image, Body, Anger
- Keywords
- Self-Compassion, anger, Menopause, Image, Body, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was executed in the form of a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Self-Compassion Training | Experimental | Behavioral: Mindfulness-Based Self-Compassion TrainingMindfulness-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. |
| No intervention | No intervention | –No intervention was applied to menopausal women in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Self-Compassion TrainingMindfulness-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. | Behavioural | Mindfulness-Based Self-Compassion Training |
Primary outcome
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.
1 secondary outcome
DSM-V Level 2 Anger Scale
Time frame: baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 36133626Crego 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.
- Results publication: PubMed 24360136Algars 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.
- Results publication: PubMed 29095126de 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.
- Results publication: PubMed 31077956Guest 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.
- Results publication: PubMed 35267252Handy 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.
- Results publication: PubMed 26154274Kim 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.
- Derived from this study: PubMed 42319498Akbeniz A, Sabanci Baransel E. The effect of mindfulness-based stress reduction training on fear of childbirth and psychological well-being in women experiencing premenstrual syndrome: a randomized controlled trial. Arch Womens Ment Health. 2026 Jun 19;29(4):97. doi: 10.1007/s00737-026-01737-8.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Self-Compassion Training in people with Menopausal; Crisis and Self-Compassion, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Genital Self-Image Scale (FGSIS) (time frame: baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06942169, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.