Back to resultsReducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
Primary Purpose
Anxiety, Dental
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional other trial for Anxiety, Dental focused on measuring Dental Anxiety, Pediatric dentistry
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients with hearing impairments
- Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music Group
No Music group
Arm Description
Patients listen to music
Patients do not listen to music
Outcomes
Primary Outcome Measures
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
Anxiety as assessed by the Pediatric 7 question survey
The total score ranges from 7-49, with lower scores indicating less anxiety.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03943836
First Posted
May 7, 2019
Last Updated
March 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03943836
Brief Title
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
Official Title
Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
PI, who was a Resident, graduated, and the project was not pursued further.
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Dental
Keywords
Dental Anxiety, Pediatric dentistry
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Group
Arm Type
Experimental
Arm Description
Patients listen to music
Arm Title
No Music group
Arm Type
No Intervention
Arm Description
Patients do not listen to music
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Patients in the music group will listen to classical music during their dental procedure.
Primary Outcome Measure Information:
Title
Anxiety as assessed by the Pediatric 7 question survey
Description
The total score ranges from 7-49, with lower scores indicating less anxiety.
Time Frame
baseline
Title
Anxiety as assessed by the Pediatric 7 question survey
Description
The total score ranges from 7-49, with lower scores indicating less anxiety.
Time Frame
immediately after the dental procedure (within 5 minutes after procedure)
Title
Parent's prediction of child's anxiety in the dental office as assessed by survey
Description
The total score ranges from 0-10. A lower score indicates less anxiety.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Patients with hearing impairments
Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Ly, DDS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy
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