Randomized Controlled Trial of Virtual Reality

Gillette Children's

Status: Active, not recruiting

Conditions: Muscle Spasticity

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03521076

GilletteCSH

Details and patient eligibility

About

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.

Enrollment: 49 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Virtual Reality for distraction

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Standard of Care

No Intervention group

Description:

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