Behavior Management Using Audiovisual Tools

Disruptive Global Behavior During Previous Treatment Visits Clinical Trial

Official title:

Behavior Management Using Audiovisual Tools in Pediatric Dental Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643915
• Other study ID #: UIC-ODP-2
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2021
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disruptive Global Behavior During Previous Treatment Visits

Intervention

Behavioral:
• No distraction method
Patients with conventional treatment. No distraction method during the treatment visits.
• 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.
• Distraction method
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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):673-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global behavior during the treatment		14 days
Secondary	Parental perception of patients' anxiety		14 days
Secondary	Self-reported anxiety during the treatment		14 days
Secondary	Pain during the treatment		14 days
Secondary	Heart rate during the treatment measures in different time points		14 days
Secondary	Degree of acceptance of the distraction method by the pediatric patient		14 days