Reducing Anxiety in Pediatric Dental Patients Through Pas... | NCT03943836

Studies
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

NCT03943836

Sponsor

The University of Texas Health Science Center, Houston

Status

Terminated

Last Update Posted

Apr 11, 2022Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Anxiety, Dental

Interventions

Music

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI, who was a Resident, graduated, and the project was not pursued further.

Expanded Access Info

Start Date

Jul 9, 2019Actual

Primary Completion Date

Jan 8, 2020Actual

Completion Date

Jan 8, 2020Actual

First Submitted Date

May 7, 2019

First Submission Date that Met QC Criteria

May 7, 2019

First Posted Date

May 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2022

Last Update Posted Date

Apr 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brett Thomas Chiquet, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Music Group	Experimental	Patients listen to music	Behavioral: Music
No Music group	No Intervention	Patients do not listen to music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music	Behavioral	Patients in the music group will listen to classical music during their dental procedure.	Music Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nancy Ly, DDS	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided