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

NCT07806201 | Not Yet Recruiting

• 2 other identifiers: STUDY00011628UM1TR005451
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with intellectual and developmental differences 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.

Conditions

Intellectual and Developmental Differences; Dental Anxiety

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (6)

• Mean Frankl Behavioral Rating Scale Score During the Dental Procedure

  During 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

Study Arms (2)

Live Music Therapy

EXPERIMENTAL

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

Recorded Music

ACTIVE COMPARATOR

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

Interventions

Live Music Therapy BEHAVIORAL

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.

Live Music Therapy

Recorded Music BEHAVIORAL

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.

Recorded Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) with a documented I/DD, including Autism Spectrum Disorder (ASD), Intellectual Functional Limitation, ADHD, or other DSM-5-defined neurodevelopmental conditions.
• Frankl Behavioral Rating Scale score of Negative (2) or Definitely Negative (1) at baseline assessment.
• English as primary language.
• Scheduled for non-emergency dental procedure with local anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Eastman Institute for Oral Health Complex Care Clinic

Rochester, New York, 14620, United States

Location

Study Officials

• Adela Planerova

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Benoit, MBA

CONTACT

585-273-3797; dana_benoit@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Dentistry

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (1)