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

Postmenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762095
• Other study ID #: Firat
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Postmenopausal Women

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