Dental Anxiety, Heart Rate and Rhythm Disorders, Infant Behavior, Pain
Conditions
Keywords
pain, infant behaviour, heart rate, dental anxiety
Brief summary
This will be a randomized, controlled, parallel-group clinical trial. The aim of this study will be to evaluate the effectiveness of Tell-Show-Do Behavior Management Technique versus a Conventional technique (covering the patient's vision) during an inferior alveolar and lingual nerve block in preschool children referred for treatment at the School of Dentistry, University of Sao Paulo, Brazil. The sample will consist of 52 children from 3 years old to 5 years 11 months old who need dental pulp treatment and / or tooth extraction of primary molars. Preschool children with no history of allergies to Lidocaine anesthetic or systemic/neurological diseases and who did not take local anesthesia before the study will be include in this research.
Detailed description
Children will be randomly allocated to treatment groups (n = 26 for each group) according to the technique: (1) Tell-Show-Do and (2) Conventional. Anxiety and pain will be evaluated by the scale of Facial Image (EIF) and Wong-Baker Pain Scale, respectively. The cooperation of the patient will be evaluated by behavioral scale Frankl.
Interventions
inferior alveolar and lingual nerve block
Sponsors
Evelyn Alvarez Vidigal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
36 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
1\. Preschool children with severe dental caries who need dental pulp treatment and / or tooth extraction of inferior primary molars.
Exclusion criteria
1. Preschool children with history of allergies to Lidocaine (local anesthetic) 2. Preschool children with systemic or neurological diseases 3. Preschool children who have received local dental anaesthesia before this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preschool children's anxiety levels changes before and after anesthesia procedure - Facial Image Scale (FIS) | Baseline and after one week | The children will be asked to point at which face they felt most like at that moment (row of five faces ranging from very happy to very unhappy - FIS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preschool children's pain levels - Wong-Baker FACES Pain Scale | At the end of the local anesthesia procedure (2 minutes) | The children were asked to point at which face they felt most like at that moment (row of six faces ranging from very happy-does not hurt to very unhappy-hurt as much as you can imagine) |
| Preschool children's behavior - Frankl Behavioral Rating Scale | Baseline and during the local anesthesia procedure (2 minutes) | It will be evaluated children's behavior (definitely negative, negative, definitely positive, positive) during de local anesthesia procedure |
| Heart rates | Baseline and during local anesthesia procedure | — |
| Parent's anxiety levels - Corah's dental anxiety scale (DAS) - parent questionnaire | Baseline | — |
| family socioeconomic indicators - questionnaire related to socioeconomic conditions | Baseline | questionnaire related to family socioeconomic conditions |
Countries
Brazil
Outcome results
None listed