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Virtual Reality for Appendectomy Pain

Primary Purpose

Appendix Rupture, Pain, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR-Biofeedback
VR-Distraction
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Appendix Rupture

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

VR-Biofeedback

VR-Distraction

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Effect of VR-biofeedback on medication use
Amount of pain medications used will be collected
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.
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.
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.
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.
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.
Effect of VR-distraction on medication use
Pain medications used will be collected

Secondary Outcome Measures

Role of anxiety on changes in pain
Participants will complete a questionnaire regarding anxiety
Role of pain catastrophizing
Participants will complete a questionnaire regarding pain

Full Information

First Posted
April 17, 2020
Last Updated
February 6, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04357132
Brief Title
Virtual Reality for Appendectomy Pain
Official Title
Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendix Rupture, Pain, Pain, Postoperative

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR-Biofeedback
Arm Type
Other
Arm Title
VR-Distraction
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
VR-Biofeedback
Intervention Description
Participants will be instructed to use the Mindful Aurora Application
Intervention Type
Other
Intervention Name(s)
VR-Distraction
Intervention Description
Participants will be instructed to use one of four applications
Primary Outcome Measure Information:
Title
Effect on VR-biofeedback on anxiety
Description
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.
Time Frame
Before 10 minute VR session.
Title
Effect on VR-biofeedback on anxiety
Description
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.
Time Frame
Immediately after VR session.
Title
Effect on VR-biofeedback on anxiety
Description
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.
Time Frame
15 minutes after VR session.
Title
Effect on VR-biofeedback on anxiety
Description
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.
Time Frame
30 minutes after VR session.
Title
Effect of VR-biofeedback on pain
Description
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.
Time Frame
Postoperatively 24 - 90 hours.
Title
Effect of VR-biofeedback on medication use
Description
Amount of pain medications used will be collected
Time Frame
24-90 hours
Title
Effect of VR-distraction on anxiety
Description
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.
Time Frame
Before 10 minute VR session.
Title
Effect of VR-distraction on anxiety
Description
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.
Time Frame
Immediately after 10 minute VR session.
Title
Effect of VR-distraction on anxiety
Description
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.
Time Frame
15 minutes after 10 minute VR session.
Title
Effect of VR-distraction on anxiety
Description
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.
Time Frame
30 minutes after 10 minute VR session.
Title
Effect of VR-distraction on pain
Description
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.
Time Frame
Postoperatively 24 - 90 hours.
Title
Effect of VR-distraction on medication use
Description
Pain medications used will be collected
Time Frame
24-90 hours
Secondary Outcome Measure Information:
Title
Role of anxiety on changes in pain
Description
Participants will complete a questionnaire regarding anxiety
Time Frame
One time prior to study visit
Title
Role of pain catastrophizing
Description
Participants will complete a questionnaire regarding pain
Time Frame
One time prior to study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 8 - 18 years Able to read, understand, and speak English Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Olbrecht, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality for Appendectomy Pain

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