Music Therapy During Dental Procedures in Adults With Intellectual and Developmental Disabilities

Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Disabilities.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Anxiety; Intellectual and Developmental Disabilities
• Intervention / Treatment: Behavioral: Live Music Therapy; Behavioral: Recorded Music

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Benoit, MBA; Phone Number: 585-273-3797; Email: dana_benoit@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Eastman Institute for Oral Health Complex Care Clinic
      • Contact: Dana Benoit; Phone Number: 585-273-3797; Email: dana_benoit@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Live Music Therapy; Live music therapy will be delivered by a board certified music therapist before, during, and after the dental procedure as appropriate. Techniques may include live singing with guitar accompaniment, improvisation, music entrainment to breathing or heart rate, guided breathing synchronized with music, sung procedural cues, and participant engagement through instrument playing, singing, or vocal or instrumental improvisation. The intervention will be adapted in real time based on the participant's preferences, behavioral responses, physiological cues, and functional abilities.
Active Comparator: 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.	Behavioral: Recorded Music; Prerecorded music will be delivered through a portable Bluetooth speaker positioned within the dental operatory. Music will begin before administration of local anesthesia and continue throughout the procedure unless discontinued at the participant's request. Participants may select relaxation oriented music or a preferred available genre. Volume will be adjusted for participant comfort while maintaining communication with the dental team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eligible Participants Who Consent to Participate	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.	Throughout the recruitment period
Mean Total Caregiver Acceptability Questionnaire Score 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.	Immediately after the dental procedure
Percentage of Participants With Successful Physiological Monitoring During 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.	From initiation of physiological monitoring through completion of the dental procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Frankl Behavioral Rating Scale Score During the Dental Procedure	Behavioral cooperation is assessed using the Frankl Behavioral Rating Scale. Scores range from 1 to 4: 1 indicates Definitely Negative behavior, 2 indicates Negative behavior, 3 indicates Positive behavior, and 4 indicates Definitely Positive behavior. Higher scores indicate more positive behavior and greater cooperation during dental treatment. The outcome is the mean Frankl Behavioral Rating Scale score for each treatment group.	During the dental procedure
Mean Total Categorical Rating Scale Score During the Dental Procedure	Procedural behavior and distress are assessed using the Categorical Rating Scale, which includes four domains: crying, cooperation, apprehension, and sleep. Each domain is scored from 1 to 4. For crying, scores range from 1, screaming, to 4, no crying. For cooperation, scores range from 1, violently resisting or disrupting treatment, to 4, no movement. For apprehension, scores range from 1, hysterical and disobeying instructions, to 4, calm, relaxed, and following instructions. For sleep, scores range from 1, fully awake, to 4, sound asleep. Scores for the four domains are summed at each assessment to produce a total score ranging from 4 to 16. When multiple assessments are obtained during the procedure, total scores are averaged across assessment time points to generate one procedure level score for each participant. The outcome is the mean procedure level total score for each treatment group.	During administration of local anesthesia and throughout the dental procedure
Mean Heart Rate During the Dental Procedure	Heart rate is measured by pulse oximetry approximately every 10 minutes during the dental procedure and recorded in beats per minute. For each participant, heart rate measurements collected during the procedure are averaged to generate one mean procedural heart rate. The outcome is the mean participant level heart rate for each treatment group.	Approximately every 10 minutes during the dental procedure
Mean Peripheral Oxygen Saturation During the Dental Procedure	Peripheral oxygen saturation is measured by pulse oximetry approximately every 10 minutes during the dental procedure and recorded as percent oxygen saturation. For each participant, oxygen saturation measurements collected during the procedure are averaged to generate one mean procedural oxygen saturation value. The outcome is the mean participant level oxygen saturation for each treatment group.	Approximately every 10 minutes during the dental procedure
Mean BioDot Skin Temperature During the Dental Procedure	Peripheral skin temperature is assessed using a BioDot skin thermometer approximately every 10 minutes during the dental procedure. The BioDot changes color according to skin temperature. Manufacturer reference values include amber at approximately 89.6 degrees Fahrenheit, yellow at 90.6 degrees Fahrenheit, green at 91.6 degrees Fahrenheit, turquoise at 92.6 degrees Fahrenheit, blue at 93.6 degrees Fahrenheit, and violet at 94.6 degrees Fahrenheit. Black indicates a temperature outside the measurable color range. Quantifiable readings collected during the procedure are averaged for each participant. The outcome is the mean participant level skin temperature for each treatment group.	Approximately every 10 minutes during the dental procedure
Percentage of Participants Who Complete the Planned Dental Procedure Without Escalation to Sedation	Procedural completion is defined as completion of the planned dental procedure without escalation to pharmacological sedation. The outcome is calculated as the number of participants who complete the planned dental procedure without escalation to sedation divided by the total number of participants who undergo the study dental procedure, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate a greater rate of procedural completion without escalation to sedation.	During the dental procedure
Mean Total Dental Procedure Duration	Total dental procedure duration is recorded in minutes for each participant from the start of the planned dental procedure through procedure completion. The outcome is the mean total procedural duration in minutes for each treatment group.	During the dental procedure

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Adela Planerova, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: STUDY00000000; UM1TR005451 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No