Study Stopped
PI, who was a Resident, graduated, and the project was not pursued further.
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
1 other identifier
interventional
72
1 country
1
Brief Summary
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2020
CompletedApril 11, 2022
March 1, 2022
6 months
May 7, 2019
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
baseline
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
immediately after the dental procedure (within 5 minutes after procedure)
Parent's prediction of child's anxiety in the dental office as assessed by survey
The total score ranges from 0-10. A lower score indicates less anxiety.
baseline
Study Arms (2)
Music Group
EXPERIMENTALPatients listen to music
No Music group
NO INTERVENTIONPatients do not listen to music
Interventions
Patients in the music group will listen to classical music during their dental procedure.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II)
- Patient needs restorative procedure (with or without local anesthesia or nitrous oxide)
- Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons)
You may not qualify if:
- Patients with hearing impairments
- Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Ly, DDS
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
July 9, 2019
Primary Completion
January 8, 2020
Study Completion
January 8, 2020
Last Updated
April 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share