AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorBaskent University

About this trial

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.

Eligibility criteria

Qualifiers

Women aged 45 to 65 years

Being in natural menopause (no menstrual bleeding for at least 12 months)

Having non-specific chronic musculoskeletal pain for at least 3 months (reporting a pain intensity of at least 4 cm on the VAS)

Using only standard analgesic medications for pain management

Disqualifiers

Surgical or medication-induced menopause

Regular use of opioid analgesics, anticonvulsants, antidepressants, or similar medications

Uncontrolled advanced cardiovascular, oncological, metabolic, rheumatologic, or neurological diseases

Body Mass Index (BMI) of 40 kg/m² or higher

Trial design

Treatments tested in this trial

  • Physiotherapist-Guided Relaxation and Breathing Training
  • Artificial Intelligence-Assisted Relaxation and Breathing Training
  • Control Group - No Structured Training Program

Treatment groups

48 Participants
are divided into 3 treatment groups

Sponsors and collaborators