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AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Apr 1, 2026
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to evaluate the effectiveness of relaxation and breathing training delivered by a physiotherapist and by an artificial intelligence-assisted system in postmenopausal women with non-specific chronic musculoskeletal pain. Menopause and the postmenopausal period are associated with decreased estrogen levels, structural and functional changes in the musculoskeletal system, increased pain prevalence, reduced muscle function, and impaired quality of life. Relaxation techniques, breathing-focused exercises, and mind-body practices have been shown to reduce pain, improve psychological well-being, and enhance sleep quality. With the growing use of digital health technologies, AI-supported relaxation training may offer personalized guidance, easy accessibility, and sustainable home-based practice, although its effectiveness in postmenopausal women has not yet been demonstrated. In this three-arm randomized controlled trial, participants will be assigned to physiotherapist-led relaxation and breathing training, AI-assisted relaxation and breathing training, or a control group. Interventions will last eight weeks and include sessions three days per week, each approximately 30 minutes. The physiotherapist-guided group will perform sessions face-to-face, while the AI-assisted group will complete prerecorded relaxation and breathing exercises created with AI-generated scripts and voice recordings. The control group will continue daily routines without structured training during the study period. Assessments will be conducted at baseline and at the end of eight weeks. Outcome measures will include pain severity, pressure pain threshold, musculoskeletal symptoms, menopause-specific quality of life, psychological status, sleep quality, dyspnea, and participant satisfaction. The study aims to compare the effects of physiotherapist-led and AI-assisted training modalities on pain, musculoskeletal health, sleep, psychological well-being, and quality of life. Findings are expected to contribute to the development of accessible and cost-effective interventions that support symptom management and improve the daily functioning of postmenopausal women.
Trial Details
NCT Number NCT07302750
Lead Sponsor Baskent University
Conditions
(from sponsor)
Postmenopausal Period, Postmenopausal Women
Related terms Agnosia
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov