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).

Study Overview

• Status: Completed
• Conditions: Postmenopausal Women
• Intervention / Treatment: Other: mindfulness stress reduction program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyalet/Yerleşke
    • Elaziğ, Eyalet/Yerleşke, Turkey, 23100
      • NURDİLAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Effect of mindfulness stress reduction program Quality of Life; mindfulness stress reduction program reduces menopausal complaints.	Other: mindfulness stress reduction program; mindfulness stress reduction program
Experimental: The Effect of mindfulness stress reduction program Menopausal Symptoms; mindfulness stress reduction program improves the quality of life of women in the menopausal period.	Other: mindfulness stress reduction program; mindfulness stress reduction program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NURDİLAN SENER

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Firat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No