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Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Terminated
CT.gov ID
NCT03943836
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
12
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy
Actual Study Start Date :
Jul 9, 2019
Actual Primary Completion Date :
Jan 8, 2020
Actual Study Completion Date :
Jan 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Group

Patients listen to music

Behavioral: Music
Patients in the music group will listen to classical music during their dental procedure.
No Intervention: No Music group

Patients do not listen to music

Outcome Measures

Primary Outcome Measures

  1. Anxiety as assessed by the Pediatric 7 question survey [baseline]

    The total score ranges from 7-49, with lower scores indicating less anxiety.

  2. Anxiety as assessed by the Pediatric 7 question survey [immediately after the dental procedure (within 5 minutes after procedure)]

    The total score ranges from 7-49, with lower scores indicating less anxiety.

  3. Parent's prediction of child's anxiety in the dental office as assessed by survey [baseline]

    The total score ranges from 0-10. A lower score indicates less anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Nancy Ly, DDS, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brett Thomas Chiquet, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03943836
Other Study ID Numbers:
  • HSC-DB-19-0220
First Posted:
May 9, 2019
Last Update Posted:
Apr 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Brett Thomas Chiquet, Associate Professor, The University of Texas Health Science Center, Houston
Dental Anxiety
Pediatric dentistry
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Apr 11, 2022