MedTrace Logo

Psychosocial Effects of Mindfulness-Based Exercise in Postmenopausal Women

NCT07424521 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-20

No results posted yet for this study

Summary

Menopause is a natural biological process characterized by the permanent cessation of the menstrual cycle in women. Hormonal changes associated with menopause commonly lead to mood swings, anxiety, depression, stress, and decreased sleep quality in women. While the current literature indicates that mindfulness-based interventions offer potential benefits in alleviating psychological and physical symptoms in postmenopausal women, the limited number of studies in the literature and methodological differences suggest a need for more randomized controlled trials in this area. The aim of this study is to examine the effect of mindfulness-based exercises on psychosomatic complaints such as anxiety, depression, and sleep quality in postmenopausal women. Designed as a randomized controlled experimental study, it was planned to include at least 20 women in the early postmenopausal period residing in Istanbul and Izmir between March and June 2026. The women included in the study will be randomized into Group 1 (n=10), which will perform mindfulness-based exercises, and Group 2 (n=10), which will receive no intervention as usual. The STAI I-II Form State and Trait Anxiety Scale and Beck Anxiety Inventory will be used to assess state and anxiety level, the Beck Depression Scale for depression level, and the Pittsburgh Sleep Quality Scale for sleep quality.

Continuous variables will be presented as mean ± standard deviation, and qualitative variables as number and percentage (%). If parametric test assumptions are met, the Independent Samples t-test will be used to compare independent groups, and the Paired Samples t-test will be used to compare dependent groups. If parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent groups, and the Wilcoxon test will be used to compare dependent groups. Statistical significance will be set at p≤0.05. This study is expected to contribute to the literature by providing evidence-based data on the effectiveness of mindfulness-based exercises on common psychological symptoms in the postmenopausal period.

Conditions

  • Psychosocial Functioning
  • Mindfulness
  • Postmenopausal Symptoms

Interventions

OTHER

Mindfulness-Based Stress Reduction Training

Participants will be asked to attend standard group classes for one hour, six days a week. Meditation-based techniques will include breathing exercises, sitting meditations, and body scans. In week 6 of the program, individuals will undergo an eight-hour retreat, and will continue with the standard exercises for the remaining weeks. The goal of practicing mindfulness-based techniques daily is to ensure their effectiveness as a sustainable, lifelong intervention.

Sponsors & Collaborators

  • Halic University

    lead OTHER

Principal Investigators

  • İrem Çetinkaya, PhD · Haliç University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-05-01
Completion
2026-06-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424521 on ClinicalTrials.gov