Intellectual and Developmental DifferencesNCT07806201
Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Differences
A study testing Live Music Therapy and Recorded Music in people with Intellectual and Developmental Differences and Dental Anxiety, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual and Developmental Differences, Dental Anxiety
- What is being tested?
- Live Music Therapy and Recorded Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Eastman Institute for Oral Health Complex Care Clinic
Rochester, New York, 14620
Dana Benoit, 585-273-3797, dana_benoit@urmc.rochester.edu
About this study
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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Recorded Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
Secondary outcomes (6)
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.
Measured: During 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- 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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Adela Planerova, University of Rochester
- Investigators
- Adela Planerova, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806201
- Sponsor's protocol ID
- STUDY00011628
- Other IDs
- UM1TR005451
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Differences
- ClinicalTrials.gov ID
- NCT07806201
- Acronym / sponsor ID
- STUDY00011628
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Music Therapy | Experimental | Behavioral: 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. |
| Recorded Music | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Music TherapyLive 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. | Behavioural | Live Music Therapy |
| Recorded MusicPrerecorded 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. | Behavioural | Recorded Music |
Primary outcome
Percentage of Eligible Participants Who Consent to Participate
Time frame: Throughout the recruitment period
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.
Mean Total Caregiver Acceptability Questionnaire Score After the Dental Procedure
Time frame: Immediately 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.
Percentage of Participants With Successful Physiological Monitoring During the Dental Procedure
Time frame: From initiation of physiological monitoring through completion of 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.
Mean Total Categorical Rating Scale Score During the Dental Procedure
Time frame: During administration of local anesthesia and throughout 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.
6 secondary outcomes
Mean Frankl Behavioral Rating Scale Score During the Dental Procedure
Time frame: During the dental procedure
Mean Heart Rate During the Dental Procedure
Time frame: Approximately every 10 minutes during the dental procedure
Mean Peripheral Oxygen Saturation During the Dental Procedure
Time frame: Approximately every 10 minutes during the dental procedure
Mean BioDot Skin Temperature During the Dental Procedure
Time frame: Approximately every 10 minutes during the dental procedure
Percentage of Participants Who Complete the Planned Dental Procedure Without Escalation to Sedation
Time frame: During the dental procedure
Mean Total Dental Procedure Duration
Time frame: During the dental procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adela Planerova principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Music Therapy and Recorded Music in people with Intellectual and Developmental Differences and Dental Anxiety, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Benoit, MBA (585-273-3797, dana_benoit@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Participants Who Consent to Participate (time frame: Throughout the recruitment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.