Burns, Pain, Wound Care
Conditions
Keywords
pain, anxiety, children, adolescents, burn, virtual reality, distraction
Brief summary
Relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. Little is known about distraction's effectiveness. Virtual reality may be an effective distraction. The aims of this study are 1)to evaluate the effect of virtual reality (VR), a newer interactive kind of distraction, compared to passive distraction (PD) by watching a movie, and usual care (SC) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.
Interventions
DEVICEVirtual Reality
OTHERPassive Distraction
Sponsors
Arkansas Children's Hospital Research Institute
Arkansas Biosciences Institute
Arkansas Children's Hospital Burn Center
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* undergoing burn wound care in the Arkansas Children's Hospital (ACH) outpatient burn clinic; * first time visit to the ACH outpatient burn clinic or first clinic visit without conscious sedation; * adolescents ages 10 to 17 years; * English speaking; * absence of a history of motion sickness (motion sickness has been reported in some VR users); * absence of a seizure disorder (because prolonged immersion in VR may lead to seizures and vertigo in individuals with seizure disorders, these individuals will be excluded from the study); * absence of a cognitive developmental disability determined on prescreening by presence of a Section 504 accommodation plan or Title VIII individualized educational plan (IEP) in school. If the parent identifies the nature of the IEP or 504 plan as unrelated to a cognitive delay, then the child or adolescent will be included in the study.
Exclusion criteria
* Burns that would interfere with study procedures * Incarcerated minors * Children in foster care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Wound Care Procedure Pain Score | Within the first 20 minutes following completion of the burn wound care procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Desire for Distraction | 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 |
| Engagement With Distraction and Belief in Distraction's Efficacy | 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) |
Countries
United States
Participant flow
Recruitment details
Participants recruited from 6/2010 until 4/2012 in the outpatient Burn Center clinic.
Pre-assignment details
One participant was re-assigned to standard care prior to group assignment when the virtual reality (VR) equipment failed during set-up.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality Virtual reality using a software program designed for burn patients during burn wound care | 9 |
| Passive Distraction watching a movie | 11 |
| Standard Care Provided by the Nurses | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Virtual Reality | Passive Distraction | Standard Care Provided by the Nurses | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 11 Participants | 10 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 14.3 years STANDARD_DEVIATION 2 | 12.6 years STANDARD_DEVIATION 2.1 | 13.9 years STANDARD_DEVIATION 2.8 | 13.5 years STANDARD_DEVIATION 2.3 |
| Pre-Procedure Pain | 40.1 Score on a scale STANDARD_DEVIATION 30.9 | 8.7 Score on a scale STANDARD_DEVIATION 14.5 | 22.9 Score on a scale STANDARD_DEVIATION 26 | 22.8 Score on a scale STANDARD_DEVIATION 26.6 |
| Region of Enrollment United States | 9 participants | 11 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 8 Participants | 21 Participants |
| STAIC - State Anxiety | 34.4 Scores on a scale STANDARD_DEVIATION 9.1 | 27.0 Scores on a scale STANDARD_DEVIATION 4 | 33.6 Scores on a scale STANDARD_DEVIATION 10.6 | 31.5 Scores on a scale STANDARD_DEVIATION 8.7 |
| STAIC - Trait Anxiety | 34.6 Scores on a scale STANDARD_DEVIATION 5 | 33.5 Scores on a scale STANDARD_DEVIATION 7.5 | 34.1 Scores on a scale STANDARD_DEVIATION 7.1 | 34.0 Scores on a scale STANDARD_DEVIATION 6.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Self-reported Wound Care Procedure Pain Score
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).
Time frame: Within the first 20 minutes following completion of the burn wound care procedure
Population: Intention to treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Virtual Reality | Self-reported Wound Care Procedure Pain Score | 28.7 mm |
| Passive Distraction | Self-reported Wound Care Procedure Pain Score | 52.4 mm |
| Standard Care Provided by the Nurses | Self-reported Wound Care Procedure Pain Score | 38.4 mm |
p-value: 0.02995% CI: [2.4, 45]Regression, Linear
p-value: 0.3295% CI: [-9.5, 28.9]Regression, Linear
Secondary
Desire for Distraction
Participants were asked I wanted to be distracted from during my treatment today. (Agree-Disagree) from the Post-Procedure Questionnaire
Time frame: Post-procedure (approximately 30-75 minutes)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Virtual Reality | Desire for Distraction | Did not Answer Question | 1 participants |
| Virtual Reality | Desire for Distraction | Yes | 7 participants |
| Virtual Reality | Desire for Distraction | No | 0 participants |
| Passive Distraction | Desire for Distraction | Did not Answer Question | 1 participants |
| Passive Distraction | Desire for Distraction | Yes | 7 participants |
| Passive Distraction | Desire for Distraction | No | 2 participants |
| Standard Care Provided by the Nurses | Desire for Distraction | Did not Answer Question | 0 participants |
| Standard Care Provided by the Nurses | Desire for Distraction | Yes | 7 participants |
| Standard Care Provided by the Nurses | Desire for Distraction | No | 3 participants |
p-value: 0.26Semipartial correlation
p-value: 0.59Semipartial correlation
p-value: 0.6Semipartial correlation
Secondary
Engagement With Distraction and Belief in Distraction's Efficacy
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)
Time frame: Post-procedure (approximately 30-75 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality | Engagement With Distraction and Belief in Distraction's Efficacy | Engagement with Distraction | 3.6 scores on a scale | Standard Deviation 0.9 |
| Virtual Reality | Engagement With Distraction and Belief in Distraction's Efficacy | Belief in Distraction's Efficacy | 2.9 scores on a scale | Standard Deviation 1.2 |
| Passive Distraction | Engagement With Distraction and Belief in Distraction's Efficacy | Engagement with Distraction | 2.6 scores on a scale | Standard Deviation 1.1 |
| Passive Distraction | Engagement With Distraction and Belief in Distraction's Efficacy | Belief in Distraction's Efficacy | 2.6 scores on a scale | Standard Deviation 1 |
| Standard Care Provided by the Nurses | Engagement With Distraction and Belief in Distraction's Efficacy | Engagement with Distraction | NA scores on a scale | — |
| Standard Care Provided by the Nurses | Engagement With Distraction and Belief in Distraction's Efficacy | Belief in Distraction's Efficacy | NA scores on a scale | — |
p-value: 0.15Semipartial Correlation
p-value: 0.18Semipartial correlation
p-value: 0.054Semipartial correlation
p-value: 0.61Semipartial Correlation
p-value: 0.007Semipartial Correlation
p-value: 0.045Semipartial correlation