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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Intellectual and Developmental Differences, Dental Anxiety

Being tested

Live Music Therapy, Recorded Music

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Live Music TherapyBehavioural

  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.

• Recorded MusicBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Throughout the recruitment period

2. 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.

   Measured: Immediately after the dental procedure

3. 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.

   Measured: From initiation of physiological monitoring through completion of the dental procedure

4. 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.

   Measured: During administration of local anesthesia and throughout the dental procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Sep 2026
2. Study start30 Oct 2026 (estimated)
3. Primary completion1 Jun 2027 (estimated)
4. Study completion1 Jun 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Intellectual and Developmental DifferencesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.