Clinical trial NCT03521076: Randomized Controlled Trial of Virtual Reality
Official title: Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Spasticity
Keywords: Botulinum Toxin Injections
Virtual Reality
Lead sponsor: Gillette Children's Specialty Healthcare
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 49
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
timeFrame: 2 days
Secondary outcomes:
measure: A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.
timeFrame: 2 days
measure: Information collected from the medical record (e.g., medication use during procedure).
timeFrame: 2 days
measure: The Pain Opinion Questionnaire (POQ)
timeFrame: 2 days
measure: The Dalhousie Pain Interview (DPI)
timeFrame: 2 days
measure: The Brief Pain Inventory (BPI)
timeFrame: 2 days
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: GilletteChildren's Specialty Healthcare
state: Minnesota
Study officials:
affiliation: Gillette Children's Specialty Healthcare
name: Chantel Burkitt, PhD
role: PRINCIPAL_INVESTIGATOR
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