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This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.
Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Participants will experience Virtual Reality during their cast removal |
|
| Standard of care | No Intervention | Participants will receive their usual standard of care treatment during cast removal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality (VR) | Device | Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline heart rate during cast removal procedure | The change from baseline heart rate during cast removal procedure obtained by using an electronic monitoring wristband and measuring heart rate 15 seconds prior to and continuously during the cast removal procedure. | Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Parent Reported Wong-Baker FACES Pain Scale Rating | Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain. | The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew G Georgiadis, MD | Contact | 651-602-3262 | andrewgeorgiadis@gillettechildrens.com | |
| Christine K Santa Ana, BS | Contact | 651-229-1763 | ChristineKSantaAna@gillettechildrens.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew G Georgiadis, MD | Pediatric Orthopedic Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gillette Children's Specialty Healthcare | Recruiting | Saint Paul | Minnesota | 55101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26177059 | Background | Naranje SM, Erali RA, Warner WC Jr, Sawyer JR, Kelly DM. Epidemiology of Pediatric Fractures Presenting to Emergency Departments in the United States. J Pediatr Orthop. 2016 Jun;36(4):e45-8. doi: 10.1097/BPO.0000000000000595. | |
| 8673584 | Background | Wiggins CE, Brown KD. Hearing protection and cast saw noise. J South Orthop Assoc. 1996 Spring;5(1):1-4. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2024 | Nov 26, 2024 | 4 |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Change in Patient Reported Wong-Baker FACES Pain Scale Rating | Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain. | The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Parental anxiety during cast removal | Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety. | The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Patient anxiety during cast removal | Patient anxiety regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety. | The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Parental Satisfaction | Parental satisfaction regarding the cast removal will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased satisfaction. | The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Parental Assessment of Pleasantness | Parental report of how pleasant the cast removal was. Self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pleasantness. | The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment | Parental report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain. | The VAS parental worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment | Patient report of the highest level of pain experienced by the child during the cast removal. Reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased pain. | The VAS patient worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods. |
| 11341425 | Background | Katz K, Fogelman R, Attias J, Baron E, Soudry M. Anxiety reaction in children during removal of their plaster cast with a saw. J Bone Joint Surg Br. 2001 Apr;83(3):388-90. doi: 10.1302/0301-620x.83b3.10487. |
| 23752160 | Background | Post JM, Switzer KD, Brown DK, Meinzen-Derr J, Dively J, Dunkin BS, Mehlman CT. Cast saw noise does not reach occupational hazard levels. J Pediatr Orthop. 2013 Jul-Aug;33(5):580-4. doi: 10.1097/BPO.0b013e318288b5e4. |
| 17878794 | Background | Liu RW, Mehta P, Fortuna S, Armstrong DG, Cooperman DR, Thompson GH, Gilmore A. A randomized prospective study of music therapy for reducing anxiety during cast room procedures. J Pediatr Orthop. 2007 Oct-Nov;27(7):831-3. doi: 10.1097/BPO.0b013e3181558a4e. |
| 29980545 | Background | Wong CL, Ip WY, Kwok BMC, Choi KC, Ng BKW, Chan CWH. Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. BMJ Open. 2018 Jul 5;8(7):e021071. doi: 10.1136/bmjopen-2017-021071. |
| 15707139 | Background | Carmichael KD, Westmoreland J. Effectiveness of ear protection in reducing anxiety during cast removal in children. Am J Orthop (Belle Mead NJ). 2005 Jan;34(1):43-6. |
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