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Yoga in Women With Surgical Menopause After Gynecological Cancer

Not Applicable
Not yet recruiting
Conditions
Gynecological Oncology
Gynecology
Oncology
Surgical Menopause
Symptom Management
Quality of Life
Sleep Quality
Well-being
Yoga
Yoga for Cancer
Registration Number
NCT07141953
Lead Sponsor
Dokuz Eylul University
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.

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
46
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Quality of Life with yogaBaseline, 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.

Secondary Outcome Measures
NameTimeMethod
Change in Sleep QualityBaseline, 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.

Change in Menopausal SymptomsBaseline, 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.

Change in Spiritual Well-BeingBaseline, 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.

Trial Locations

Locations (1)

Dokuz Eylul University

Izmir, Balçova, Turkey (Türkiye)

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

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