AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

NCT07302750 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-24

No results posted yet for this study

Summary

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.

Conditions

  • Postmenopausal Period
  • Postmenopausal Women

Interventions

OTHER

Physiotherapist-Guided Relaxation and Breathing Training

Participants will perform the sessions individually and face-to-face under the supervision of a physiotherapist. Relaxation positions and breathing exercises will be guided and monitored by the physiotherapist. The training will be conducted three days a week for eight weeks, with each session lasting approximately 30 minutes.

OTHER

Artificial Intelligence-Assisted Relaxation and Breathing Training

In this group, a 30-minute relaxation and breathing training script will be created by the researchers based on instructional prompts provided to the artificial intelligence system. The generated script will be reviewed and finalized by the researchers and then converted into an audio file using an AI-based voice generation program. Participants will listen to these audio recordings asynchronously via smartphone or tablet, three days a week for eight weeks, with each session lasting approximately 30 minutes. They will also be asked to keep a daily practice log.

OTHER

Control Group - No Structured Training Program

Participants will be informed about relaxation and breathing exercises. After the initial assessments, they will be asked to continue their daily routines and not to participate in any structured exercise training program for eight weeks. After the intervention period, participants in the control group will be invited to join one of the training groups if they wish.

Sponsors & Collaborators

  • Baskent University

    lead OTHER

Principal Investigators

  • Neslihan Durutürk, Prof. Dr. · Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  • Aslıcan Çağlar, Asst. Prof. · Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  • Şeyma Mutlu Kayaarslan, MSc. · Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  • Hilal Yazici İlhan, MSc. · Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302750 on ClinicalTrials.gov