Randomized Controlled Trial of Virtual Reality

February 2, 2023 updated by: Chantel Burkitt, Gillette Children's Specialty Healthcare

Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context

Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • 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 Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • GilletteChildren's Specialty Healthcare

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

Ages Eligible for Study

4 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare

Exclusion Criteria:

  • Patients who are fully anesthetized during their medical procedure
  • Non-English speaking parents/patients
  • Patients with history of motion sickness
  • Patients with epilepsy
  • Patients with a ventricular shunt
  • Patients who have surgery during the study time period

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Reality for distraction
The application of VR during the putative painful treatment (botulinum toxin injections) will provide a) active and engaging distraction during the procedure, and will b) block the view and auditory noise related to the procedure.
Device: Virtual Reality
Participants will have the opportunity to choose a game or relaxation experience to utilize during a botulinum toxin injection to distract from pain and anxiety during one visit. Virtual Reality will not be available during the other visit. AppliedVR has a number of games and relaxation experiences available for participants to chose from.
Other Names:
  • AppliedVR
NO_INTERVENTION: Standard of Care
Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
Time Frame: 2 days
The Faces Pain Scale - Revised (FPS-R) will be used to assess pain intensity before, during, and after the treatment session. The FPS-R is a self-report measure of pain intensity developed for children. This scale shows a serious of six faces depicting increasing intensity of pain expression. The FPS-R instructions orient the child to the series of faces and then ask the child to point to the face that shows how much they hurt right now. Each face corresponds to a numerical rating between 0 and 10 (0, 2, 4, 6, 8, and 10). This rating scale corresponds to the widely accepted 0-to-10 metric for pain. The "0" equals no pain and the "10" equals very much pain. The score is reported as a total score.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.
Time Frame: 2 days
A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale and will assess the following: patient anxiety before, during and after the procedure; parent/caregiver anxiety before, during, and after the procedure; proportion of the treatment time spent thinking about pain; worst pain during treatment; satisfaction with pain management; and nausea during treatment. This will be done at both visits (VR and no-VR).
2 days
Information collected from the medical record (e.g., medication use during procedure).
Time Frame: 2 days
Following the signing of a HIPPA release, the medical record will be accessed to obtain such information as: patient diagnosis, date of birth, ethnicity, number of botulinum toxin injections, muscles injected, patient weight, height, and temperature, heart rate, blood pressure and oxygen saturation during treatment, clinical description of the context of VR use; provider description of whether VR enhanced clinical care; reduction or avoidance of medication due to VR; total amounts of medications given (e.g., valium, nitrous oxide, opioids; mg/kg); and notation of patient side effects from VR. This will be done at both visits (VR and no-VR).
2 days
The Pain Opinion Questionnaire (POQ)
Time Frame: 2 days
The Pain Opinion Questionnaire (POQ) requires caregivers to respond to 5 questions in 3 separate sections regarding children with mild, moderate, and severe/profound intellectual and developmental disabilities. A description of the abilities and limitations of a typical individual with each level of impairment is provided in each section. The questions address 5 facets of pain: (a) the ability of the children to sense painful stimuli (Sensation), (b) how upset or distressed the children feel while in pain (Emotional Reaction), (c) how strongly the children react behaviorally to pain (Behavioral Reaction), (d) how much the children communicate their pain to others (Communication), and (e) how much pain the children suffer (Frequency). We are modifying the scale to require parents or caregivers to estimate whether they believe their child (not a hypothetical child) would experience that aspect of pain the "same as", "less than", or "more than" children without impairment.
2 days
The Dalhousie Pain Interview (DPI)
Time Frame: 2 days
The Dalhousie Pain Interview (DPI) will provide a measure of pain experience in the previous week, including pain frequency (number of pain episodes), intensity (rated 0-10) and duration (number of seconds or minutes in pain). The measure consists of 10 items and was designed explicitly as an interview/survey script.
2 days
The Brief Pain Inventory (BPI)
Time Frame: 2 days
The Brief Pain Inventory (BPI) will provide a measure of pain interference in the previous week (i.e., the degree to which ongoing pain interferes with daily living). The BPI is a 10-item, 11-point scale (0 = does not interfere, 10 = completely interferes). The items include general activity, mood, mobility, normal work, relationships with other people, sleep, enjoyment of life, self-care, recreational activities, and social activities. Total score (sum of all 12 items combined; range 0-120) and average score (average item score; range 0-10) will be assessed.
2 days

Collaborators and Investigators

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

Sponsor

Gillette Children's Specialty Healthcare

Investigators

  • Principal Investigator: Chantel Burkitt, PhD, Gillette Children's Specialty Healthcare

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)

September 21, 2018

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GilletteCSH

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

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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