Comfort TheoryNCT07882979
Applying Comfort Theory to an AI-Assisted Group Music Intervention: Psychosocial and Physiological Outcomes and Feasibility in Long-Term Care Residents.
A study testing Group music intervention and AI-assisted monitoring system in people with Comfort Theory and AI-Assisted Group Music Intervention, run by Yu Chia Chang at 1 site in Taiwan.
Trial summary
The research design adopts a sequential two-phase framework. The study will be conducted in three residential LTC facilities located in Taichung City or Changhua County, with a total planned enrollment of 60 residents. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comfort Theory, AI-Assisted Group Music Intervention, Long-Term Care Residents
- What is being tested?
- Group music intervention and AI-assisted monitoring system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or older.
- Has lived in a participating residential long-term care facility for at least 3 months.
- Able to communicate in Mandarin or Taiwanese and follow simple instructions.
- Basic cognitive function, defined as 0 to 2 errors on the Short Portable Mental Status Questionnaire (SPMSQ).
- Stable vital signs with no current need for acute medical treatment.
- Fully informed and provides written informed consent personally.
Who cannot join
- Physician-diagnosed severe psychiatric disorder (such as schizophrenia or bipolar disorder) currently requiring long-term antipsychotic treatment.
- Acute illness or unstable health (such as acute infection or acute cardiovascular event) that makes participation in group activities unsuitable.
- Severe hearing or visual impairment that prevents effective participation in music activities or study assessments.
- Participation in other psychotherapy, psychological support programs, or music therapy-related research within the past 3 months.
- Judged unsuitable for participation by the research team together with facility professionals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The research design adopts a sequential two-phase framework. The study will be conducted in three residential LTC facilities located in Taichung City or Changhua County, with a total planned enrollment of 60 residents. In Phase 1, 20 residents from one facility will participate in a six-week group music intervention, with one session per week. This phase will focus on multimodal image data construction and AI model development. Facial expression data will be manually annotated to establish reference standards for emotion recognition, while upper-limb movements will be analyzed using pose estimation and skeletal recognition techniques to extract dynamic features. These data will be used to develop and preliminarily validate an AI-based emotion and activity response monitoring model.
In Phase 2, 40 residents who did not participate in Phase 1 will be recruited and divided into four groups to participate in a six-week group music intervention, with one session per week. The AI model developed in Phase 1 will be implemented in the LTC setting to transform residents' facial emotional expressions and upper-limb activity responses into low-interference visual information for the music therapist as an adjunct to activity facilitation and professional judgment. Evaluation indicators include subjective psychosocial measures of loneliness, anxiety, and depression, with heart rate variability (HRV) assessed in Phase 2 as an objective physiological measure.
This study expects to establish a multimodal dataset and an AI-based emotion and activity response monitoring model for group music activities in LTC settings and to preliminarily evaluate the feasibility of a human-AI collaborative approach characterized by "AI-assisted monitoring and human professional decision-making.
- Conditions
- Comfort Theory, AI-Assisted Group Music Intervention, Long-Term Care Residents, Loneliness, Anxiety, Depression
- Being tested
- Group music intervention, AI-assisted monitoring system
- Keywords
- Comfort Theory, AI-Assisted Group Music Intervention, Long-Term Care Residents, Loneliness, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group music interventionBehavioural
A standardized group music program led by a therapist with music therapy training: 6 sessions, once weekly for 6 weeks, about 60 minutes each, in groups of about 10 residents. Each session includes warm-up and body activation, core music interaction (rhythmic clapping, body movement, small percussion instruments, cooperative group activities), and music-guided relaxation with group feedback. Weekly themes progress from group building to rhythm synchronization, emotional expression, social connection, relaxation, and integration. Intensity is adjusted to residents' physical function and responses.
