The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
1 other identifier
interventional
113
1 country
1
Brief Summary
The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedNovember 30, 2021
November 1, 2021
5 months
February 13, 2021
November 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
mindfulness stress reduction program reduces menopausal symptoms
Menopause Rating Scale is an 11 item scale.The five-point Likert type scale has three sub-dimensions.The higher the scores of each item, the higher the complaints, the higher the total score of the scale, the higher the menopausal complaints.
UP TO 16 WEEKS
Mindfulness stress reduction program improves quality of life
Menopausal Quality of Life Scale is a Likert-type scale with 29 questions and consists of four domains: vasomotor, psychosocial, physical and sexual. Each question score is from 0 to 6. The increase in the scale score indicates that the severity of the complaints increased.
UP TO 16 WEEKS
Study Arms (2)
The Effect of mindfulness stress reduction program Quality of Life
EXPERIMENTALmindfulness stress reduction program reduces menopausal complaints.
The Effect of mindfulness stress reduction program Menopausal Symptoms
EXPERIMENTALmindfulness stress reduction program improves the quality of life of women in the menopausal period.
Interventions
mindfulness stress reduction program
Eligibility Criteria
You may qualify if:
- Being in menopause
- Not having any diagnosed psychiatric disease or using medication,
- Not using or not using hormone replacement therapy.
You may not qualify if:
- Having entered menopause with surgical methods,
- Not attending at least two group programs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NURDİLAN SENERlead
Study Sites (1)
NURDİLAN
Elâzığ, Eyalet/Yerleşke, 23100, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Postmenopausal Women
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- phd research assistant
Study Record Dates
First Submitted
February 13, 2021
First Posted
February 21, 2021
Study Start
March 29, 2019
Primary Completion
September 3, 2019
Study Completion
January 20, 2021
Last Updated
November 30, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share