Yoga in Women With Surgical Menopause After Gynecological Cancer

August 19, 2025 updated by: Selcan Zeynep Ergöz Aksoy, Dokuz Eylul University

The Effect of Yoga on Quality of Life, Sleep Quality, and Spiritual Well-Being in Women Who Undergo Surgical Menopause Following Gynecological Cancer Surgery: A Randomized Controlled Trial

This randomized controlled trial investigates the effects of yoga on quality of life, sleep quality, and spiritual well-being in women who have entered surgical menopause after gynecological cancer surgery. Yoga is expected to be a supportive intervention for symptom management and to improve overall well-being in this patient population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgical menopause after gynecological cancer surgery is associated with sudden and severe symptoms that may reduce quality of life, disturb sleep, and affect overall well-being. Supportive non-pharmacological approaches such as yoga may help manage these challenges.

This randomized controlled trial will investigate the effects of an 8-week yoga program on quality of life, sleep quality, and spiritual well-being in women who have entered surgical menopause. Forty-six participants will be randomly assigned to either a yoga intervention group or a control group. The intervention group will attend two yoga sessions per week (one online, one face-to-face) in small groups or individually with a certified instructor, while the control group will receive usual care and be offered yoga after the study.

Assessments will be conducted at baseline, post-intervention (8 weeks), and 3-month follow-up using standardized questionnaires. It is expected that yoga will support symptom management and improve overall well-being in this patient population.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Balçova
      • Izmir, Balçova, Turkey (Türkiye), 35330
        • Dokuz Eylul University
        • Contact:
        • Principal Investigator:
          • Selcan Zeynep Ergöz Aksoy, RN. MSc.
        • Sub-Investigator:
          • Dilek Bilgiç, Prof.
        • Sub-Investigator:
          • Nuri Yıldırım, Assoc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age between 18-65 years Diagnosis of primary gynecological cancer (ovarian, endometrial, cervical, vaginal, or vulvar) (Stage I-III) Ability to read, understand, and speak Turkish Completion of all adjuvant treatments (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior Access to the internet Having a computer/tablet/phone with a camera Willingness and ability to attend at least 80% of the yoga sessions Voluntary participation in the study

Exclusion Criteria:

Any condition that prevents communication Cognitive, sensory, or physical impairment that prevents yoga practice Diagnosis of metastatic gynecological cancer Regular yoga practice within the last 6 months (at least once a week for 8 consecutive weeks)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Individuals who perform yoga
Behavioral: Yoga
Participants in the intervention group will take part in an 8-week yoga program designed for women who have entered surgical menopause after gynecological cancer surgery. The program will consist of two 60-minute sessions per week, one delivered online and one delivered face-to-face, conducted in small groups (5-6 participants) or individually, depending on participant availability. The sessions will include physical postures, breathing exercises, and relaxation/meditation techniques. The program will be delivered by a certified yoga instructor.
No Intervention: Control Group
Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life with yoga
Time Frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in WHOQOL-BREF total score. Scores range 0-100; higher scores indicate better quality of life.
Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Quality
Time Frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate worse sleep quality.
Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Spiritual Well-Being
Time Frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in FACIT-Sp-12 total score. Higher scores indicate greater spiritual well-being.
Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Menopausal Symptoms
Time Frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Menopause Rating Scale total score. Higher scores indicate greater symptom burden.
Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Investigators

  • Study Director: Dilek Bilgiç, Prof., Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Estimated)

August 26, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEU-2025/12-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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