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Randomized Controlled Trial of Virtual Reality

NCT03521076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-02-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Gillette Children's Specialty Healthcare

    lead OTHER

Principal Investigators

  • Chantel Burkitt, PhD · Gillette Children's Specialty Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2023-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03521076 on ClinicalTrials.gov