Children BehaviorPhase 4NCT02489812
Music Distraction Strategy in Children Dental Care
A Phase 4 study testing Music in people with Children Behavior, run by Federal University of Minas Gerais.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Behavior
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with syndromes
- Children without normal hearing
- Children thal not collaborated with the dentist
- Children with hospital and/or dental experience
About this study
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.
Read the 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.
- Conditions
- Children Behavior
- Being tested
- Music
- Keywords
- children, behavior, anxiety, dentistry
- Medical subject headings
- Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Also called The Mozart Symphony No 40 in G minor K550
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants
Children were selected through oral clinical exams, conducted in public schools.
Measured: 3 months
Secondary outcomes (1)
Composite measure of Cardiac and respiratory frequencies using a pulse oximeter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junia Maria Serra-Negra, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489812
- Sponsor's protocol ID
- UFMG
- Status last verified
- Jul 2015
- First submitted
- 26 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Distraction Strategy in Children Dental Care
- ClinicalTrials.gov ID
- NCT02489812
- Acronym / sponsor ID
- UFMG
- Conditions
- Children Behavior
- Keywords
- children, behavior, anxiety, dentistry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Behavioral: MusicThe 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Children with syndromes
- Children without normal hearing
- Children thal not collaborated with the dentist
- Children with hospital and/or dental experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicAlso: The Mozart Symphony No 40 in G minor K550This 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, | Behavioural | music |
Primary outcome
Number of participants
Time frame: 3 months
Children were selected through oral clinical exams, conducted in public schools.
1 secondary outcome
Composite measure of Cardiac and respiratory frequencies using a pulse oximeter
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Music in people with Children Behavior, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.