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Randomized Controlled Trial of Virtual Reality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03521076
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2018
Last Update Posted : June 5, 2020
Information provided by (Responsible Party):
Chantel Barney, Gillette Children's Specialty Healthcare

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
Muscle Spasticity Device: Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 21, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: AppliedVR

No Intervention: Standard of Care
Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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. 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).

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03521076

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United States, Minnesota
GilletteChildren's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
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Principal Investigator: Chantel Barney, PhD Gillette Children's Specialty Healthcare

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Responsible Party: Chantel Barney, Clinical Scientist, Gillette Children's Specialty Healthcare Identifier: NCT03521076    
Other Study ID Numbers: GilletteCSH
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Chantel Barney, Gillette Children's Specialty Healthcare:
Botulinum Toxin Injections
Virtual Reality
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases