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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762095
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
NURDİLAN SENER, Firat University

Study Description
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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
Postmenopausal Women Other: mindfulness stress reduction program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Research 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 : March 29, 2019
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : January 20, 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04762095


Locations
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Turkey
NURDİLAN
Elaziğ, Eyalet/Yerleşke, Turkey, 23100
Sponsors and Collaborators
NURDİLAN SENER
More Information
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Responsible Party: NURDİLAN SENER, phd research assistant, Firat University
ClinicalTrials.gov Identifier: NCT04762095    
Other Study ID Numbers: Firat
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No