AI-assisted monitoring systemOther
A multimodal AI monitoring system developed in Stage 1 that analyzes video of residents' facial expressions (positive, neutral, negative) and upper-limb movement (pose estimation of shoulder, elbow, and wrist keypoints) during group music sessions. It shows simplified, low-interference visual trends for individual residents and the group to the music therapist. The system does not diagnose or make decisions; the therapist decides whether and how to adjust the activity based on AI cues, direct observation, and professional judgment.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Group Music Intervention (AI Model Development) | Experimental | The participants were divided into two groups of approximately 10 people each, based on the group activity schedule. To align with the institution's daily routine and research execution arrangements, the research team planned to conduct one group music activity each Wednesday morning and afternoon, with participation from both groups. Each resident received intervention once a week for six consecutive weeks, totaling six group music activities. The first phase of the activities primarily focused on multimodal image data collection, facial emotion annotation, upper limb skeletal movement feature extraction, and AI model development and preliminary validation. Receives: Behavioral: Group music intervention |
| Stage 2: AI-Assisted Group Music Intervention | Experimental | Forty residents from two other long-term care facilities who did not take part in Stage 1 (4 groups of about 10) receive the same 6-week group music program, led by a music therapist supported by real-time feedback from the AI monitoring system. Receives: Behavioral: Group music intervention; Other: AI-assisted monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale, Version 3
A 20-item self-report scale rated on a 4-point Likert scale (1 = never to 4 = always). Total scores range from 20 to 80, with higher scores indicating greater loneliness.
The score ranges are defined as follows: 20-34 points for low loneliness, 35-49 points for moderate loneliness, 50-64 points for high loneliness, and 65-80 points for severe loneliness.
Measured: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6)
Chinese version of Beck Anxiety Inventory
A 21-item scale with each item scored from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating more severe anxiety.
Measured: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 1 and 2 participants
Geriatric Depression Scale-15
A 15-item yes/no scale. Total scores range from 0 to 15, with higher scores indicating more depressive symptoms. Administered with the help of trained research staff.
Measured: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 1 and 2 participants
Secondary outcomes (1)
Heart Rate Variability
Resting HRV is recorded with an eSense HRV recorder (500 Hz sampling rate) during a 5-minute seated recording after 5 minutes of seated rest, under similar posture, time of day, and environment at both time points. Time-domain parameters (SDNN and RMSSD, ms) and frequency-domain parameters (LF and HF power, ms², and LF/HF ratio) are calculated from RR intervals.
Measured: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 2 participants only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comfort TheoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Chia Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Chia Chang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882979
- Sponsor's protocol ID
- NSTC 115-2314-B-039-023
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data include facial video recordings and health information of older adults living in long-term care facilities. To protect participant privacy and in accordance with the approved informed consent and ethics approval, individual participant data will not be shared. Results will be reported only in aggregate, de-identified form.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Comfort Theory to an AI-Assisted Group Music Intervention: Psychosocial and Physiological Outcomes and Feasibility in Long-Term Care Residents.
- ClinicalTrials.gov ID
- NCT07882979
- Acronym / sponsor ID
- NSTC 115-2314-B-039-023
- Conditions
- Comfort Theory, AI-Assisted Group Music Intervention, Long-Term Care Residents, Loneliness, Anxiety, Depression
- Keywords
- Comfort Theory, AI-Assisted Group Music Intervention, Long-Term Care Residents, Loneliness, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yu Chia ChangUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research design adopts a sequential two-phase framework. The study will be conducted in three residential LTC facilities located in Taichung City or Changhua County, with a total planned enrollment of 60 residents. In Phase 1, 20 residents from one facility will participate in a six-week group music intervention, with one session per week. This phase will focus on multimodal image data construction and AI model development. Facial expression data will be manually annotated to establish reference standards for emotion recognition, while upper-limb movements will be analyzed using pose estimation and skeletal recognition techniques to extract dynamic features. These data will be used to develop and preliminarily validate an AI-based emotion and activity response monitoring model.
In Phase 2, 40 residents who did not participate in Phase 1 will be recruited and divided into four groups to participate in a six-week group music intervention, with one session per week. The AI model developed in Phase 1 will be implemented in the LTC setting to transform residents' facial emotional expressions and upper-limb activity responses into low-interference visual information for the music therapist as an adjunct to activity facilitation and professional judgment. Evaluation indicators include subjective psychosocial measures of loneliness, anxiety, and depression, with heart rate variability (HRV) assessed in Phase 2 as an objective physiological measure.
