Facial Yoga in Menopausal Women

NCT07401810 | Not Yet Recruiting

• 1 other identifier: MU-SBF-ETIK-206
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Menopause; Stress, Psychological; Cortisol; Cognitive Flexibility; Nonpharmacological Interventions; Randomized Controlled Trial; Cognitive Control; Perceived Stress; Yoga

Keywords

Menopause; Perceived Stress; Cognitive Flexibility; Cognitive Control; Yoga; Cortisol; Saliva

Outcome Measures

Primary Outcomes (3)

• 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

• Salivary Cortisol Level

  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

  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)

Facial Yoga Intervention

EXPERIMENTAL

Behavioral: Facial Yoga Program

Usual Care

NO INTERVENTION

Interventions

Facial Yoga Program BEHAVIORAL

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.

Facial Yoga Intervention

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: This 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 Volunteers: Yes
• Age Groups: Adult (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 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

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Ayşe Eminoğlu, RN, MSc, PhD Candidate

CONTACT

+905415998795; ayse.eminoglu@marmara.edu.tr

Semra Karaca, PhD

CONTACT

+905523050273; sckaraca@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• 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: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share