Clinical trial NCT01643915: Behavior Management Using Audiovisual Tools
Official title: Behavior Management Using Audiovisual Tools in Pediatric Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Global Behavior During Previous Treatment Visits
Keywords: Audiovisual distraction
Pediatric dentistry
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 224
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Global behavior during the treatment
timeFrame: 14 days
Secondary outcomes:
measure: Parental perception of patients' anxiety
timeFrame: 14 days
measure: Self-reported anxiety during the treatment
timeFrame: 14 days
measure: Pain during the treatment
timeFrame: 14 days
measure: Heart rate during the treatment measures in different time points
timeFrame: 14 days
measure: Degree of acceptance of the distraction method by the pediatric patient
timeFrame: 14 days
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
citation: Ram D, Shapira J, Holan G, Magora F, Cohen S, Davidovich E. Audiovisual video eyeglass distraction during dental treatment in children. Quintessence Int. 2010 Sep;41(8):673-679.
citation: El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.