Facial Yoga in Menopausal Women (FacialYogaM)

February 3, 2026 updated by: Ayşe Eminoğlu, Marmara University

The Effect of Facial Yoga Practice on Perceived Stress, Cognitive Control, Cognitive Flexibility, and Cortisol Levels in Menopausal Women

Purpose: The purpose of this study is to evaluate the effects of a structured facial yoga-based behavioral intervention on perceived stress, cognitive control, cognitive flexibility, and salivary cortisol levels in women during the menopausal period. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce biological stress responses in menopausal women.

Design: This study is designed as a randomized, controlled, pretest-posttest experimental trial with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either an intervention group or a control (usual care) group. 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 a menopause outpatient clinic and randomly allocated to either the intervention group or the control group. The intervention group will participate in a 12-week online facial yoga program consisting of two 60-minute sessions per week.

In this study, facial yoga refers to a non-pharmacological and non-invasive behavioral intervention focusing on facial myofascial relaxation, breathing regulation, and body awareness for stress regulation and cognitive functioning. The program will include facial myofascial relaxation techniques, basic yoga postures suitable for all physical 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 and will be offered the facial yoga program after the completion of follow-up assessments, upon request.

Data will be collected at three time points: at baseline prior to the intervention, immediately after completion of the 12-week intervention, and at 8 weeks following the intervention as a follow-up assessment. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires. Salivary cortisol samples will be collected under standardized morning conditions at each assessment point to evaluate biological stress response.

Hypotheses:

H1: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in perceived stress levels compared to the control group at post-intervention and follow-up assessments.

H2: Menopausal women participating in the facial yoga intervention will demonstrate a significant reduction in salivary cortisol levels compared to the control group at post-intervention and follow-up assessments.

H3: Menopausal women participating in the facial yoga intervention will demonstrate a significant improvement in cognitive control and cognitive flexibility compared to the control group at post-intervention and follow-up assessments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Experimental: Facial Yoga Intervention
Behavioral: Facial Yoga Program
A structured 12-week online facial yoga program consisting of two 60-minute sessions per week. The intervention focuses on facial 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Salivary Cortisol Level
Time Frame: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
Change in salivary cortisol levels measured from morning saliva samples collected under standardized conditions.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MU-SBF-ETIK-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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