NCT04351776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 10, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

April 3, 2020

Last Update Submit

August 30, 2023

Conditions

Pain, PostoperativePainAnxiety Postoperative

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (11)

  • Effect of VR-biofeedback on anxiety

    Before 10 minute VR session.

  • Effect of VR-biofeedback on anxiety

    After 10 minute VR session. Anxiety will be rated using a visual analog scale.

  • Effect of VR-biofeedback on medication use

    Duration of hospital stay up to 30 days after discharge

  • Effect of VR-distraction on anxiety

    Before 10 minute VR session.

  • Effect of VR-distraction on anxiety

    After 10 minute VR session.

  • +6 more secondary outcomes

Study Arms (3)

VR-Biofeedback

OTHER
Other: VR-Biofeedback

VR-Distraction

OTHER
Other: VR-Distraction

360 Video

OTHER
Other: 360 Video

Interventions

VR-BiofeedbackOTHER

Participants will be instructed to use the Mindful Aurora application

VR-Biofeedback
VR-DistractionOTHER

Participants will be instructed to use one of three applications

VR-Distraction
360 VideoOTHER

Participants will be instructed which video to view

360 Video

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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.

    PMID: 33380482DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Charlotte Walter, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 17, 2020

Study Start

July 10, 2020

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

This information will be made available upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available upon publication. All data will be deidentified.

Locations

US(1)