Using Virtual Reality to Reduce Procedural Pain in Children With Cancer

Cancer Clinical Trial

Official title:

Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929771
• Other study ID #: 1000053757
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the impact of virtual reality (VR) in decreasing procedural pain related to subcutaneous port (SCP) access in children with cancer. The study is a pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with detailed information on the feasibility of implementing our trial protocol in a future multi-center RCT as well as preliminary estimate of VR treatment effect on children with cancer undergoing SCP access, including child and parent factors potentially associated with VR distraction treatment efficacy.

Description:

The study is a repeated-measures cross-over pilot RCT to examine the feasibility of the trial protocol for a study into the effectiveness of immersive VR in minimizing procedural pain and distress in children with cancer. The research objectives are to: (1) pilot implementing immersive virtual reality (VR) for effectiveness testing in a future RCT (measured as implementation outcomes); (2) determine treatment effect sizes (measured as preliminary effectiveness outcomes), between VR, programmed to distract children during an SCP needle insertion, and an active control intervention (i.e., watching a video with headphones); and (3) assess impact of child and parent factors potentially associated with VR treatment effectiveness. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 40 children and adolescents with cancer (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. In addition, each child will act as their own control. A washout period of 1 month will be used to control for any carry-over effect between conditions. In addition to usual care, children in the experimental condition will wear the VR headset plus headphones. In the control condition, children will watch a video (i.e., an age-appropriate video selected by an oncology-affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition. Implementation outcomes include accrual and retention rates, acceptability and technical difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Child and parent able to speak and understand English

• actively undergoing cancer treatment

• being less than 1 year from initial diagnosis

• requiring at least 2 SCP needle insertions for cancer treatment over the following 8 weeks

Exclusion Criteria:

• visual, auditory or cognitive impairments precluding interaction with the intervention or control equipment

• patients with major co-morbid medical or psychiatric conditions (including needle-phobia_ as per their healthcare provider or parent

• end of life patients

• patients with a MRSA infection or symptoms of respiratory or gastrointestinal infection as per any member of their healthcare team which could contaminate the intervention or control equipment

• participation in usability study

Related Conditions & MeSH terms

• Cancer
• Pain, Procedural

Intervention

Device:
• Samsung GearVR
VR with head mounted display (HMD) and headphones. Treatment
• iPad
iPad with headphones. Control

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accural Rates/Retention Rates	Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.	6 months
Primary	Acceptability	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.	6 months
Primary	Outcome measure feasibility	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	6 months
Primary	Technical Difficulties/Practical Difficulties	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.	6 months
Secondary	Pain Intensity	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)	6 months
Secondary	Child Distress	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.	6 months
Secondary	Child Fear	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.	6 months
Secondary	Child Pain Catastrophizing	Children will report baseline tendencies to catastrophize about pain using the PCS-C.	6 months
Secondary	Parent Pain Catastrophizing	Parents will report baseline tendencies to catastrophize about their child's pain using the PCS-P which is a self-reporting measure of pain.	6 months
Secondary	Parent Distress	Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.	6 months