AI-Assisted Relaxation and Breathing Training in Postmenopausal Women

December 11, 2025 updated by: Neslihan Duruturk, Baskent University

The Effectiveness of Artificial Intelligence-Assisted Relaxation and Breathing Training on Pain Intensity and Quality of Life in Postmenopausal Women

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Menopause is a natural biological process defined by the 12 months following a woman's last menstrual cycle. It typically occurs between the ages of 40 and 50, with an average age of onset of around 51. The menopause process is divided into three main phases: perimenopause, menopause, and postmenopause. Perimenopause encompasses the few years preceding menopause, when menstrual cycles become irregular and vasomotor symptoms such as hot flashes and night sweats first appear. The menopausal period is defined as the absence of menstrual bleeding for 12 consecutive months, during which time typical menopausal symptoms become apparent. Postmenopause is the period that lasts for the remainder of a woman's life after menopause. During postmenopause, the decline in estrogen levels causes structural and functional changes in the musculoskeletal system, negatively affecting the integrity of bones, muscles, tendons, and ligaments. The risk of developing sarcopenia and osteoporosis increases during this period. Estrogen contributes to energy metabolism by regulating mitochondrial function in muscle cells; estrogen deficiency results in a decrease in mitochondrial numbers and impaired muscle metabolism. Furthermore, decreased estrogen can increase apoptosis in skeletal muscle, disrupt muscle protein balance, and negatively affect muscle strength. During this period, the prevalence of musculoskeletal pain increases with age, from premenopause to perimenopause and postmenopause. The prevalence of musculoskeletal pain in perimenopausal women has been reported to be approximately 71%; it has also been found that postmenopausal women have a significantly increased risk of experiencing moderate to severe pain compared to premenopausal women. In the literature, methods such as progressive muscle relaxation, breathing-focused awareness exercises and meditation-based relaxation techniques have been shown to reduce pain severity, reduce stress levels and improve quality of life in individuals experiencing chronic pain. These techniques facilitate control of pain perception by reducing muscle tension, improving breathing patterns, and balancing autonomic nervous system responses. For chronic musculoskeletal pain seen in menopausal and postmenopausal women, relaxation training stands out as an effective complementary physiotherapy-based method and significantly contributes to maintaining women's quality of life. Furthermore, chronic pain and menopausal symptoms are closely related to sleep disorders. Studies have shown that relaxation techniques and body-mind-based practices improve sleep quality. It has been reported that relaxation techniques can have positive effects not only on psychological well-being but also on musculoskeletal health. In particular, they have been reported to increase ease of movement and contribute to functional capacity by reducing muscle tension. While the effectiveness of traditional relaxation methods is well known, it is also thought that digital health technologies developed in recent years may offer new opportunities for physiotherapy practices. It has been reported that AI-based systems can be integrated into relaxation and mindfulness applications, providing personalized feedback to guide exercises and enabling sustainable practice in the home environment. Web-based interventions have been found effective in improving the health and quality of life of individuals across various diseases, health behaviors, and psychological conditions due to their advantages such as easy access, low cost, and anonymity. However, despite these strengths, the current status of AI-supported interventions, particularly those related to menopause, remains unclear. However, AI technologies hold the potential to provide personalized care, symptom prediction, and digital support in the management of menopausal symptoms. Furthermore, the effectiveness of AI-based relaxation training applications has not yet been demonstrated. There is a need for long-term, sustainable approaches to the management of chronic pain during menopause and postmenopause that will enhance the potential health benefits. In this context, our study aims to contribute to the literature and clinical practice by comparing the effectiveness of physiotherapist-assisted and AI-assisted relaxation training in postmenopausal women.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Baskent University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physiotherapist-Guided Relaxation and Breathing Training
Participants will receive individual face-to-face relaxation and breathing training supervised by a physiotherapist.
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.
Experimental: Artificial Intelligence-Assisted Relaxation and Breathing Training
Participants will follow an AI-generated relaxation and breathing training program.
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.
Sham Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline and Week 8
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
Time Frame: Baseline and Week 8
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
Time Frame: Baseline and Week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Musculoskeletal Symptoms
Time Frame: Baseline and Week 8
Musculoskeletal symptoms will be assessed using the Extended Nordic Musculoskeletal Questionnaire. This questionnaire evaluates pain, discomfort, and functional limitations in nine body regions (neck, shoulder, upper back, lower back, elbow, hand/wrist, hip, knee, ankle/foot) over the past 12 months. Additional items assess pain duration, severity, and impact on daily activities.
Baseline and Week 8
Psychological Status
Time Frame: Baseline and Week 8
The Hospital Anxiety and Depression Scale (HADS) will be used to assess the severity of anxiety and depression symptoms. The scale includes 14 items with two subscales-anxiety and depression-each scored using a 4-point Likert scale.
Baseline and Week 8
Dyspnea
Time Frame: Baseline and Week 8
Dyspnea severity will be evaluated using the Modified Medical Research Council (mMRC) Dyspnea Scale. Participants will indicate the level of physical activity that triggers shortness of breath.
Baseline and Week 8
Sleep Quality
Time Frame: Baseline and Week 8
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The scale evaluates sleep habits and sleep-related problems over the past month. Component scores range from 0 to 3, producing a total score between 0 and 21. Scores of 5 or higher indicate poor sleep quality.
Baseline and Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction
Time Frame: Week 8
Satisfaction with the relaxation and breathing training program will be measured using a 10 cm Visual Analog Scale (VAS), where 0 cm indicates "not satisfied at all" and 10 cm indicates "completely satisfied."
Week 8
Sociodemographic and Clinical Characteristics
Time Frame: Baseline

Participants' sociodemographic and clinical characteristics will be recorded using a personal information form. The form will include name, age, height, weight, body mass index, education level, marital status, employment status, and exercise habits. In addition to medical history, menopausal age and menopausal type will be determined based on participants' self-reports.

Data collected before and after the training will be obtained from participant self-reports and medical records. Participants' ability to use a smartphone, listen to audio recordings, and participate in online sessions will also be assessed through self-report.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Study Director: Neslihan Durutürk, Prof. Dr., Başkent University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA25/405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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