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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-Biofeedback | Other |
| |
| VR-Distraction | Other |
| |
| 360 Video | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR-Biofeedback | Other | Participants will be instructed to use the Mindful Aurora application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of VR-biofeedback on pain | 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. | Postoperatively 24 - 90 hours. |
| Effect of VR-distraction on pain | 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. | Postoperatively 24 - 90 hours. |
| Effect of 360 video on pain | 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. | Postoperatively 24 - 90 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of VR-biofeedback on anxiety | 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. | Before 10 minute VR session. |
| Effect of VR-biofeedback on anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Walter, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33380482 | Derived | 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. |
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This information will be made available upon request.
Data will become available upon publication. All data will be deidentified.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
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| VR-Distraction | Other | Participants will be instructed to use one of three applications |
|
| 360 Video | Other | Participants will be instructed which video to view |
|
Anxiety scores will be collected. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety |
| After 10 minute VR session. Anxiety will be rated using a visual analog scale. |
| Effect of VR-biofeedback on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge |
| Effect of VR-distraction on anxiety | 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 | Before 10 minute VR session. |
| Effect of VR-distraction on anxiety | 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 | After 10 minute VR session. |
| Effect of VR-distraction on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge |
| Effect of 360 video on anxiety | 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 | Before 10 minute VR session. |
| Effect of 360 video on anxiety | 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 | After 10 minute VR session. |
| Effect of 360 video on medication use | Medications used will be collected | Duration of hospital stay up to 30 days after discharge |
| Role of anxiety on changes in pain | Participants will complete a questionnaire regarding anxiety | One time prior to study visit |
| Role of pain catastrophizing | Participants will complete a questionnaire regarding pain | One time prior to study visit |
| D012816 | Signs and Symptoms |