NCT07141953

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 19, 2025

Last Update Submit

August 19, 2025

Conditions

Gynecological OncologyGynecologyOncologySurgical MenopauseSymptom ManagementQuality of LifeSleep QualityWell-beingYogaYoga for Cancer

Keywords

gynecological oncologygynecologyoncologysurgical menopausesymptom managementquality of lifesleep qualitywell-beingyogayoga for cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life with yoga

    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 Outcomes (3)

  • Change in Sleep Quality

    Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)

  • Change in Spiritual Well-Being

    Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)

  • Change in Menopausal Symptoms

    Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)

Study Arms (2)

Study Group

EXPERIMENTAL

Individuals who perform yoga

Behavioral: Yoga

Control Group

NO INTERVENTION

Controls

Interventions

YogaBEHAVIORAL

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.

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Dilek Bilgiç, Prof.

    Dokuz Eylul University

    STUDY DIRECTOR

Central Study Contacts

Selcan Zeynep Ergöz Aksoy, RN. MSc.

CONTACT

+905393692241selcanzeynepergoz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN. MSc.

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

September 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)