This study expects to establish a multimodal dataset and an AI-based emotion and activity response monitoring model for group music activities in LTC settings and to preliminarily evaluate the feasibility of a human-AI collaborative approach characterized by "AI-assisted monitoring and human professional decision-making.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Group Music Intervention (AI Model Development) | Experimental | Behavioral: Group music interventionThe participants were divided into two groups of approximately 10 people each, based on the group activity schedule. To align with the institution's daily routine and research execution arrangements, the research team planned to conduct one group music activity each Wednesday morning and afternoon, with participation from both groups. Each resident received intervention once a week for six consecutive weeks, totaling six group music activities. The first phase of the activities primarily focused on multimodal image data collection, facial emotion annotation, upper limb skeletal movement feature extraction, and AI model development and preliminary validation. |
| Stage 2: AI-Assisted Group Music Intervention | Experimental | Behavioral: Group music intervention, Other: AI-assisted monitoring systemForty residents from two other long-term care facilities who did not take part in Stage 1 (4 groups of about 10) receive the same 6-week group music program, led by a music therapist supported by real-time feedback from the AI monitoring system. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 65 years or older.
- Has lived in a participating residential long-term care facility for at least 3 months.
- Able to communicate in Mandarin or Taiwanese and follow simple instructions.
- Basic cognitive function, defined as 0 to 2 errors on the Short Portable Mental Status Questionnaire (SPMSQ).
- Stable vital signs with no current need for acute medical treatment.
Key exclusion criteria (5 listed)
- Physician-diagnosed severe psychiatric disorder (such as schizophrenia or bipolar disorder) currently requiring long-term antipsychotic treatment.
- Acute illness or unstable health (such as acute infection or acute cardiovascular event) that makes participation in group activities unsuitable.
- Severe hearing or visual impairment that prevents effective participation in music activities or study assessments.
- Participation in other psychotherapy, psychological support programs, or music therapy-related research within the past 3 months.
- Judged unsuitable for participation by the research team together with facility professionals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group music interventionA standardized group music program led by a therapist with music therapy training: 6 sessions, once weekly for 6 weeks, about 60 minutes each, in groups of about 10 residents. Each session includes warm-up and body activation, core music interaction (rhythmic clapping, body movement, small percussion instruments, cooperative group activities), and music-guided relaxation with group feedback. Weekly themes progress from group building to rhythm synchronization, emotional expression, social connection, relaxation, and integration. Intensity is adjusted to residents' physical function and responses. | Behavioural | Stage 1: Group Music Intervention (AI Model Development), Stage 2: AI-Assisted Group Music Intervention |
| AI-assisted monitoring systemA multimodal AI monitoring system developed in Stage 1 that analyzes video of residents' facial expressions (positive, neutral, negative) and upper-limb movement (pose estimation of shoulder, elbow, and wrist keypoints) during group music sessions. It shows simplified, low-interference visual trends for individual residents and the group to the music therapist. The system does not diagnose or make decisions; the therapist decides whether and how to adjust the activity based on AI cues, direct observation, and professional judgment. | Other | Stage 2: AI-Assisted Group Music Intervention |
Primary outcome
UCLA Loneliness Scale, Version 3
Time frame: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6)
A 20-item self-report scale rated on a 4-point Likert scale (1 = never to 4 = always). Total scores range from 20 to 80, with higher scores indicating greater loneliness. The score ranges are defined as follows: 20-34 points for low loneliness, 35-49 points for moderate loneliness, 50-64 points for high loneliness, and 65-80 points for severe loneliness.
Chinese version of Beck Anxiety Inventory
Time frame: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 1 and 2 participants
A 21-item scale with each item scored from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating more severe anxiety.
Geriatric Depression Scale-15
Time frame: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 1 and 2 participants
A 15-item yes/no scale. Total scores range from 0 to 15, with higher scores indicating more depressive symptoms. Administered with the help of trained research staff.
1 secondary outcome
Heart Rate Variability
Time frame: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6) Measured in Stage 2 participants only.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data include facial video recordings and health information of older adults living in long-term care facilities. To protect participant privacy and in accordance with the approved informed consent and ethics approval, individual participant data will not be shared. Results will be reported only in aggregate, de-identified form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group music intervention and AI-assisted monitoring system in people with Comfort Theory and AI-Assisted Group Music Intervention, run by Yu Chia Chang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chia Chang, PhD, RN. (+886-4-22053366 ext. 7138, iris827@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale, Version 3 (time frame: T0 (pre-intervention): before the first group music session (week 1); T1 (post-intervention): after completion of the sixth group music session (week 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.