Gynecological OncologyNCT07141953
Yoga in Women With Surgical Menopause After Gynecological Cancer
A study testing Yoga in people with Gynecological Oncology and Gynecology, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gynecological Oncology, Gynecology, Oncology
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Dokuz Eylul University
Izmir, Balçova, 35330
Selcan Zeynep Ergöz Aksoy, RN. MSc., +905393692241, selcanzeynepergoz@gmail.com
Selcan Zeynep Ergöz Aksoy, RN. MSc.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecological Oncology, Gynecology, Oncology, Surgical Menopause, Symptom Management, Quality of Life
- Being tested
- Yoga
- Keywords
- gynecological oncology, gynecology, oncology, surgical menopause, symptom management, quality of life, sleep quality, well-being, yoga, yoga for cancer
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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 | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Individuals who perform yoga Receives: Behavioral: Yoga |
| Control Group | No intervention | Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life with yoga
Change in WHOQOL-BREF total score. Scores range 0-100; higher scores indicate better quality of life.
Measured: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Secondary outcomes (3)
Change in Sleep Quality
Change in Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate worse sleep quality.
Measured: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Spiritual Well-Being
Change in FACIT-Sp-12 total score. Higher scores indicate greater spiritual well-being.
Measured: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in Menopausal Symptoms
Change in Menopause Rating Scale total score. Higher scores indicate greater symptom burden.
Measured: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Zeynep Ergöz Aksoy, Dokuz Eylul University
- Investigators
- Dilek Bilgiç, Prof., Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141953
- Sponsor's protocol ID
- DEU-2025/12-14
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07141953
- Acronym / sponsor ID
- DEU-2025/12-14
- Conditions
- Gynecological Oncology, Gynecology, Oncology, Surgical Menopause, Symptom Management, Quality of Life
- Keywords
- gynecological oncology, gynecology, oncology, surgical menopause, symptom management, quality of life, sleep quality, well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: YogaIndividuals who perform yoga |
| Control Group | No intervention | –Controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaParticipants 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. | Behavioural | Study Group |
Primary outcome
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.
3 secondary outcomes
Change in Sleep Quality
Time frame: 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 Menopausal Symptoms
Time frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilek Bilgiç, Prof. study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Gynecological Oncology and Gynecology, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selcan Zeynep Ergöz Aksoy, RN. MSc. (+905393692241, selcanzeynepergoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life with yoga (time frame: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.