Virtual Reality During Pediatric Cast Removal

February 10, 2021 updated by: Andrew G. Geoergiadis, Gillette Children's Specialty Healthcare

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality
Participants will experience Virtual Reality during their cast removal
Device: Virtual Reality (VR)
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Other Names:
  • AppliedVR
No Intervention: Standard of care
Participants will receive their usual standard of care treatment during cast removal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gillette Children's Specialty Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew G Georgiadis, MD, Pediatric Orthopedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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