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Completed

NCT Number: NCT04762095

The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life

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).

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Key information

Conditions

Postmenopausal Women

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NURDİLAN

Elâzığ, Eyalet/Yerleşke, 23100, Turkey (Türkiye)

About this study

Aim: 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.

Materials and Methods: Research is quasi-experimental. 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). In the study, an 8-week Mindfulness Stress Reduction Program was applied to the women in the experimental group. In the study, mid-test and post-test (MAAS, MSAS, MYQOL) were applied 8 and 16 weeks after the pre-test. Descriptive statistics, independent groups t test, chi-square test, ANOVA, Mauchly's test and Cronbach Alpha analysis were used to evaluate the data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Being in menopause

  • Not having any diagnosed psychiatric disease or using medication,
  • Not using or not using hormone replacement therapy.

Exclusion criteria

  • Having entered menopause with surgical methods,
  • Not attending at least two group programs.

Treatment and study plan

mindfulness stress reduction program

Other

mindfulness stress reduction program

Primary outcomes

  1. mindfulness stress reduction program reduces menopausal symptoms

    Time frame: UP TO 16 WEEKS

    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.

  2. Mindfulness stress reduction program improves quality of life

    Time frame: UP TO 16 WEEKS

    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.

Sponsors and collaborators

Lead sponsor

NURDİLAN SENER

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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