Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890898
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-05-03
Brief Title:
Virtual Reality vs Nitrous Oxide in Pediatric Dentistry
Sponsor:
Geisinger Clinic
Organization:
Geisinger Clinic
Study Overview
Official Title:
Virtual Reality An Interventional Study Comparing the Use of Virtual Reality to Nitrous Oxide for Analgesia During Dental Procedures on Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study Control group will receive the standard of care dental treatment with under nitrous sedation N2O and will have a second visit where Virtual RealityVR goggles will be used instead of N2O The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit where N2O will be used instead of VR Procedures performed in all groups will be restorative treatments which can include intraoral anesthetic injections placing dental fillings crowns and the extractions of teeth In group 1 A specific VR headset the Oculus Quest 2 will be used Through the headset a video will be played for the child during a dental procedure
Detailed Description:
This is a prospective randomized controlled interventional therapy utilizing virtual reality goggles as a method of distraction Data will be collected during and after the procedure on the type of behavior displayed and the childs response to standardized questions Pediatric patients aged 4-12 years who only require nitrous sedation to complete painful dental treatment which necessitates anesthesia will be included in this study These patients exhibit Frankl 2-3 behavior requiring behavior guidance in order to complete the procedure Frankl 1 or 4 children those who do not need behavior guidance at all or children with heavy behavior guidance who would not be able to complete the procedure will be excluded
Participants will be recruited in the clinic during a new patient exam routine hygiene or operative dentistry appointment Following the Frankl behavior score diagnosis an evaluation of behavior will happen during the beginning of the appointment specifically watching for acceptance of treatment plan openness to conversation and any defiant behaviors or crying
The parent and child being recruited for the study will be informed of the nature of the study the possible risks benefit and alternatives and written consent will be obtained from the parent or legal guardian Assent from child 7 to 12 will also be required as well The qualifying patient will enter the operatory and be admitted into the study Participants will be briefed on how the study will proceed and will be randomized into a control group or treatment group The groups will be selected at random prior to treatment in the study Both Groups will use of Faces Legs Arms Crying ConsolabilityFLACC Scale WongBaker FACES and Houpt Behavior scales to access the pain or discomfort of subjects Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing Each face has a corresponding number 0 doesnt hurt at all to 10 hurts as much as you can imagine Patients will be observed during injection and assessed by the operator using the Faces Legs Arms Crying Consolability FLACC scale Each category will be rated from 0 to 2 Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to consolecomfort Patients will be observed during the procedure using the Houpt Behavioral Scale Each category is scored on the 0-2 scale which results in a total score of 0-10 Assessment of Behavioral Score 0 Relaxed and comfortable 1-3 Mild discomfort 4-6 Moderate pain 7-10 Severe discomfortpain
Patients receiving N2O during their visit will follow the standard of care procedures The VR goggles will be placed on the head and in front of the eyes Patients using the goggles are automatically set to start media as soon as the wearer dons them The patient will be reclined and placed in an ideal setting and the goggles will be calibrated to the patients current view The dental procedure will then follow Most procedures require a local anesthetic injection and if the patient receives this injection participants will be graded with FLACC score during the injection At the end of the procedure the child will be evaluated using the Wong-Baker FACES scale the Houpt Crying and Movement Scales and a survey will be given to the patient to be completed
Participants will participate in the study during two restorative dental appointments however some patients may need more than two visits Participants who require multiple restorative treatments will only being include in the study during first two visits and no other research activities will occur after Most appointments are projected to last a maximum of 1 hour The limiting factor in all treatment in this study will be the participants willingness to participate in future appointments
Participants will be recruited in the clinic during a new patient exam routine hygiene or operative dentistry appointment Following the Frankl behavior score diagnosis an evaluation of behavior will happen during the beginning of the appointment specifically watching for acceptance of treatment plan openness to conversation and any defiant behaviors or crying
The parent and child being recruited for the study will be informed of the nature of the study the possible risks benefit and alternatives and written consent will be obtained from the parent or legal guardian Assent from child 7 to 12 will also be required as well The qualifying patient will enter the operatory and be admitted into the study Participants will be briefed on how the study will proceed and will be randomized into a control group or treatment group The groups will be selected at random prior to treatment in the study Both Groups will use of Faces Legs Arms Crying ConsolabilityFLACC Scale WongBaker FACES and Houpt Behavior scales to access the pain or discomfort of subjects Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing Each face has a corresponding number 0 doesnt hurt at all to 10 hurts as much as you can imagine Patients will be observed during injection and assessed by the operator using the Faces Legs Arms Crying Consolability FLACC scale Each category will be rated from 0 to 2 Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to consolecomfort Patients will be observed during the procedure using the Houpt Behavioral Scale Each category is scored on the 0-2 scale which results in a total score of 0-10 Assessment of Behavioral Score 0 Relaxed and comfortable 1-3 Mild discomfort 4-6 Moderate pain 7-10 Severe discomfortpain
Patients receiving N2O during their visit will follow the standard of care procedures The VR goggles will be placed on the head and in front of the eyes Patients using the goggles are automatically set to start media as soon as the wearer dons them The patient will be reclined and placed in an ideal setting and the goggles will be calibrated to the patients current view The dental procedure will then follow Most procedures require a local anesthetic injection and if the patient receives this injection participants will be graded with FLACC score during the injection At the end of the procedure the child will be evaluated using the Wong-Baker FACES scale the Houpt Crying and Movement Scales and a survey will be given to the patient to be completed
Participants will participate in the study during two restorative dental appointments however some patients may need more than two visits Participants who require multiple restorative treatments will only being include in the study during first two visits and no other research activities will occur after Most appointments are projected to last a maximum of 1 hour The limiting factor in all treatment in this study will be the participants willingness to participate in future appointments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None