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

NCT ID: NCT04762095

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-29

Study Completion Date

2021-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Research is quasi-experimental
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Postmenopausal Women

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Effect of mindfulness stress reduction program Quality of Life

mindfulness stress reduction program reduces menopausal complaints.

Group Type EXPERIMENTAL

mindfulness stress reduction program

Intervention Type OTHER

mindfulness stress reduction program

The Effect of mindfulness stress reduction program Menopausal Symptoms

mindfulness stress reduction program improves the quality of life of women in the menopausal period.

Group Type EXPERIMENTAL

mindfulness stress reduction program

Intervention Type OTHER

mindfulness stress reduction program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mindfulness stress reduction program

mindfulness stress reduction program

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NURDİLAN SENER

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NURDİLAN SENER

phd research assistant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NURDİLAN

Elâzığ, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Firat

Identifier Type: -

Identifier Source: org_study_id