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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Physiotherapist-Guided Relaxation and Breathing Training
Other interventionParticipants 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.
Artificial Intelligence-Assisted Relaxation and Breathing Training
Other interventionIn 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.
Control Group - No Structured Training Program
Other interventionParticipants 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Physiotherapist-Guided Relaxation and Breathing TrainingActive comparator 1 intervention
Group B: Artificial Intelligence-Assisted Relaxation and Breathing TrainingExperimental treatment 1 intervention
Group C: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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").
Time frame
Baseline and Week 82
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.
Time frame
Baseline and Week 83
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. The minimum possible score is 1, and the maximum possible score is 8, with higher scores indicating worse outcomes. An increase in the total score reflects greater symptom severity and a decrease in quality of life.
Time frame
Baseline and Week 8Secondary outcomes
1
Musculoskeletal Symptoms
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.The questionnaire primarily provides categorical (yes/no) responses rather than a total scale score.
Time frame
Baseline and Week 82
Psychological Status
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 (0-3). Higher scores indicate greater severity of anxiety or depressive symptoms, representing worse outcomes.
Time frame
Baseline and Week 83
Dyspnea
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. The mMRC Dyspnea Scale is a 5-grade scale ranging from 0 to 4, with higher grades indicating greater breathlessness during daily activities. Higher scores indicate more severe dyspnea and a worse outcome.
Time frame
Baseline and Week 84
Sleep Quality
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.
Time frame
Baseline and Week 8Other outcomes
1
Participant Satisfaction
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."
Time frame
Week 82
Sociodemographic and Clinical Characteristics
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov