AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

NCT07302750 | Not Yet Recruiting

• 1 other identifier: KA25/405
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postmenopausal; artificial intelligence; pain management; quality of life

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 ("no pain") to 10 ("unbearable pain").

  Baseline and Week 8

• Pressure Pain Threshold

  Pressure pain threshold will be measured using a digital algometer. Participants will indicate when they first perceive pain. Three measurements will be taken from each site, and the mean value will be used for analysis. All measurements will be completed by the same trained researcher.

  Baseline and Week 8

• Menopause-Specific Quality of Life

  The Menopause-Specific Quality of Life Questionnaire will be used to evaluate the impact of menopausal symptoms on quality of life. The scale consists of 32 items and four domains: vasomotor, psychosocial, physical, and sexual. Higher scores indicate higher symptom severity.

  Baseline and Week 8

Secondary Outcomes (4)

• Musculoskeletal Symptoms

  Baseline and Week 8

• Psychological Status

  Baseline and Week 8

• Dyspnea

  Baseline and Week 8

• Sleep Quality

  Baseline and Week 8

Other Outcomes (2)

• Participant Satisfaction

  Week 8

• Sociodemographic and Clinical Characteristics

  Baseline

Study Arms (3)

Physiotherapist-Guided Relaxation and Breathing Training

ACTIVE COMPARATOR

Participants will receive individual face-to-face relaxation and breathing training supervised by a physiotherapist.

Other: Physiotherapist-Guided Relaxation and Breathing Training

Artificial Intelligence-Assisted Relaxation and Breathing Training

EXPERIMENTAL

Participants will follow an AI-generated relaxation and breathing training program.

Other: Artificial Intelligence-Assisted Relaxation and Breathing Training

Control Group

SHAM COMPARATOR

Participants receive general information about relaxation and breathing exercises but do not participate in a structured program during the eight-week study period.

Other: Control Group - No Structured Training Program

Interventions

Artificial Intelligence-Assisted Relaxation and Breathing Training OTHER

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.

Artificial Intelligence-Assisted Relaxation and Breathing Training

Control Group - No Structured Training Program OTHER

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.

Control Group

Physiotherapist-Guided Relaxation and Breathing Training OTHER

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.

Physiotherapist-Guided Relaxation and Breathing Training

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Being literate
• Owning a smartphone or tablet, having the ability to listen to audio recordings, and having adequate skills to participate in online sessions
• Being willing to participate in the study and providing written informed consent

You may not qualify if:

• 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
• History of major surgery or severe trauma within the past 3 months

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Turkey (Türkiye)

Location

Related Publications (24)

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MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neslihan Durutürk, Prof. Dr.

  Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

• Aslıcan Çağlar, Asst. Prof.

  Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Şeyma Mutlu Kayaarslan, MSc.

  Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Hilal Yazici İlhan, MSc.

  Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neslihan Durutürk, Prof. Dr.

CONTACT

+90312 246 66 66; nalkan@baskent.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

TU (1)