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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later May 1, 2027 → Jun 1, 2027
Primary endpoint added 3 → 4 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Start date pushed from Sep 30, 2026 to Oct 30, 2026
    • Primary and study completion pushed from May 1, 2027 to Jun 1, 2027
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 6
  2. Start date: Sep 30, 2026 to Oct 30, 2026
    • Primary and study completion dates: May 1, 2027 to Jun 1, 2027
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 5 words
  3. Re-verified, no change to tracked fields
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Rochester
191 trials monitored
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Anxiety
3,263 trials monitored
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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.
Trial Details
NCT Number NCT07806201
Lead Sponsor University of Rochester
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)		 Intellectual and Developmental Differences, Dental Anxiety
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov