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Набор по приглашению NCT07536360

The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study

Без фазы С лечением Loneliness Negative Affect Music Therapy Long-term Care Facility

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group Music Therapy.
Кому может быть актуально
Состояния в реестре: Loneliness, Negative Affect, Music Therapy, Long-term Care Facility. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Обзор

The goal of this pilot study is to learn whether group music therapy improves the emotional health of residents living in long-term care facilities. It will also examine the feasibility of integrating an artificial intelligence (AI)-based emotion recognition model into routine psychosocial interventions. The main questions it aims to answer are: Does group music therapy improve positive affect and reduce negative affect, depression, and loneliness among long-term care residents? Are AI-based facial emotion recognition results consistent with residents' self-reported emotional assessments? Researchers will use a one-group pretest-posttest quasi-experimental design to evaluate changes before and after a 6-week group music therapy program. The study will also compare subjective questionnaire results with objective facial emotion recognition outputs generated by the PaLI Gemma 2 multimodal model. Participants will: Attend one 60-minute group music therapy session per week for 6 weeks Complete emotional health questionnaires before the first session and after the sixth session Be recorded during sessions using a non-invasive camera system for facial emotion analysis Have their questionnaire results compared with AI-based emotion recognition outputs to evaluate consistency and feasibility This pilot study will provide preliminary evidence regarding both the psychological benefits of group music therapy and the feasibility of applying AI-supported multimodal emotion assessment in long-term care settings.

Подробное описание

Taiwan is entering a super-aged society, and an increasing number of older adults reside in long-term care (LTC) facilities. Although institutional care provides medical and daily living support, many residents experience loneliness, depressive symptoms, and reduced emotional well-being. Non-pharmacological interventions such as group music therapy have demonstrated beneficial effects on mood regulation, social interaction, and psychological health. However, most previous studies have relied primarily on self-report questionnaires or observer-rated scales, which may be influenced by cognitive status, expressive ability, or assessment bias.

This pilot study aims to evaluate both the psychological effects of group music therapy and the feasibility of integrating an artificial intelligence (AI)-based multimodal emotion recognition model into emotional assessment in LTC settings.

Study Design

This study uses a quasi-experimental one-group pretest-posttest design. Approximately 20 residents from a long-term care facility in central Taiwan will be recruited using convenience sampling.

Inclusion criteria include:

Age 65 years or older

Residency in the facility for at least 3 months

Possesses basic cognitive functions (0-2 errors on the SPMSQ scale)

Ability to participate in group activities

Provision of informed consent for participation and facial image collection

Residents with severe dementia, major psychiatric disorders, neurodegenerative diseases, severe sensory impairments, or recent participation in other psychological or music therapy programs will be excluded.

Intervention

Participants will receive a 6-week group music therapy program. Each participant will attend one 60-minute session per week, for a total of 6 sessions. Sessions will be conducted in small groups (approximately 10 participants per group) and led by a trained music therapist with support from nursing staff and research personnel.

Each session will include:

Music listening using culturally familiar songs

Instrument interaction (e.g., tambourines, hand bells, xylophones)

Singing and vocal expression activities

Short group sharing discussions to promote emotional expression and social connection

The intervention is designed to progressively enhance emotional engagement, social interaction, and psychological comfort in a supportive group environment.

Outcome Measures

Emotional health outcomes will be assessed at two time points:

T0 (baseline): Before the first session

T1 (post-intervention): Within 24 hours after the sixth session

Subjective measures include:

International Positive and Negative Affect Schedule Short Form (I-PANAS-SF)

Geriatric Depression Scale - 15 item version (GDS-15)

UCLA Loneliness Scale Version 3

Barthel Index (functional status, baseline only)

AI-Based Multimodal Emotion Analysis

During each music therapy session, participants' facial images will be captured using a non-invasive camera system under standardized environmental conditions.

The PaLI Gemma 2 multimodal model will analyze static facial images to generate:

Categorical emotion outputs (e.g., happy, sad, angry, fear, surprise, disgust, neutral)

Continuous emotion dimensions (valence and arousal values)

Emotion recognition outputs from Session 1 (baseline representation) and Session 6 (post-intervention representation) will be compared with corresponding subjective questionnaire scores. Correlation analyses (Pearson or Spearman) will examine the consistency and complementary value between AI-based emotion detection and self-reported emotional states.

Statistical Analysis

Descriptive statistics will summarize demographic and baseline characteristics.

Pre-post differences in emotional outcomes will be examined using:

Paired t-tests for normally distributed data

Wilcoxon signed-rank tests for non-normally distributed data

Effect sizes (Cohen's dz or r) and 95% confidence intervals will be reported to support future sample size estimation for larger trials.

Вмешательства

  • Другое Group Music Therapy
    This intervention consists of a structured 6-week group music therapy program designed for residents of a long-term care facility. Participants attend one 60-minute session per week, for a total of six sessions. Sessions are conducted in small groups (approximately 10 participants per group) and are led by a trained music therapist with support from nursing staff. The intervention follows an active music therapy approach and includes four core components: (1) listening to culturally familiar mu

Первичные конечные точки

  • Change in Positive Affect Score on the I-PANAS-SF [Срок оценки: Baseline, Week 6]
  • Change in Negative Affect Score on the I-PANAS-SF [Срок оценки: Baseline, Week 6]
Вторичные конечные точки (2)
  • Geriatric Depression Scale [Срок оценки: Baseline, Week 6]
  • UCLA Loneliness Scale [Срок оценки: Baseline and Week 6]

Критерии участия

Критерии включения

Aged 65 years or older

Resident of the long-term care facility for at least 3 months

SPMSQ scale error 0-2 questions

Medically stable and able to participate in group activities

Able to communicate and complete questionnaires (with assistance if needed)

Willing to provide written informed consent, including consent for facial image collection

Критерии исключения

Diagnosed with severe dementia

Diagnosed with major psychiatric disorders

Diagnosed with neurodegenerative diseases that significantly impair participation

Severe hearing or visual impairment that prevents engagement in music therapy activities

Participation in other psychological therapy or music therapy programs within the past 3 months

Acute medical condition requiring hospitalization or intensive treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Тайвань · 1 центр
  • China Medical University — Taichung

Публикации

  • Chang, Y.-C. (2026). The Effects of Group Music Therapy on the Emotional Health of Residents in Long-Term Care Facilities: A Pilot Study. Study protocol, China Medical University, Taichung, Taiwan. Unpublished.

Идентификаторы

NCT: NCT07536360 · CMU114-N-27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