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Randomized Controlled Trial of Virtual Reality

Sponsor
Gillette Children's Specialty Healthcare (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03521076
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
50.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants who are having botulinum toxin injections will be enrolled in the study. We will use a crossover study design, such that participants will access VR in addition to standard of care in one session and then experience only standard of care in the other condition. Participants will be randomized following the consent process. The participants will experience the opposite condition at their 2nd visit.Participants who are having botulinum toxin injections will be enrolled in the study. We will use a crossover study design, such that participants will access VR in addition to standard of care in one session and then experience only standard of care in the other condition. Participants will be randomized following the consent process. The participants will experience the opposite condition at their 2nd visit.
Masking:
Single (Outcomes Assessor)
Masking Description:
Researcher #1 will break the blind and know which condition the participant is in. Researcher #1 will then be the one to video record the treatment session. Researcher #1 will leave the room immediately following the treatment intervention. Researcher #2 will enter the room and will support the patient, parent/caregiver, and provider in completing outcomes assessments.
Primary Purpose:
Supportive Care
Official Title:
Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context
Actual Study Start Date :
Sep 21, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections. [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.

    Secondary Outcome Measures

    1. A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR. [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. Information collected from the medical record (e.g., medication use during procedure). [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).

    3. The Pain Opinion Questionnaire (POQ) [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.

    4. The Dalhousie Pain Interview (DPI) [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.

    5. The Brief Pain Inventory (BPI) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GilletteChildren's Specialty Healthcare Saint Paul Minnesota United States 55101

    Sponsors and Collaborators

    • Gillette Children's Specialty Healthcare

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chantel Barney, Clinical Scientist, Gillette Children's Specialty Healthcare
    ClinicalTrials.gov Identifier:
    NCT03521076
    Other Study ID Numbers:
    • GilletteCSH
    First Posted:
    May 11, 2018
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Chantel Barney, Clinical Scientist, Gillette Children's Specialty Healthcare
    Botulinum Toxin Injections
    Virtual Reality
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of Jul 27, 2021