Behavior Management Using Audiovisual Tools

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Completed

CT.gov ID

NCT01643915

Collaborator

(none)

224

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disruptive Global Behavior During Previous Treatment Visits	Behavioral: No distraction method Behavioral: Distraction method Behavioral: Distraction method	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

224 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Control group

Patients with conventional treatment. No distraction method during the treatment visits.

Behavioral: No distraction method

Patients with conventional treatment. No distraction method during the treatment visits.

Experimental: Experimental group 1

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

Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.

Experimental: Experimental group 2

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Behavioral: Distraction method

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Outcome Measures

Primary Outcome Measures

Global behavior during the treatment [14 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona	Spain	08195

Sponsors and Collaborators

Universitat Internacional de Catalunya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Francisco Guinot-Jimeno, DDS, MsC, Universitat Internacional de Catalunya

ClinicalTrials.gov Identifier:

NCT01643915

Other Study ID Numbers:

UIC-ODP-2

First Posted:

Jul 18, 2012

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Keywords provided by Francisco Guinot-Jimeno, DDS, MsC, Universitat Internacional de Catalunya

Audiovisual distraction

Pediatric dentistry

Study Results

No Results Posted as of May 10, 2021