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NCT Number: NCT03903510

Virtual Reality During Pediatric Cast Removal

This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.

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Key information

Conditions

Fractures, Bone Wounds and Injuries

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location status: Recruiting

Location contact

Andrew G Georgiadis, MD

CONTACT

[email protected]

651-602-3262

Andrew G Georgiadis, MD

PRINCIPAL_INVESTIGATOR

Christine K Santa Ana, BS

CONTACT

[email protected]

651-229-1763

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sustained a fracture in their arm/leg
  • No previous experience with a cast removal
  • Must have at least one wrist free of immobilization (for heart rate monitor)
  • Parents and patient are English speaking

Exclusion criteria

  • Patients with a history of epilepsy, ventricular shunt, motion sickness
  • Patients with any history of cognitive, visual or hearing impairment

Treatment and study plan

Virtual reality (VR)

Device

Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.

Other names: AppliedVR

Primary outcomes

  1. Change from baseline heart rate during cast removal procedure

    Time frame: 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.

    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.

Secondary outcomes

  1. Change in Parent Reported Wong-Baker FACES Pain Scale Rating

    Time frame: 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.

    Parent reported pain scale that is rated from 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.

  2. Change in Patient Reported Wong-Baker FACES Pain Scale Rating

    Time frame: 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.

    Patient reported pain scale that is rated on a scale of 0 (minimum) to 10 (maximum), where a higher number indicates increased pain.

  3. Visual Analog Scale (VAS): Parental anxiety during cast removal

    Time frame: 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.

    Parental anxiety will be self reported using a 0 (minimum) to 100 (maximum) scale, where a higher number indicates increased anxiety.

  4. Visual Analog Scale (VAS): Patient anxiety during cast removal

    Time frame: 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.

    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.

  5. Visual Analog Scale (VAS): Parental Satisfaction

    Time frame: 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.

    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.

  6. Visual Analog Scale (VAS): Parental Assessment of Pleasantness

    Time frame: 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.

    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.

  7. Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment

    Time frame: 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.

    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.

  8. Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment

    Time frame: 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew G Georgiadis, MD

CONTACT

[email protected]

651-602-3262

Christine K Santa Ana, BS

CONTACT

[email protected]

651-229-1763

Sponsors and collaborators

Lead sponsor

Gillette Children's Specialty Healthcare

Other

Registry information

Official study title

A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2019
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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