Randomized Controlled Trial of Virtual Reality

NCT03521076 | Unknown FDA Device

• 1 other identifier: GilletteCSH
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity

Keywords

Botulinum Toxin Injections; Virtual Reality

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (5)

• A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.

  2 days

• Information collected from the medical record (e.g., medication use during procedure).

  2 days

• The Pain Opinion Questionnaire (POQ)

  2 days

• The Dalhousie Pain Interview (DPI)

  2 days

• The Brief Pain Inventory (BPI)

  2 days

Study Arms (2)

Virtual Reality for distraction

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).

Interventions

Virtual Reality DEVICE

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.

Also known as: AppliedVR

Virtual Reality for distraction

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead

Study Sites (1)

GilletteChildren's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

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MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chantel Burkitt, PhD

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 11, 2018
• Study Start: September 21, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)