NCT02489812

Brief Summary

Music plays an important role reassuring helping reduce anxiety. Anxiety can be an interference factor in promoting oral health for children with high levels of anxiety tend to have negative behavior at the dentist. High oxygen levels and heart and respiratory frequencies are associated with high levels of anxiety. The objective of this study was to test the use of music in decreased cardiac and respiratory frequency of treated patients listening to music and being treated without hearing music.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

June 26, 2015

Last Update Submit

July 3, 2015

Conditions

Keywords

childrenbehavioranxietydentistry

Outcome Measures

Primary Outcomes (1)

  • Number of participants

    Children were selected through oral clinical exams, conducted in public schools.

    3 months

Secondary Outcomes (1)

  • Composite measure of Cardiac and respiratory frequencies using a pulse oximeter

    6 months

Study Arms (1)

music

EXPERIMENTAL

The Mozart Symphony No 40 in G minor K550 was played in headphones. While the child received restorative treatment in the teeth she heard music in a session and was subjected to other dental treatment session without listening to music. The cardiac and respiratory frequencies were measured with children's finger oximeter while the child listened to music and also in session in which she did not hear music. Changes in the measurements obtained by the oximeter showed levels of anxiety.

Behavioral: Music

Interventions

MusicBEHAVIORAL

This cross over trial aimed to analyze the use of music as a distraction resource during children dental treatment, evaluating their cardiac and respiratory frequency. Thirty-four children took part in this study, 16 boys and 18 girls, from 4 to 6 years old, with no previous dental experience, who had two carious lesions on occlusal surfaces of molars,

Also known as: The Mozart Symphony No 40 in G minor K550
music

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Without children experience provided at the dentist
  • Healthy children and without syndromes
  • Children with normal hearing
  • Children with two occlusal carious lesions with loss of enamel and dentin to 2/3 wherever possible to carry out the treatment technique Atraumatic Restorative adapted.

You may not qualify if:

  • Children with syndromes
  • Children without normal hearing
  • Children thal not collaborated with the dentist
  • Children with hospital and/or dental experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BehaviorAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 3, 2015

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07