NCT04357132

Brief Summary

To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

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 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

April 17, 2020

Last Update Submit

February 6, 2023

Conditions

Appendix RupturePainPain, Postoperative

Outcome Measures

Primary Outcomes (12)

  • Effect on 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 on VR-biofeedback on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    Immediately after VR session.

  • Effect on VR-biofeedback on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    15 minutes after VR session.

  • Effect on VR-biofeedback on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    30 minutes after VR session.

  • 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-biofeedback on medication use

    Amount of pain medications used will be collected

    24-90 hours

  • Effect of VR-distraction on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating 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 numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    Immediately after 10 minute VR session.

  • Effect of VR-distraction on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    15 minutes after 10 minute VR session.

  • Effect of VR-distraction on anxiety

    Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.

    30 minutes after 10 minute VR session.

  • 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 VR-distraction on medication use

    Pain medications used will be collected

    24-90 hours

Secondary Outcomes (2)

  • Role of anxiety on changes in pain

    One time prior to study visit

  • Role of pain catastrophizing

    One time prior to study visit

Study Arms (2)

VR-Biofeedback

OTHER
Other: VR-Biofeedback

VR-Distraction

OTHER
Other: VR-Distraction

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 four applications

VR-Distraction

Eligibility Criteria

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

You may qualify if:

  • Age 8 - 18 years
  • Able to read, understand, and speak English
  • Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix

You may not qualify if:

  • Outside of 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 disorders
  • Conditions that would preclude the application of the VR headset, such as craniofacial deformities
  • History of chronic pain, frequent opioid use and/or active cancer therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Vanessa Olbrecht, 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: 60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 22, 2020

Study Start

July 12, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

US(1)