Effect of PlayStation Distraction in the Dental Setting

Global Behaviour Measure Clinical Trial

Official title:

Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180386
• Other study ID #: UIC-ODP-3
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2016

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 dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.

Description:

global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• Patients aged 6-8 years.

• Patients who required a minimum of 2 visits for restorative treatment.

Exclusion Criteria:

• Patients with reduced audiovisual capabilities.

• Patients with psychological disorders.

Related Conditions & MeSH terms

• Global Behaviour Measure

Intervention

Behavioral:
• Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
videogame can be considered as a method of distraction.

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Sant Cugat del Valles	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	we will use the Frankl Scale	14 days
Secondary	Parental perception of patient's anxiety	we will use the Modified Corah Anxiety Scale Questionnaire	14 days
Secondary	Self-reported anxiety during the treatment	we will use the Venham Picture Test	14 days
Secondary	Dental pain during the treatment	We will use the Wong-Baker Faces Scale	14 days
Secondary	Heart rate during the treatment measures in different time points	We will use the the pulse oximeter	14 days
Secondary	Degree of acceptance of the distraction method by the pediatric patient	"Did you enjoy seeing the cartoon film during the dental visit?" (Yes/No)	14 days