Using Virtual Reality to Reduce Procedural Pain in Children With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02929771|
Recruitment Status : Completed
First Posted : October 11, 2016
Last Update Posted : April 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Device: Samsung GearVR Device: iPad||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Intervention Group
In addition to usual care, the intervention group will receive the Samsung GearVR with head mounted display (HMD), controller, and headphones. They will situated in front of the nurse and beside/on the lap of the parent, or they may be lying supine. The VR intervention will use auditory and visual stimuli (simulating the peaceful underwater environment) to distract the child before, during, and after the SCP needle insertion. Children will be allowed to 'try-out' the VR system before the SCP access to familiarize themselves with the equipment. The entire study will be videotaped.
Device: Samsung GearVR
VR with head mounted display (HMD) and headphones. Treatment
Active Comparator: Control Group
In addition to usual care, participants in the control group will be seated with their parent and in front of the nurse, according to preference. Children will watch an age appropriate video selected by an oncology-affiliated child life specialist on an iPad, while wearing the same headphones used in the experimental condition. The RA will hold the iPad and positioned within a meter of the child so that the child can still see the iPad without the RA interfering in the clinical procedure. The entire study will be videotaped.
iPad with headphones. Control
- Accural Rates/Retention Rates [ Time Frame: 6 months ]Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.
- Acceptability [ Time Frame: 6 months ]Measured using the VR Distraction Satisfaction Questionnaire completed by children and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
- Outcome measure feasibility [ Time Frame: 6 months ]Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log
- Technical Difficulties/Practical Difficulties [ Time Frame: 6 months ]Record data related to technical/practical difficulties associated with the VR intervention, RA observed difficulties in implementing the trial protocol in the clinic and time to complete SCP access.
- Pain Intensity [ Time Frame: 6 months ]For both pre and post study procedures, children will self report their pain and parents, nurses and the RA will report children's pain using an 11 point NRS scale (0 being no pain at all and 10 being the most pain you can imagine this child or you having)
- Child Distress [ Time Frame: 6 months ]For both pre and post study procedures, distress during the SCP study will be measured using the observer-rated Behavioural Approach-Avoidance Scale (BAADS). 2 research team members will code video-recordings from all SCP needle insertion using the BAADS.
- Child Fear [ Time Frame: 6 months ]Children will report fear both prior to and following the procedure using the CFS which is a visual scale with established psychometrics in children as young as 5.
- Child Pain Catastrophizing [ Time Frame: 6 months ]Children will report baseline tendencies to catastrophize about pain using the PCS-C.
- Parent Pain Catastrophizing [ Time Frame: 6 months ]Parents will report baseline tendencies to catastrophize about their child's pain using the PCS-P which is a self-reporting measure of pain.
- Parent Distress [ Time Frame: 6 months ]Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929771
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jennifer Stinson, RN, NP, PhD||The Hospital for Sick Children|