Anxiety Postoperative, Pain, Pain, Postoperative
Conditions
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.
Interventions
OTHER360 Video
Participants will be instructed which video to view
OTHERVR-Biofeedback
Participants will be instructed to use the Mindful Aurora application
OTHERVR-Distraction
Participants will be instructed to use one of three applications
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VR-biofeedback on pain | Postoperatively 24 - 90 hours. | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. |
| Effect of VR-distraction on pain | Postoperatively 24 - 90 hours. | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. |
| Effect of 360 video on pain | Postoperatively 24 - 90 hours. | Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of VR-distraction on medication use | Duration of hospital stay up to 30 days after discharge | Medications used will be collected |
| Effect of 360 video on anxiety | Before 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
| Effect of VR-biofeedback on anxiety | Before 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety. |
| Role of anxiety on changes in pain | One time prior to study visit | Participants will complete a questionnaire regarding anxiety |
| Role of pain catastrophizing | One time prior to study visit | Participants will complete a questionnaire regarding pain |
| Effect of 360 video on medication use | Duration of hospital stay up to 30 days after discharge | Medications used will be collected |
| Effect of VR-biofeedback on medication use | Duration of hospital stay up to 30 days after discharge | Medications used will be collected |
| Effect of VR-distraction on anxiety | Before 10 minute VR session. | Anxiety scores will be collected. Anxiety will be rated using a visual analog scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
Countries
United States
Outcome results
None listed