Trial Outcomes & Findings for Virtual Reality Distraction for Procedural Pain Management and Anxiety in Children With Burn Injuries : A Pilot Study (NCT NCT02794103)

Last Updated: 2019-09-26

Results Overview

To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR prototype during the hydrotherapy session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

T4, immediately after the procedure before leaving the hydrotherapy room

Results posted on

2019-09-26

Participant Flow

Data were collected at the pediatric burn unit of the CHU Sainte-Justine, in Montreal (Quebec, Canada) from June 14, 2016, to January 31, 2017.

Participants sedation levels were assessed after enrolment in the study and the patient was excluded if he/she was too sedated to participate in the experimental intervention.

Participant milestones

Participant milestones
Measure	Projector-based Virtual Reality Distraction Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Projector-based Virtual Reality Distraction Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Overall Study Loss to follow up due to high sedation	3

Baseline Characteristics

Virtual Reality Distraction for Procedural Pain Management and Anxiety in Children With Burn Injuries : A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Projector-based Virtual Reality Distraction n=15 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Age, Continuous	2.2 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Previous experience of procedural pain excluding vaccination Yes	5 Participants n=5 Participants
Previous experience of procedural pain excluding vaccination No	10 Participants n=5 Participants
Cause of burn injury Thermal	14 Participants n=5 Participants
Cause of burn injury Chemical	1 Participants n=5 Participants
Cause of burn injury Electrical	0 Participants n=5 Participants
Burn type Superficial (1st degree)	1 Participants n=5 Participants
Burn type Superficial partial-thickness (2nd degree)	2 Participants n=5 Participants
Burn type Deep partial-thickness (2nd degree)	8 Participants n=5 Participants
Burn type Full thickness (3rd-degree)	3 Participants n=5 Participants
Burn type 4th-degree	0 Participants n=5 Participants
Burn type missing data	1 Participants n=5 Participants
Extent of the burn (total body surface area- TBSA)	5 percentage of burned surface area STANDARD_DEVIATION 4 • n=5 Participants
Number of days since injury	4.5 days STANDARD_DEVIATION 3.7 • n=5 Participants
Number of hydrotherapy sessions before enrollment in the study None	11 Participants n=5 Participants
Number of hydrotherapy sessions before enrollment in the study 1 session	2 Participants n=5 Participants
Number of hydrotherapy sessions before enrollment in the study 2 sessions	1 Participants n=5 Participants
Number of hydrotherapy sessions before enrollment in the study 3 sessions	1 Participants n=5 Participants
Baseline anxiety Anxiety level 0 (least anxious, smiling, relaxed)	8 Participants n=5 Participants
Baseline anxiety Anxiety level 1 (tense)	5 Participants n=5 Participants
Baseline anxiety Anxiety level 2 (grumpy, apprehensive)	1 Participants n=5 Participants
Baseline anxiety Anxiety level 3 (most anxious, shouting)	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: T4, immediately after the procedure before leaving the hydrotherapy room

Population: Questionnaires for healthcare professionals present during the hydrotherapy session

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=81 questionnaires Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Acceptability Satisfaction with intervention	68.7 percentage of healthcare responses
Acceptability Allowed child to better cooperate with care	55.6 percentage of healthcare responses
Acceptability Intervention helped control pain	68.7 percentage of healthcare responses
Acceptability Intervention did not interfere with treatment/care	85.9 percentage of healthcare responses
Acceptability Prototype adapted to setting (hydrotherapy room)	91.3 percentage of healthcare responses
Acceptability Intervention adapted to age	90.2 percentage of healthcare responses
Acceptability Would use intervention in future procedures	100 percentage of healthcare responses

SECONDARY outcome

Timeframe: T1, 30 minutes before the procedure (patient's room); T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session

Population: Missing data due to high sedation levels before or after the procedure

Face, Legs, Activity, Cry and Consolability (FLACC)- Behavioral pain assessment scale for children from 0 to 18 years old that includes five separate items with each item scored on a range from 0 to 2 to provide a total score of pain from 0 to 10. Interpretation: 0= relaxed and comfortable, 1-3= Mild discomfort, 4-6= Moderate pain, and 7-10 = severe discomfort/pain.

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=15 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Pain Intensity T1	2.0 units on a scale from 0-10 Standard Deviation 2.4
Pain Intensity T2	2.1 units on a scale from 0-10 Standard Deviation 2.7
Pain Intensity T3	2.9 units on a scale from 0-10 Standard Deviation 3.0
Pain Intensity T4	2.6 units on a scale from 0-10 Standard Deviation 2.9
Pain Intensity T5	1.0 units on a scale from 0-10 Standard Deviation 1.7

SECONDARY outcome

Timeframe: T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session

Population: Missing data due to either high sedation level after the procedure or to the inability to verbalize anxiety which is required for measurement

Procedure Behaviour Check List (PBCL)- a behavioral scale that assesses anxiety based on 8 behaviors: muscular tension, screaming, crying, use of restraints, verbalization of pain, verbalization of anxiety, verbal stalling, and physical resistance. Each behavior is evaluated on a scale ranging from 1 (very slightly) to 5 (extremely intense) for a possible final score between 8 and 40, with a value of 8 meaning least anxious and 40 = most anxious.

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=7 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Anxiety Level T2	14.0 units on a scale from 8-40 Standard Deviation 9.4
Anxiety Level T3	11.7 units on a scale from 8-40 Standard Deviation 5.6
Anxiety Level T4	12.3 units on a scale from 8-40 Standard Deviation 6.0
Anxiety Level T5	8.0 units on a scale from 8-40 Standard Deviation 0.0

SECONDARY outcome

Timeframe: T3, during the procedure (10 min after the beginning of the hydrotherapy session)

Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO) - an observational scale that assesses comfort during hydrotherapy procedure with scores ranging from 0 to 10: 0 = most comfortable, 10 = least comfortable.

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=15 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Comfort Level	2.9 units on a scale from 0-10 Standard Deviation 2.8

SECONDARY outcome

Timeframe: T3, during the procedure (10 min after the beginning of the hydrotherapy session)

Number of Participants who needed additional (rescue dose) medication administration

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=15 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Number of Participants With Additional Analgesic Requirement	3 Participants

SECONDARY outcome

Timeframe: T2, before the procedure, upon arrival in the hydrotherapy room, T3, during the procedure (10 min after the beginning of the hydrotherapy session), T4, immediately after the procedure before leaving the hydrotherapy room

Ramsay sedation scale - ranging from 1 (anxious or restless or both) to 6 (no response to stimulus)

Outcome measures

Outcome measures
Measure	Projector-based Virtual Reality Distraction n=15 Participants Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Sedation Level T2	2 units on the RSS Interval 1.0 to 4.5
Sedation Level T3	2 units on the RSS Interval 1.0 to 3.5
Sedation Level T4	2 units on the RSS Interval 1.0 to 3.5

Adverse Events

Projector-based Virtual Reality Distraction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Projector-based Virtual Reality Distraction n=15 participants at risk Children received distraction in a virtual environment throughout the hydrotherapy session using a projector-based virtual reality dome environment. A video game (Bubbles®) developed for the purposes of the study was adapted to the prototype with a predefined speed of movement to avoid motion sickness.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • During and after the hydrotherapy procedure We didn't find any data in the literature stating that there were cases of Serious Adverse Events or Mortalities following the use of virtual reality in children. That is why we indicated that we didn't expect any cases.

Additional Information

Dr. Sylvie Le May, Professor & Researcher

Université de Montréal

Phone: 514 345-4931

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place