MedDataX Logo

Trial Outcomes & Findings for Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents (NCT NCT01812655)

NCT ID: NCT01812655

Last Updated: 2013-08-06

Results Overview

The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Within the first 20 minutes following completion of the burn wound care procedure

Results posted on

2013-08-06

Participant Flow

Participants recruited from 6/2010 until 4/2012 in the outpatient Burn Center clinic.

One participant was re-assigned to standard care prior to group assignment when the virtual reality (VR) equipment failed during set-up.

Participant milestones

Participant milestones
Measure
Virtual Reality
Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
Passive Distraction
Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
SC Provided by the Nurses
Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
Overall Study
STARTED
9
11
10
Overall Study
COMPLETED
8
10
10
Overall Study
NOT COMPLETED
1
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Virtual Reality
Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
Passive Distraction
Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
SC Provided by the Nurses
Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
Overall Study
Protocol Violation
1
1
0

Baseline Characteristics

Comparison of Virtual Reality and Passive Distraction on Burn Wound Care Pain in Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Virtual Reality
n=9 Participants
Virtual reality using a software program designed for burn patients during burn wound care
Passive Distraction
n=11 Participants
watching a movie
Standard Care Provided by the Nurses
n=10 Participants
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
9 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
30 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age Continuous
14.3 years
STANDARD_DEVIATION 2.0 • n=5 Participants
12.6 years
STANDARD_DEVIATION 2.1 • n=7 Participants
13.9 years
STANDARD_DEVIATION 2.8 • n=5 Participants
13.5 years
STANDARD_DEVIATION 2.3 • n=4 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
9 Participants
n=4 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
9 Participants
n=7 Participants
8 Participants
n=5 Participants
21 Participants
n=4 Participants
Region of Enrollment
United States
9 participants
n=5 Participants
11 participants
n=7 Participants
10 participants
n=5 Participants
30 participants
n=4 Participants
STAIC - State Anxiety
34.4 Scores on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
27.0 Scores on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
33.6 Scores on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
31.5 Scores on a scale
STANDARD_DEVIATION 8.7 • n=4 Participants
STAIC - Trait Anxiety
34.6 Scores on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
33.5 Scores on a scale
STANDARD_DEVIATION 7.5 • n=7 Participants
34.1 Scores on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
34.0 Scores on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
Pre-Procedure Pain
40.1 Score on a scale
STANDARD_DEVIATION 30.9 • n=5 Participants
8.7 Score on a scale
STANDARD_DEVIATION 14.5 • n=7 Participants
22.9 Score on a scale
STANDARD_DEVIATION 26.0 • n=5 Participants
22.8 Score on a scale
STANDARD_DEVIATION 26.6 • n=4 Participants

PRIMARY outcome

Timeframe: Within the first 20 minutes following completion of the burn wound care procedure

Population: Intention to treat

The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).

Outcome measures

Outcome measures
Measure
Virtual Reality
n=8 Participants
Virtual reality using a software program designed for burn patients during burn wound care
Passive Distraction
n=10 Participants
watching a movie
Standard Care Provided by the Nurses
n=10 Participants
Self-reported Wound Care Procedure Pain Score
28.7 mm
Interval 14.1 to 43.3
52.4 mm
Interval 40.3 to 64.5
38.4 mm
Interval 27.4 to 49.4

SECONDARY outcome

Timeframe: Post-procedure (approximately 30-75 minutes)

Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire

Outcome measures

Outcome measures
Measure
Virtual Reality
n=8 Participants
Virtual reality using a software program designed for burn patients during burn wound care
Passive Distraction
n=10 Participants
watching a movie
Standard Care Provided by the Nurses
n=10 Participants
Desire for Distraction
Did not Answer Question
1 participants
1 participants
0 participants
Desire for Distraction
Yes
7 participants
7 participants
7 participants
Desire for Distraction
No
0 participants
2 participants
3 participants

SECONDARY outcome

Timeframe: Post-procedure (approximately 30-75 minutes)

For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: "Were you able to pay attention to the DVD or to the VR during your burn treatment?" (1=could not pay attention at all; 5=totally absorbed at all times) For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: "I believe that the distraction lessened my pain during my burn treatment today." (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)

Outcome measures

Outcome measures
Measure
Virtual Reality
n=8 Participants
Virtual reality using a software program designed for burn patients during burn wound care
Passive Distraction
n=10 Participants
watching a movie
Standard Care Provided by the Nurses
n=10 Participants
Engagement With Distraction and Belief in Distraction's Efficacy
Engagement with Distraction
3.6 scores on a scale
Standard Deviation 0.9
2.6 scores on a scale
Standard Deviation 1.1
NA scores on a scale
Standard Deviation NA
Participants were not asked because not applicable.
Engagement With Distraction and Belief in Distraction's Efficacy
Belief in Distraction's Efficacy
2.9 scores on a scale
Standard Deviation 1.2
2.6 scores on a scale
Standard Deviation 1.0
NA scores on a scale
Standard Deviation NA
Participants were not asked because not applicable.

Adverse Events

Virtual Reality

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Passive Distraction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

UC Provided by the Nurses

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debra Jeffs, PhD, RN, Principal Investigator

Arkansas Children's Hospital

Phone: 501-364-3239

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place