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Early termination of study due to fewer subjects available than expected resulting in small sample size.
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| Name | Class |
|---|---|
| Arkansas Children's Hospital Research Institute | OTHER |
| Arkansas Biosciences Institute | UNKNOWN |
| Arkansas Children's Hospital Burn Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Virtual reality using a software program designed for burn patients during burn wound care |
|
| Passive distraction | Active Comparator | watching a movie |
|
| UC provided by the nurses | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device |
| ||
| Passive Distraction |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within the first 20 minutes following completion of the burn wound care procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Desire for Distraction | Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire | Post-procedure (approximately 30-75 minutes) |
| Engagement With Distraction and Belief in Distraction's Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra A Jeffs, PhD, RN | Arkansas Children's Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Askay SW, Patterson DR. What are the psychiatric sequelae of burn pain? Curr Pain Headache Rep. 2008;12(2):94-97. Das DA, Grimmer KA, Sparnon AL, et al. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial. BMC Pediatr. 2005;5(1):1471-2431. Patterson DR, Weichman SA, Jensen MP, et al. Hypnosis delivered through immersive virtual reality for burn pain: a clinical case series. Int J Clin Exp Hypn. 2006;54(2):130-142. Hoffman HG, Chambers GT, Meyer WJ, et al. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann. Behav. Med. 2011;41(2):183-191. doi: 10.1007/s12160-010-9248-7. Smith JS, Smith KR, Rainey SL. The psychology of burn care. J Trauma Nurs. 2006;13(3):105-106. |
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One participant was re-assigned to standard care prior to group assignment when the virtual reality (VR) equipment failed during set-up.
Participants recruited from 6/2010 until 4/2012 in the outpatient Burn Center clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality | Virtual reality using a software program designed for burn patients during burn wound care |
| BG001 | Passive Distraction | watching a movie |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intention to treat | Posted | Least Squares Mean | 95% Confidence Interval | mm | Within the first 20 minutes following completion of the burn wound care procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality | Virtual reality using a software program designed for burn patients during burn wound care |
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Early termination of study due to fewer subjects available than expected resulting in small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Jeffs, PhD, RN, Principal Investigator | Arkansas Children's Hospital | 501-364-3239 | jeffsda@archildrens.org |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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) |
| Post-procedure (approximately 30-75 minutes) |
| BG002 | Standard Care Provided by the Nurses |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| STAIC - State Anxiety | Participants self-rated 20 statements about how the individual feels at the present moment with responses provided on a three-point rating scale. Total scores on the scale range from 20-60. | Mean | Standard Deviation | Scores on a scale |
|
| STAIC - Trait Anxiety | Participants self-rated 20 statements on a three-point rating scale that best described how the person usually feels. Total scores on the scale range from 20-60. | Mean | Standard Deviation | Scores on a scale |
|
| Pre-Procedure Pain | Participants rated pre-procedure pain on the Adolescent Pediatric Pain Tool word graphic rating scale with no pain and worst possible pain as anchors on the 0-100mm scale. | Mean | Standard Deviation | Score on a scale |
|
watching a movie
| OG002 | Standard Care Provided by the Nurses |
|
|
|
| Secondary | Desire for Distraction | Participants were asked "I wanted to be distracted from during my treatment today." (Agree-Disagree) from the Post-Procedure Questionnaire | Posted | Number | participants | Post-procedure (approximately 30-75 minutes) |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | scores on a scale | Post-procedure (approximately 30-75 minutes) |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Passive Distraction | watching a movie | 0 | 30 | 0 | 30 |
| EG002 | UC Provided by the Nurses | 0 | 30 | 0 | 30 |
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| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Did not Answer Question |
|
| .59 |
| Semipartial correlation |
| 0.119 |
| 95 |
Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants |
| No |
| Superiority or Other |
| Semipartial correlation | .60 | Semipartial correlation | -0.059 | 95 | Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants | No | Superiority or Other |
| Belief in Distraction's Efficacy |
|
| 0.18 |
| Semipartial correlation |
| -0.347 |
| 95 |
Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants |
| No |
| Superiority or Other |
| Semipartial correlation | 0.054 | Semipartial correlation | 0.210 | 95 | Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants | No | Superiority or Other |
| Semipartial Correlation | 0.61 | Semipartial Correlation | -0.102 | 95 | Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants | No | Superiority or Other |
| Semipartial Correlation | 0.007 | Semipartial Correlation | -0.622 | 95 | Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants | No | Superiority or Other |
| Semipartial correlation | 0.045 | Semipartial correlation | -0.217 | 95 | Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants | No | Superiority or Other |