Music Therapy During Dental Procedures in Adults With Intellectual and Developmental Disabilities
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT07806201
- Status
- Not Yet Recruiting
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Conditions
- Dental Anxiety
- Intellectual and Developmental Disabilities
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Live Music Therapy — BEHAVIORALLive 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.
- Recorded Music — BEHAVIORALPrerecorded 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.
Study Details
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.
Key Dates
- First listed
- Sep 8, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- May 1, 2027
- Completion
- May 1, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Live Music TherapyParticipants 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.
- Active Comparator: Recorded MusicParticipants 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.
Primary Outcome Measure
Percentage of Eligible Participants Who Consent to Participate [ Time Frame: Throughout the recruitment period ]
Central Contacts
- Dana Benoit, MBA585-273-3797
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eastman Institute for Oral Health Complex Care Clinic | Rochester | New York | 14620 |
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