Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

Anxiety, Dental Clinical Trial

Official title:

Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03943836
• Other study ID #: HSC-DB-19-0220
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: March 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Dental

Intervention

Behavioral:
• Music
Patients in the music group will listen to classical music during their dental procedure.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety as assessed by the Pediatric 7 question survey	The total score ranges from 7-49, with lower scores indicating less anxiety.	baseline
Primary	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)
Primary	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