Status:
COMPLETED
Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children
Lead Sponsor:
Plovdiv Medical University
Conditions:
Injection Pain
Local Anesthesia
Eligibility:
All Genders
8-12 years
Phase:
NA
Brief Summary
The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients. The clinical ...
Detailed Description
Achieving local anesthesia in children is one of the critical aspects of pain management. A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) d...
Eligibility Criteria
Inclusion
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
- Children without previous experience with local anesthesia for dental treatment.
- Obtained informed consent from parents or gave-givers to participate in the study.
Exclusion
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
- Vision requiring correction with eyeglasses.
- Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
- Children, who are first time ever dental patients.
Key Trial Info
Start Date :
December 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03772483
Start Date
December 15 2018
End Date
October 15 2019
Last Update
June 4 2021
Active Locations (1)
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1
Department of Pediatric Dentistry, Faculty of Dental Medicine
Plovdiv, Bulgaria, 4000