Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195, Spain
Completed
NCT Number: NCT01643915
Behavior Management Using Audiovisual Tools
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.
Completed
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Notify MeKey information
Age range
4 year–9 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
No distraction method
BehavioralPatients with conventional treatment. No distraction method during the treatment visits.
Distraction method
BehavioralPatients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
Primary outcomes
-
Global behavior during the treatment
Time frame: 14 days
Secondary outcomes
-
Parental perception of patients' anxiety
Time frame: 14 days
-
Self-reported anxiety during the treatment
Time frame: 14 days
-
Pain during the treatment
Time frame: 14 days
-
Heart rate during the treatment measures in different time points
Time frame: 14 days
-
Degree of acceptance of the distraction method by the pediatric patient
Time frame: 14 days
Sponsors and collaborators
Lead sponsor
Universitat Internacional de Catalunya
Other
Registry information
Official study title
Behavior Management Using Audiovisual Tools in Pediatric Dental Patients
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 18, 2012
- Registry last updated
- May 10, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.