- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02489812
Music Distraction Strategy in Children Dental Care
Study Overview
Detailed Description
Feelings like anxiety can alter the levels of blood oxygenation from individuals in different situations, like during dental treatment. 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, from the 2 municipalities of southeast Brasil. Children were selected through oral clinical exams, conducted in public schools. After parents signed a written consent; children were allocated in two groups: treatment with music (G1) and treatment without music (G2). Children acted as controls of themselves: the cross between groups allowed all children to be treated with and without music. Three dental visits were, scheduled in a weekly basis, the first for anamnesis and clinical examination; the second and third for the modified atraumatic restorative treatment (ARTm). The Mozart Symphony No 40 in G minor K550 was played in headphones. Cardiac and respiratory frequencies were obtained using a pulse oximeter, with the measures being taken in three moments: in the beginning of the treatment, during the intervention (use of a rotating device) and at the end of the treatment. Data were compiled and analyzed through the statistic software Statistical Analyse. The Wilcoxon test was used for inter and intra groups comparison (p<0,050).
Music worked as a reassuring instrument during children dental treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Children with syndromes
- Children without normal hearing
- Children thal not collaborated with the dentist
- Children with hospital and/or dental experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music
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.
|
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,
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants
Time Frame: 3 months
|
Children were selected through oral clinical exams, conducted in public schools.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Composite measure of Cardiac and respiratory frequencies using a pulse oximeter
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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