Relaxation Training Via Tele-Rehabilitation in Postmenopausal Women

NCT07737691 | Not Yet Recruiting

• 1 other identifier: karanki11
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Menopause is associated with various physiological and psychological changes that may adversely affect women's quality of life. Menopausal symptoms, sleep disturbances, and fatigue are among the most common complaints during the postmenopausal period. Non-pharmacological interventions, such as relaxation training, have been suggested as effective approaches for managing these symptoms. This randomized controlled trial aims to investigate the effectiveness of a physiotherapist-supervised relaxation training program delivered synchronously via tele-rehabilitation on menopausal symptoms, sleep quality, and fatigue in postmenopausal women. Thirty women in the early postmenopausal period will be randomly assigned to either an intervention group receiving a 6-week tele-rehabilitation-based relaxation training program (twice weekly) or a control group receiving no structured intervention. Outcomes, including menopausal symptoms, sleep quality, objectively monitored sleep parameters, and fatigue, will be assessed before and after the intervention using validated outcome measures. The findings of this study are expected to provide evidence regarding the feasibility and effectiveness of tele-rehabilitation-based relaxation training as a non-pharmacological approach for managing postmenopausal symptoms.

Conditions

Postmenopausal Symptoms; Telerehabilitation; Relaxation Training; Menopause; Menopausal Syndrome

Keywords

Postmenopause; Telerehabilitation; Relaxation training; Menopausal symptoms; Fatigue

Outcome Measures

Primary Outcomes (1)

• Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-reported questionnaire consisting of seven components. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

  Baseline and after the 6-week intervention

Secondary Outcomes (3)

• Change in App-Based Sleep Quality Score

  Nightly throughout the 6-week intervention period

• Change in Menopausal Symptoms Assessed by the Menopause Rating Scale

  Baseline and after the 6-week intervention

• Change in Fatigue Severity Assessed by the Fatigue Severity Scale

  Baseline and after the 6-week intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants assigned to this group will receive a physiotherapist-supervised relaxation training program delivered synchronously via tele-rehabilitation twice weekly for six weeks.

Other: Relaxation Training Delivered via Tele-Rehabilitation

Control group

NO INTERVENTION

Participants assigned to this group will receive no structured intervention during the six-week study period and will continue their usual daily routines. Upon completion of the study, participants will be offered the opportunity to receive the same relaxation training program if desired.

Interventions

Relaxation Training Delivered via Tele-Rehabilitation OTHER

Participants will receive a physiotherapist-supervised relaxation training program delivered synchronously via tele-rehabilitation for six weeks, with two 40-minute sessions per week. Before the intervention, participants will attend a one-hour online orientation session. The program is based on Jacobson's Progressive Muscle Relaxation technique and includes diaphragmatic breathing, systematic contraction and relaxation of major muscle groups, guided relaxation, and imagination exercises. Participants will be instructed to perform brief daily home practice on non-session days. Throughout the intervention, sleep will be monitored nightly using the Sleep Cycle mobile application, and weekly sleep quality scores will be recorded.

Experimental group

Eligibility Criteria

• Gender Eligibility Details: Menopause is a physiological condition that occurs exclusively in women.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women in the early postmenopausal period (within 8 years after menopause) Natural or hormonally confirmed menopause with at least 12 consecutive months of amenorrhea Resident of Tekirdağ Province Able to use a smartphone and internet connection Willing to participate and provide written informed consent

You may not qualify if:

• Presence of a serious cardiac condition, including angina, hypertrophic cardiomyopathy, clinically significant arrhythmia, or a cardiac pacemaker Presence of an advanced orthopedic, neurological, or psychiatric disorder Current use of hormone replacement therapy History of trauma or a medical condition that may prevent participation in the relaxation exercise program Inability to cooperate with or adhere to the study procedures and intervention program

Sponsors & Collaborators

• Marmara University: lead
• Halic University: collaborator

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İrem Çetinkaya, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem Çetinkaya, PhD

CONTACT

5548056805; iremkaranki@gmail.com

Sinem Okan

CONTACT

sinemokan72@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share