NCT07401810

Brief Summary

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 60 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jul 2026

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 Progress9%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

February 3, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

MenopausePerceived StressCognitive FlexibilityCognitive ControlYoga

Outcome Measures

Primary Outcomes (2)

  • Perceived Stress Level

    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

    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

Study Arms (2)

Fascial Yoga Intervention

EXPERIMENTAL
Behavioral: Fascial Yoga Program

Usual Care

NO INTERVENTION

Interventions

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.

Fascial Yoga Intervention

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is gender-based because it focuses exclusively on women in the menopausal period, a biological condition that occurs only in females. Eligibility criteria are therefore limited to female participants.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 fascial yoga, yoga, or similar yoga-based programs within the past 6 months
  • Any medical condition that may prevent safe participation in mild physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Ayşe Eminoğlu, RN, MSc, PhD Candidate

CONTACT

Semra Karaca, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share