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Not yet recruitingNCT07882979Updated Oct 20, 2026

Applying Comfort Theory to an AI-Assisted Group Music Intervention: Psychosocial and Physiological Outcomes and Feasibility in Long-Term Care Residents.

An interventional study of Group music intervention and AI-assisted monitoring system in Comfort Theory, AI-Assisted Group Music Intervention and Long-Term Care Residents, sponsored by Yu Chia Chang. Not yet recruiting at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Yu Chia Chang · Not applicable, Interventional, and Supportive care

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Yu Chia Chang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Stage 1: Group Music Intervention (AI Model Development)

    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.

    Behavioral: Group music intervention

  • Experimental
    Stage 2: AI-Assisted Group Music Intervention

    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.

    Behavioral: Group music intervention · Other: AI-assisted monitoring system

Interventions

  • BehavioralGroup music intervention

    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.

  • OtherAI-assisted monitoring system

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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)

  2. 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.

    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

  3. 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.

    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

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.

    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.

07

Study locations

1 site
  • China Medical University
    Taichung, Taiwan 406040, Taiwan
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.

Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 9 months is below that.

Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Oct 20, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jul 31, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882979
Lead sponsor
Yu Chia Chang
Responsible party
Yu Chia Chang (Assistant Professor, China Medical University Hospital) — Sponsor-investigator
First posted
Oct 20, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Yu-Chia Chang, PhD, RN.
Contact
iris827@mail.cmu.edu.tw
+886-4-22053366 ext. 7138

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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