Music Therapy During Dental Procedures in Adults With Intellectual and Developmental Disabilities
14. september 2026 oppdatert av: Adela Planerova, University of Rochester
Music Therapy to Improve Dental Procedure Tolerance and Reduce Distress in Adults With Intellectual and Developmental Differences
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dana Benoit, MBA
- Telefonnummer: 585-273-3797
- E-post: dana_benoit@urmc.rochester.edu
Studiesteder
-
-
New York
-
Rochester, New York, Forente stater, 14620
- Eastman Institute for Oral Health Complex Care Clinic
-
Ta kontakt med:
- Dana Benoit
- Telefonnummer: 585-273-3797
- E-post: dana_benoit@urmc.rochester.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adults (≥18 years) with a documented I/DD, including Autism Spectrum Disorder (ASD), Intellectual Disability, ADHD, or other DSM-5-defined neurodevelopmental conditions.
- Frankl Behavioral Rating Scale score of Negative (3) or Definitely Negative (4) at baseline assessment.
- English as primary language.
- Scheduled for non-emergency dental procedure with local anesthesia.
Exclusion Criteria:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Live Music Therapy
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.
|
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.
|
|
Aktiv komparator: Recorded Music
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Eligible Participants Who Consent to Participate
Tidsramme: 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.
|
Throughout the recruitment period
|
|
Mean Total Caregiver Acceptability Questionnaire Score After the Dental Procedure
Tidsramme: 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.
|
Immediately after the dental procedure
|
|
Percentage of Participants With Successful Physiological Monitoring During the Dental Procedure
Tidsramme: 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.
|
From initiation of physiological monitoring through completion of the dental procedure
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Frankl Behavioral Rating Scale Score During the Dental Procedure
Tidsramme: 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.
|
During the dental procedure
|
|
Mean Total Categorical Rating Scale Score During the Dental Procedure
Tidsramme: 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.
|
During administration of local anesthesia and throughout the dental procedure
|
|
Mean Heart Rate During the Dental Procedure
Tidsramme: Approximately every 10 minutes 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.
|
Approximately every 10 minutes during the dental procedure
|
|
Mean Peripheral Oxygen Saturation During the Dental Procedure
Tidsramme: Approximately every 10 minutes 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.
|
Approximately every 10 minutes during the dental procedure
|
|
Mean BioDot Skin Temperature During the Dental Procedure
Tidsramme: Approximately every 10 minutes 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.
|
Approximately every 10 minutes during the dental procedure
|
|
Percentage of Participants Who Complete the Planned Dental Procedure Without Escalation to Sedation
Tidsramme: During the dental procedure
|
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.
|
During the dental procedure
|
|
Mean Total Dental Procedure Duration
Tidsramme: During the dental procedure
|
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.
|
During the dental procedure
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Adela Planerova, University of Rochester
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
2. september 2026
Først innsendt som oppfylte QC-kriteriene
2. september 2026
Først lagt ut (Faktiske)
8. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00011628
- UM1TR005451 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .