Relaxation Training Via Tele-Rehabilitation in Postmenopausal Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Relaxation Training Delivered via Tele-Rehabilitation
Other interventionParticipants 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and after the 6-week interventionSecondary outcomes
1
Change in App-Based Sleep Quality Score
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.
Time frame
Nightly throughout the 6-week intervention period2
Change in Menopausal Symptoms Assessed by the Menopause Rating Scale
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.
Time frame
Baseline and after the 6-week intervention3
Change in Fatigue Severity Assessed by the Fatigue Severity Scale
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.
Time frame
Baseline and after the 6-week interventionLocations
Sponsors and contacts
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Marmara University
Lead sponsor
Halic University
Collaborator
Source ClinicalTrials.gov
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