Behavior Management Using Audiovisual Tools

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

Detailed Description
-----------------
Each patient required a minimum of 2 visits for restorative treatment in a mandibular quadrant and had undergone a previous restorative dental experience. All parents or guardians of the children who participated in the study were informed about the study before enrolment, and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were not present in the operating room during the treatment. The maximum time between the 2 treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the standard process of a paediatric dental visit, the child was given an explanation as to what the visit would comprise, with the aim of interrupting the treatment as little as possible. The children knew at the beginning of the first appointment (control) that they would be able to watch a movie or play a videogame during their next visit.

Official Title
-----------------
Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Conditions
-----------------
Disruptive Global Behavior During Previous Treatment Visits

Intervention / Treatment
-----------------
* Behavioral: No distraction method
* Behavioral: Distraction method
* Behavioral: Distraction method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 4-9 years. Patients who required a minimum of 2 visits for restorative treatment. Patients who had previously shown disruptive behavior (Frankl Behavior Rating Scale 1 or 2) during dental restorative treatment or pulp therapy. Exclusion Criteria: Patients with reduced audiovisual capabilities. Patients with psychological disorders.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients with conventional treatment. No distraction method during the treatment visits. | Behavioral: No distraction method<br>* Patients with conventional treatment. No distraction method during the treatment visits.<br>|
| Experimental: Experimental group 1<br>Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit. | Behavioral: Distraction method<br>* Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.<br>|
| Experimental: Experimental group 2<br>Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. | Behavioral: Distraction method<br>* Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global behavior during the treatment |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental perception of patients' anxiety |  | 14 days | 
| Self-reported anxiety during the treatment |  | 14 days | 
| Pain during the treatment |  | 14 days | 
| Heart rate during the treatment measures in different time points |  | 14 days | 
| Degree of acceptance of the distraction method by the pediatric patient |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Audiovisual distraction, Pediatric dentistry