NCT07728461

Brief Summary

Menopause is a natural stage in a woman's life characterized by the permanent cessation of ovarian function and is frequently accompanied by vasomotor, psychological, urogenital, and sleep-related symptoms that can substantially impair quality of life. Although pharmacological treatments are available, many women seek non-pharmacological interventions to manage menopausal symptoms and improve their overall well-being. Mindfulness- and compassion-based interventions have shown promising effects on psychological health, stress reduction, and quality of life in different populations; however, evidence regarding the effectiveness of Mindfulness-Based Compassionate Living (MBCL) for women experiencing menopause remains limited. This randomized controlled trial aims to evaluate the effectiveness of a Compassionate Living Education Program based on the principles of Mindfulness-Based Compassionate Living in improving symptom management and quality of life among menopausal women. The study will be conducted with menopausal women recruited from primary healthcare settings in Kars, Türkiye. Participants who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive an eight-session online Compassionate Living Education Program delivered by a certified instructor. The program includes mindfulness practices, self-compassion exercises, breathing and relaxation techniques, compassionate imagery, loving-kindness meditation, and home practice assignments designed to strengthen emotional regulation, self-kindness, and adaptive coping skills. The control group will receive routine care only. Primary outcomes will include menopausal symptom severity and menopause-specific quality of life. Secondary outcomes will include self-compassion, mindfulness, anxiety, depression, and stress. Data will be collected using validated self-report questionnaires before and after the intervention and analyzed using appropriate statistical methods. The findings of this study are expected to provide evidence regarding the effectiveness of Compassionate Living Education as an accessible, low-cost, non-pharmacological intervention for improving symptom management and enhancing the quality of life of menopausal women. The results may contribute to the development of evidence-based nursing and women's health interventions in primary healthcare settings.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

mindfulnessself-compassionQuality of lifeMenopauseWomen

Outcome Measures

Primary Outcomes (1)

  • Menopausal Symptom Assessment Scale/MSSA (Appendix-2)

    Developed by Schneider et al. in 1992 to measure the severity of menopausal symptoms and their impact on quality of life, the Turkish validity and reliability of this scale was established by Gürkan (Gürkan, 2005). The scale, consisting of 11 items covering menopausal complaints, comprises 3 sub-dimensions: 1- Somatic complaints (items 1, 2, 3, 11), 2- Psychological complaints (items 4, 5, 6, 7), and 3- Urogenital complaints (items 8, 9, 10). The scale uses a 5-point Likert scale, with each item scored from 0: None, 1: Mild, 2: Moderate, 3: Severe, and 4: Very severe. The total score of the scale is calculated based on the scores given for each item. The minimum score obtainable from the scale is 0, while the maximum score is 44. An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced, and on the other hand, it shows that the quality of life is negatively affected.

    up to 1 day

Secondary Outcomes (1)

  • Menopause-Specific Quality of Life Scale (MSQLS) (Appendix-3)

    up to 1 day

Other Outcomes (2)

  • Self-Compassion Scale Short Form (SCS-S) (Appendix-4)

    up to 1 day

  • Mindfulness Awareness Scale (MAS) (Appendix-5)

    up to 1 day

Study Arms (8)

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

EXPERIMENTAL

• A "breath break with kindness" is practiced. • Encourage them to think about how threat, impulse and sedative systems have developed in their own lives. • A "safe place" application is made. • "Courtesy meditation" is done.

Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

Session 2: Threat and Self-Compassion

EXPERIMENTAL

• A "breath break with kindness" is practiced. • "Building a compassionate relationship with resilience" and "kindness meditation: a benevolent" practices are made. • "A hand on your heart" and "a compassionate comrade" practices are made.

Behavioral: Session 2: Threat and Self-Compassion

Session 3: Unraveling the Knots of Desire and Patterns Agenda

EXPERIMENTAL

• Talk about homework. • A "breath break with kindness" is practiced. • "Establishing a compassionate relationship with desire", "guided meditation to discover the inner pattern", "courtesy meditation: a good friend" practices are made.

Behavioral: Session 3: Unraveling the Knots of Desire and Patterns

Session 4: Internalizing compassion

EXPERIMENTAL

• "Pretend-to-pretend" practice is made for participants to observe themselves. • In addition to the previous practices, the practice of "internalizing compassion" is made in order to increase their expanded mindfulness. • Courtesy meditation: a neutral person", "kindness towards your body", which is based on mindfulness practices and increases body awareness and mindful movement, is carried out. During the day, they will be informed that they should do the "walking with kindness" practice on their own.

