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

Sponsor
NURDİLAN SENER (Other)
Overall Status
Completed
CT.gov ID
NCT04762095
Collaborator
(none)
113
1
2
21.8
5.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: mindfulness stress reduction program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Research is quasi-experimentalResearch is quasi-experimental
Masking:
Single (Participant)
Masking Description:
Postmenopausal Women
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
Actual Study Start Date :
Mar 29, 2019
Actual Primary Completion Date :
Sep 3, 2019
Actual Study Completion Date :
Jan 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. mindfulness stress reduction program reduces menopausal symptoms [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NURDİLAN Elaziğ Eyalet/Yerleşke Turkey 23100

Sponsors and Collaborators

  • NURDİLAN SENER

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NURDİLAN SENER, phd research assistant, Firat University
ClinicalTrials.gov Identifier:
NCT04762095
Other Study ID Numbers:
  • Firat
First Posted:
Feb 21, 2021
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 30, 2021