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Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

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ClinicalTrials.gov Identifier: NCT03943836
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Nancy Ly, The University of Texas Health Science Center, Houston

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
Anxiety, Dental Behavioral: Music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Music Group Behavioral: Music
Patients in the music group will listen to classical music during their dental procedure.

No Intervention: No Music group



Primary Outcome Measures :
  1. Anxiety as assessed by the Pediatric 7 question survey (Venham scale) [ Time Frame: baseline ]
    The Venham scale is a visual analogue scale. The total score ranges from 7-49, with lower scores indicating less anxiety.

  2. Anxiety as assessed by the Pediatric 7 question survey (Venham scale) [ Time Frame: immediately after the dental procedure (within 5 minutes after procedure) ]
    The Venham scale is a visual analogue scale. The total score ranges from 7-49, with lower scores indicating less anxiety.

  3. Parent's prediction of child's behavior and anxiety in the dental office as assessed by a 2 question survey [ Time Frame: baseline ]
    The survey will assess both behavior and anxiety, with the total score ranging from 0-10. A lower score indicating less anxiety.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943836


Contacts
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Contact: Nancy Ly, DDS (713) 500-8220 Nancy.Ly@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Not yet recruiting
Houston, Texas, United States, 77030
Contact: Nancy Ly, DDS    713-500-8220    Nancy.Ly@uth.tmc.edu   
Contact: Brett Chiquet, DDS, PhD    (713) 500-8220    Brett.T.Chiquet@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Nancy Ly, DDS The University of Texas Health Science Center, Houston

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Responsible Party: Nancy Ly, Resident, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03943836     History of Changes
Other Study ID Numbers: HSC-DB-19-0220
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nancy Ly, The University of Texas Health Science Center, Houston:
Dental Anxiety
Pediatric dentistry

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders