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NCT Number: NCT07737691

Relaxation Training Via Tele-Rehabilitation in Postmenopausal Women

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.

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Key information

About this study

Menopause is defined as the permanent cessation of menstruation for 12 consecutive months and is associated with a wide range of physiological and psychological changes. During the postmenopausal period, women frequently experience menopausal symptoms, including vasomotor, somatic, psychological, and urogenital complaints, as well as sleep disturbances and fatigue. These symptoms may negatively affect daily functioning and overall quality of life.

Non-pharmacological interventions are increasingly recommended for the management of menopausal symptoms because of their safety, accessibility, and potential to improve well-being. Among these interventions, relaxation training has been reported to alleviate menopausal symptoms and improve sleep quality and psychological health. Previous studies have also demonstrated that regular physical activity and exercise-based interventions may reduce symptom severity and improve quality of life in postmenopausal women. However, findings regarding their effects on sleep quality remain inconsistent, highlighting the need for further research using standardized intervention protocols.

Tele-rehabilitation enables healthcare professionals to deliver rehabilitation services remotely using information and communication technologies while maintaining real-time interaction with participants. This approach has become increasingly common following the COVID-19 pandemic and offers several advantages, including improved accessibility, reduced transportation barriers, enhanced treatment adherence, and the opportunity to deliver supervised interventions in participants' home environments. Tele-rehabilitation has been successfully implemented across various rehabilitation fields; however, evidence regarding physiotherapist-supervised relaxation training delivered synchronously via tele-rehabilitation for postmenopausal women remains limited.

The present 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 women during the early postmenopausal period. Thirty eligible participants will be randomly allocated to either an intervention group or a control group. Participants in the intervention group will receive a six-week tele-rehabilitation-based relaxation training program consisting of two supervised sessions per week, whereas participants in the control group will receive no structured intervention during the study period.

Menopausal symptoms will be evaluated using the Menopause Rating Scale (MRS), sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), objective sleep parameters will be monitored using the Sleep Cycle mobile application, and fatigue will be assessed using the Fatigue Severity Scale (FSS). Outcome measures will be collected before and after the six-week intervention.

This study is expected to provide evidence regarding the effectiveness and feasibility of tele-rehabilitation-based relaxation training as a non-pharmacological intervention for improving menopausal symptoms, sleep quality, and fatigue in postmenopausal women. The findings may contribute to the integration of tele-rehabilitation into women's health rehabilitation and support the development of accessible, cost-effective, and sustainable rehabilitation programs for women experiencing menopausal symptoms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index

    Time frame: Baseline and after the 6-week intervention

    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.

Secondary outcomes

  1. Change in App-Based Sleep Quality Score

    Time frame: Nightly throughout the 6-week intervention period

    Sleep will be monitored nightly using the Sleep Cycle mobile application. Participants will start the application before sleep and stop it upon awakening. The sleep quality scores generated by the application will be recorded weekly, and changes over the 6-week intervention period will be evaluated.

  2. Change in Menopausal Symptoms Assessed by the Menopause Rating Scale

    Time frame: Baseline and after the 6-week intervention

    Menopausal symptoms will be assessed using the Menopause Rating Scale (MRS), which consists of 11 items grouped into somatic, psychological, and urogenital subscales. Each item is scored from 0 to 4, and the total score ranges from 0 to 44. Higher scores indicate more severe menopausal symptoms.

  3. Change in Fatigue Severity Assessed by the Fatigue Severity Scale

    Time frame: Baseline and after the 6-week intervention

    Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item self-reported questionnaire. Each item is scored from 1 to 7, and the total score is calculated as the mean of the item scores. Higher scores indicate greater fatigue severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Sinem Okan

CONTACT

[email protected]

İrem Çetinkaya, PhD

CONTACT

[email protected]

5548056805

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

  • Halic University

Registry information

Official study title

Effects of Tele-Rehabilitation-Based Relaxation Training on Menopausal Symptoms, Sleep Quality, and Fatigue in Postmenopausal Women: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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