Clinical trial NCT02929771: Using Virtual Reality to Reduce Procedural Pain in Children With Cancer
Official title: Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Virtual Reality
Subcutaneous Port Sampling
Pain
Children
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accural Rates/Retention Rates
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Outcome measure feasibility
timeFrame: 6 months
measure: Technical Difficulties/Practical Difficulties
timeFrame: 6 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 months
measure: Child Distress
timeFrame: 6 months
measure: Child Fear
timeFrame: 6 months
measure: Child Pain Catastrophizing
timeFrame: 6 months
measure: Parent Pain Catastrophizing
timeFrame: 6 months
measure: Parent Distress
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, RN, NP, PhD
role: PRINCIPAL_INVESTIGATOR
References: