Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial

Pain Clinical Trial

Official title:

Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986464
• Other study ID #: 2017-1382
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: July 2019
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries.

This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.

Description:

BACKGROUND:

Preliminary data from the pilot study showed that the virtual reality prototype installed around the tank in the hydrotherapy room is a feasible and acceptable method of distraction that doesn't interfere with the work of healthcare professionals and could be used as a non-pharmacological method for pain management. A clinical trial is needed to assess the effectiveness of this intervention for procedural pain relief. The pilot study was also informative about the feasibility of the study design and the measurement used. The methods section was modified and adapted consequently for the upcoming trial.

METHODS:

Design: Within-subject/crossover study design. Each child will serve as their own control and will receive both standard and experimental treatment during the same hydrotherapy session through a randomized order.

Sample and Setting: Convenience sampling on the surgical-trauma burn unit at CHU Ste-Justine, of children admitted to the unit or to the day hospital for a burn injury. The intervention will take place in the hydrotherapy room of the CHU Ste-Justine.

Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR distraction through the use of a virtual reality prototype installed around the tank in the hydrotherapy room. The prototype has been developed in collaboration with the Society of Arts and Technology (SAT) in Montreal to provide an immersive interactive experience for the burn child in the hydrotherapy tank. The prototype was developed after several meetings between the researchers, the designers and engineers and the surgical trauma team of CHU Ste-Justine. Meetings were followed by an ergonomic study of the hydrotherapy room to meet the unit's and patients' specifications and ensure that it doesn't interfere with the healthcare professionals work.The video games were developed by our team with a personalized care content tailored to the children's developmental stage and to maximize the feeling of immersion and minimize cybersickness, and approved by a team of healthcare professionals in pediatric burn care.

Study proceedings: Hydrotherapy sessions typically last between 20 to 40 minutes. The duration will be divided into two sequences of the same duration (10 to 20 minutes) where the participant receives the same care by the same healthcare professional. For one sequence, only the standard treatment will be administered and for the other sequence, patients will receive the standard treatment in addition to Virtual Reality via the screen around the tank in a randomized order.

Measures: Pain and anxiety measures will be taken before the treatment session at Baseline (T1), in the middle of the first sequence of the session (T2) and in the middle of the second sequence of the session (T3) followed by a measure of healthcare professionals` satisfaction level via a questionnaire developed and pretested by the team after the session (T4). Data will be collected on the average doses of analgesics administered before and during the session, and the side effects experienced.

Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will be compared using Wilcoxon test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 7 Years

Eligibility

Inclusion Criteria:

• suffer from a burn injury requiring a hydrotherapy session

• presence of a consenting parent who can understand, read and write either French or English

Exclusion Criteria:

• Requiring intensive care

• Having a diagnosed cognitive impairment

• Are unconscious or intubated during the hydrotherapy sessions

• Suffering from epilepsy (considering the nature of the intervention)

• Allergic to opioids or other analgesics used for standard pharmacological treatment

• Having burn injuries on the face preventing them from looking at the VR screen

Will be excluded in posteriori from analysis children sedated for more than 50% of the time during one or both study sequences (score of 3 or 4 on the University of Michigan Sedation Scale).

Related Conditions & MeSH terms

• Burns
• Child
• Pain
• Pain, Procedural

Intervention

Device:
• Virtual Reality Prototype
VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.

Other:
• Standard Pharmacological Treatment
According to the unit's protocol and adjusted to each participant`s age, weight and condition by the anesthetist and the pain clinic nurse.

Locations

Country	Name	City	State
Canada	CHU Ste. Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Score	French version of the Face, Legs, Activity, Cry and Consolability (FLACC)	T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Secondary	Mean Pain Score - Observational/Behavioral Complementary measure	Visual Analog Scale by proxy	T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Secondary	Comfort	Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO)	T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Secondary	Sedation	University of Michigan Sedation Scale (UMSS)	T1: baseline; T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)
Secondary	Health professionals' satisfaction level	Pre-tested tailored questionnaire including tolerance, positive and negative aspects	T4: immediately after the procedure before leaving the hydrotherapy room
Secondary	Analgesic requirement	Rescue dose medication administration	T2: 5 minutes within the session (in the middle of the first sequence of the session); T3: 10 minutes within the session (in the middle of the second sequence of the session)