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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04762095
Other study ID # Firat
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2019
Est. completion date January 20, 2021

Study information

Verified date November 2021
Source Firat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date January 20, 2021
Est. primary completion date September 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
mindfulness stress reduction program
mindfulness stress reduction program

Locations

Country Name City State
Turkey NURDILAN Elazig Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
NURDILAN SENER

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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