Music Distraction Strategy in Children Dental Care
1 other identifier
interventional
34
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2014
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedJuly 7, 2015
July 1, 2015
7 months
June 26, 2015
July 3, 2015
Conditions
Keywords
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
EXPERIMENTALThe 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.
Interventions
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,
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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