Virtual Reality for Appendectomy Pain

NCT ID: NCT04357132

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-12

Study Completion Date

2021-08-30

Brief Summary

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

Detailed Description

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Conditions

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Appendix Rupture Pain Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VR-Biofeedback

Group Type OTHER

VR-Biofeedback

Intervention Type OTHER

Participants will be instructed to use the Mindful Aurora Application

VR-Distraction

Group Type OTHER

VR-Distraction

Intervention Type OTHER

Participants will be instructed to use one of four applications

Interventions

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VR-Biofeedback

Participants will be instructed to use the Mindful Aurora Application

Intervention Type OTHER

VR-Distraction

Participants will be instructed to use one of four applications

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Olbrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2020-0258

Identifier Type: -

Identifier Source: org_study_id

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