Menopausal Syndrome, Menopause, Postmenopausal Symptoms, Relaxation Training, Telerehabilitation
Conditions
Keywords
Postmenopause, Telerehabilitation, Relaxation training, Menopausal symptoms, Fatigue
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.
Detailed description
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.
Interventions
OTHERRelaxation Training Delivered via Tele-Rehabilitation
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.
Sponsors
Marmara University
Halic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in App-Based Sleep Quality Score | 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. |
| Change in Menopausal Symptoms Assessed by the Menopause Rating Scale | 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. |
| Change in Fatigue Severity Assessed by the Fatigue Severity Scale | 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. |
Contacts
CONTACTİrem Çetinkaya, PhD
CONTACTSinem Okan
PRINCIPAL_INVESTIGATORİrem Çetinkaya, PhD
Marmara University
Outcome results
None listed