Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Anxiety, Dental
• Intervention / Treatment: Behavioral: Music

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2019
• Primary Completion (ACTUAL): January 8, 2020
• Study Completion (ACTUAL): January 8, 2020

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (ACTUAL): May 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Dental Anxiety; Pediatric dentistry
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: HSC-DB-19-0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No