Clinical trial NCT04351776: Virtual Reality and Pain
Official title: Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain
Anxiety Postoperative
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Primary purpose: OTHER

Brief summary: Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Ages 8 - 18 years
* Able to read, understand and speak English
* Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service

Exclusion Criteria:

* Outside the age range (\< 8 or \> 18 years)
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorder
* Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck

Primary outcomes:
measure: Effect of VR-biofeedback on pain
timeFrame: Postoperatively 24 - 90 hours.
measure: Effect of VR-distraction on pain
timeFrame: Postoperatively 24 - 90 hours.
measure: Effect of 360 video on pain
timeFrame: Postoperatively 24 - 90 hours.
Secondary outcomes:
measure: Effect of VR-biofeedback on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of VR-biofeedback on anxiety
timeFrame: After 10 minute VR session. Anxiety will be rated using a visual analog scale.
measure: Effect of VR-biofeedback on medication use
timeFrame: Duration of hospital stay up to 30 days after discharge
measure: Effect of VR-distraction on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of VR-distraction on anxiety
timeFrame: After 10 minute VR session.
measure: Effect of VR-distraction on medication use
timeFrame: Duration of hospital stay up to 30 days after discharge
measure: Effect of 360 video on anxiety
timeFrame: Before 10 minute VR session.
measure: Effect of 360 video on anxiety
timeFrame: After 10 minute VR session.
measure: Effect of 360 video on medication use
timeFrame: Duration of hospital stay up to 30 days after discharge
measure: Role of anxiety on changes in pain
timeFrame: One time prior to study visit
measure: Role of pain catastrophizing
timeFrame: One time prior to study visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Charlotte Walter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olbrecht VA, Williams SE, O'Conor KT, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). BMJ Open. 2020 Dec 30;10(12):e040295. doi: 10.1136/bmjopen-2020-040295.