- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401810
Fascial Yoga in Menopausal Women (FascialYogaM)
The Effect of Fascial Yoga on Perceived Stress, Cognitive Control, and Cognitive Flexibility in Menopausal Women
Aim:
The aim of this study is to evaluate the effects of a structured fascial yoga-based behavioral intervention on perceived stress, cognitive control, and cognitive flexibility in menopausal women. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce perceived stress in menopausal women.
Design:
This study is designed as a randomized controlled, pretest-posttest experimental study with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either the intervention group or the control group receiving usual care. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention.
Method:
A total of 100 menopausal women aged 45-65 years will be recruited from the menopause outpatient clinic and randomly assigned to either the intervention group or the control group. The intervention group will participate in a 12-week online fascial yoga program consisting of two 60-minute sessions per week.
In this study, fascial yoga is defined as a fascia-focused, non-pharmacological, and non-invasive behavioral intervention that includes myofascial release techniques, breath regulation, body awareness, and basic yoga practices to support stress regulation and cognitive functioning. The program will include myofascial release techniques, basic yoga postures suitable for all physical fitness levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken.
The control group will continue to receive routine outpatient care during the study period. After completion of the follow-up assessments, the fascial yoga program will be offered to participants in the control group upon request.
Data will be collected at three time points: at baseline before the intervention, immediately after completion of the 12-week intervention, and at the follow-up assessment 8 weeks after the intervention. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires.
Hypotheses:
H1: Menopausal women participating in the fascial yoga intervention will show a significant reduction in perceived stress levels compared with the control group at post-intervention and follow-up assessments.
H2: Menopausal women participating in the fascial yoga intervention will show a significant improvement in cognitive control and cognitive flexibility compared with the control group at post-intervention and follow-up assessments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayşe Eminoğlu, RN, MSc, PhD Candidate
- Phone Number: +905415998795
- Email: ayse.eminoglu@marmara.edu.tr
Study Contact Backup
- Name: Semra Karaca, PhD
- Phone Number: +905523050273
- Email: sckaraca@marmara.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female participants aged 45-65 years
- In the menopausal period, defined as at least 12 months since the last menstrual period
- Able to read and understand Turkish and to complete self-report questionnaires
Exclusion Criteria:
- Current or past diagnosis of a psychiatric disorder or ongoing psychiatric treatment
- Regular use of antidepressant, anxiolytic, or corticosteroid medications
- History of cancer or currently receiving active oncological treatment
- Participation in facial yoga or similar yoga-based programs within the past 6 months
- Any medical condition that may prevent safe participation in mild physical activity
- Incomplete attendance to intervention sessions or incomplete outcome data during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
|
|
|
Experimental: Fascial Yoga Intervention
|
A structured 12-week online fascial yoga program consisting of two 60-minute sessions per week.
The intervention focuses on fascial myofascial relaxation, breathing regulation, and body awareness for stress regulation and cognitive functioning.
Sessions will be conducted in a group format, and no audio or video recordings will be taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Level
Time Frame: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
|
Change in perceived stress levels measured using the Perceived Stress Scale (PSS-14).
The scale consists of 14 items rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 56.
Higher scores indicate higher perceived stress levels.
|
Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
|
|
Cognitive Control and Flexibility
Time Frame: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
|
Change in cognitive control and cognitive flexibility levels measured using the Cognitive Control and Flexibility Questionnaire.
The questionnaire consists of two subscales (cognitive control and cognitive flexibility), with items rated on a 7-point Likert scale.
Higher scores indicate better cognitive control and greater cognitive flexibility.
|
Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-SBF-ETIK-206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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