Behavioral: Session 4: Internalizing compassion

Session 5: Me and others - Expanding the circle

EXPERIMENTAL

• A "compassionate letter" application is made by asking participants to think about a situation they encountered recently or some time ago and is still causing distress. It is explained that they can gain insight with this application. • "Courtesy meditation: the 'difficult' person", "compassion and breathing: yourself" and "compassionate breathing: others" practices are made

Behavioral: Session 5: Me and others - Expanding the circle

Session 6: Growing happiness

EXPERIMENTAL

• "Revisiting the good" practice is carried out to define the five sense organs for the participants. • "Forgiveness", "Asking for forgiveness", "forgiving others", "gratitude" practices are carried out. • The practice is expanded as "kindness meditation: groups and all beings".

Behavioral: Session 6: Growing happiness

Session 7: Weaving Wisdom and Compassion into Daily Life

EXPERIMENTAL

• Participants are made to choose a day in their life and allow a few minutes to pause in a mindful way. • "A breather for wise and compassionate action", "calmness meditation" and "joy sharing meditation" practices are carried out.

Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life

Session 8: Living with the Heart

EXPERIMENTAL

• The participants are told about the applications that they can apply for, where they need help to develop compassion towards self-healing skills, and the whole training is evaluated. • The "river of life" application, which evaluates mindfulness in depth, is carried out. • An overall summary of the 8-session study is made and feedback is received.

Behavioral: Session 8: Living with the Heart

Interventions

The practice of "Breath break with kindness" will be applied for 5 minutes. Afterwards, 15 minutes of information on threats, impulses and soothing systems, "A safe place" application for 11 minutes, "Courtesy meditation" for 10 minutes. After each application, 10 minutes of feedback will be received from the participants.

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

The practice of "breathing with kindness" will be done for 7 minutes. The practice of "Building a compassionate relationship with resilience" will be held for 12 minutes, and the practice of "Kindness meditation: a benevolent" will take place for 11 minutes. "A hand over your heart" application will be made for 3 minutes and "A compassionate comrade" application will be done for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 2: Threat and Self-Compassion

The practice of "breathing with kindness" will be done for 7 minutes. "Building a compassionate relationship with desire" 12 minutes, "Guided meditation to discover the inner pattern" 10 minutes and "Courtesy meditation: a good friend" 11 minutes. Except for the "breath break with kindness" application, 3 minutes of feedback will be received from the participants after each application

Session 3: Unraveling the Knots of Desire and Patterns Agenda

The "pretend-to-be" practice for the participants to observe themselves will be made for 10 minutes. The practice of "internalizing compassion" will be done for 7 minutes, "kindness meditation: a neutral person" practice for 10 minutes, and "kindness towards your body" for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 4: Internalizing compassion

The "a compassionate letter" practice with the participants will continue for 15 minutes. "meditation: the 'difficult' person" 8 minutes, "compassion and breathing: yourself" 10 minutes and "compassionate breathing: others" 7 minutes. A "compassionate break" application is performed for 7 minutes.

Session 5: Me and others - Expanding the circle

The practice of "Revisiting the good" is carried out for 10 minutes with the participants. "Forgive yourself", "wish for forgiveness", "forgive others", "gratitude" practices will be held for 5 minutes each and will take 20 minutes in total. "Courtesy meditation: groups and all beings" will be practiced for 10 minutes. After each application, 3 minutes of feedback will be received from the participants

Session 6: Growing happiness

Participants will be given 10 minutes to choose a day in their life and allow a few minutes to pause mindfully. The practice of "a breather for wise and compassionate action" is 10 minutes, the practice of "calmness meditation" is 8 minutes, and the practice of "sharing the joy meditation" is 8 minutes. After each application, 3 minutes of feedback will be received from the participants.

Session 7: Weaving Wisdom and Compassion into Daily Life

The participants are told about the applications they can apply for, where they need help to develop compassion towards self-healing skills, and the entire training will be evaluated for 20 minutes. The "river of life" application is carried out for 20 minutes. 10 minutes of feedback will be received after the application.

Session 8: Living with the Heart

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenopausal women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women who are in the menopausal period.
  • Aged 45 years or older.
  • Registered at the participating primary healthcare center.
  • Able to read and understand Turkish.
  • At least a primary school graduate.
  • Willing to participate and provide written informed consent.
  • Able to attend the online Compassionate Living Education sessions.
  • Able to complete the study questionnaires.

You may not qualify if:

  • Failure to complete the study questionnaires.
  • Failure to attend the Compassionate Living Education sessions.
  • Withdrawal of informed consent at any stage of the study.
  • Inability to complete the post-intervention assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Vocational School of Health Services

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Central Study Contacts

Mine Cengiz, lecturer doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Physician

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations