Clinical trial NCT02489812: Music Distraction Strategy in Children Dental Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Children Behavior
Keywords: children
behavior
anxiety
dentistry
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants
timeFrame: 3 months
Secondary outcomes:
measure: Composite measure of Cardiac and respiratory frequencies using a pulse oximeter
timeFrame: 6 months
Other outcomes:
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