Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Differences
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Eligible Participants Who Consent to Participate
研究概览
简要总结
Adults with intellectual and developmental disabilities may experience behavioral distress, sensory sensitivity, and difficulty tolerating dental procedures. This pilot randomized controlled trial will compare live music therapy delivered by a board certified music therapist with recorded music during non emergency dental procedures performed under local anesthesia. Approximately 50 participants will be enrolled to obtain 40 evaluable participants randomized in a 1:1 ratio. The study will evaluate the feasibility and acceptability of live music therapy and its preliminary effects on behavioral cooperation, procedural distress, physiological responses, completion of dental treatment without escalation to sedation, and procedure duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with a documented I/DD, including Autism Spectrum Disorder (ASD), Intellectual Disability, ADHD, or other DSM-5-defined neurodevelopmental conditions.
- •Frankl Behavioral Rating Scale score of Negative (3) or Definitely Negative (4) at baseline assessment.
- •English as primary language.
- •Scheduled for non-emergency dental procedure with local anesthesia.
排除标准
- •Unwillingness to participate or refusal to provide informed consent
- •Legal inability to consent
- •Disinterest in or refusal of music therapy intervention
- •Scheduled for pharmacological sedation
研究组 & 干预措施
Live Music Therapy
Participants assigned to this arm will receive live music therapy delivered by a board certified music therapist during a scheduled non emergency dental procedure performed under local anesthesia. The intervention may include passive music listening, active music listening, guided breathing synchronized with music, sung procedural cues, live singing with guitar accompaniment, improvisation, tempo entrainment to breathing or heart rate, and participant directed instrument playing or singing. The intervention will be individualized according to participant preferences, responsiveness, and functional abilities. Sessions will be audio recorded to support intervention fidelity and characterization.
干预措施: Live Music Therapy (Behavioral)
Recorded Music
Participants assigned to this arm will receive prerecorded music through a portable Bluetooth speaker during a scheduled non emergency dental procedure performed under local anesthesia. Music will begin before administration of local anesthesia and continue throughout the dental procedure unless the participant requests discontinuation. Participants may select music from the study music library or select a preferred available genre. Music selection, duration of exposure, and interruptions will be documented.
干预措施: Recorded Music (Behavioral)
结局指标
主要结局
Percentage of Eligible Participants Who Consent to Participate
时间窗: Throughout the recruitment period
Recruitment feasibility is calculated as the number of eligible participants who provide informed consent divided by the total number of eligible participants approached for participation, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate greater recruitment feasibility.
Mean Total Caregiver Acceptability Questionnaire Score After the Dental Procedure
时间窗: Immediately after the dental procedure
Caregiver reported acceptability is assessed using a 10 item questionnaire administered after the dental procedure. Each item is scored from 1 to 5. Items 1 through 9 range from 1, Not at all, to 5, Very much. Item 10 ranges from 1, Definitely no, to 5, Definitely yes. The 10 item scores are summed to produce a total score ranging from 10 to 50. Higher total scores indicate greater caregiver reported acceptability and perceived benefit of the music intervention. The outcome is the mean total score across caregiver respondents.
Percentage of Participants With Successful Physiological Monitoring During the Dental Procedure
时间窗: From initiation of physiological monitoring through completion of the dental procedure
Physiological monitoring feasibility is calculated as the number of participants who successfully wear the required physiological monitoring device or devices as instructed throughout the dental procedure divided by the total number of participants undergoing physiological monitoring, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate greater feasibility of physiological monitoring.
次要结局
- Mean Frankl Behavioral Rating Scale Score During the Dental Procedure(During the dental procedure)
- Mean Total Categorical Rating Scale Score During the Dental Procedure(During administration of local anesthesia and throughout the dental procedure)
- Mean Heart Rate During the Dental Procedure(Approximately every 10 minutes during the dental procedure)
- Mean Peripheral Oxygen Saturation During the Dental Procedure(Approximately every 10 minutes during the dental procedure)
- Mean BioDot Skin Temperature During the Dental Procedure(Approximately every 10 minutes during the dental procedure)
- Percentage of Participants Who Complete the Planned Dental Procedure Without Escalation to Sedation(During the dental procedure)
- Mean Total Dental Procedure Duration(During the dental procedure)
研究者
Adela Planerova
Associate Professor of Clinical Dentistry
University of Rochester