Clinical trial NCT03435367: Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department
Official title: Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IV Insertion in the Emergency Department
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 58
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department. Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting. In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion. The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction. If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.

Detailed description: This study is a pilot randomized control trial that aims to (a) to determine the differences in self-reported and proxy-reported pain and fear during IV insertion between the interactive VR intervention and control group, and (b) to assess the feasibility (safety, acceptability) of the VR intervention to children/families and the healthcare team in the pediatric emergency department. The study will consist of two study arms, where both study arms will be screened and recruited using the same procedure. Participants will be randomized into either (1) Control group: child life specialist plays an age-appropriate video on a tablet device, or (2) Intervention (VR Distraction): child life specialist facilitates immersive VR experience. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 80 children and adolescents with cancer (40 participants per treatment arm; 20 boys and 20 girls per treatment arm) will be recruited. 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 emergency department 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 will be:

1. aged 8-17 years
2. able to speak and understand English
3. parent/guardian present
4. medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
5. requires IV insertion

Exclusion criteria will be:

1. visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
2. psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
3. skin, face or ear infections or injuries, which could contaminate the intervention equipment
4. medically unstable (CTAS 1; patient requires immediate IV insertion)

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline, 30 minutes after baseline
measure: Change in Child Distress
timeFrame: Baseline, 30 minutes after baseline
measure: Change in Child Fear
timeFrame: Baseline, 30 minutes after baseline
measure: Child Pain Catastrophizing
timeFrame: Baseline
measure: Parent Pain Catastrophizing
timeFrame: Baseline
measure: Parent Distress
timeFrame: 30 minutes after baseline measures are completed
measure: Child Presence Measure
timeFrame: 30 minutes after baseline measures are completed
Secondary outcomes:
measure: Recruitment log
timeFrame: through study completion, an average of 1 year
measure: Acceptability
timeFrame: 30 minutes after baseline measures are completed
measure: Outcome measure feasibility
timeFrame: through study completion, an average of 1 year
measure: Technical Difficulties Log
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References: