FOREVR Peds VR Pilot

NCT ID: NCT04556747

Last Updated: 2021-09-24

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-03-11

Brief Summary

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To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.

Detailed Description

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Conditions

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Pain, Postoperative Pain Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VR - Distraction

Group Type OTHER

VR - Distraction

Intervention Type OTHER

Participants will be instructed to use any application.

VR - Biofeedback

Group Type OTHER

VR - Biofeedback

Intervention Type OTHER

Participants will be instructed to use the Mindful Aurora application.

Interventions

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VR - Distraction

Participants will be instructed to use any application.

Intervention Type OTHER

VR - Biofeedback

Participants will be instructed to use the Mindful Aurora application.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages 7to 21 years
* Able to read, understand, and speak English
* Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
* Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis

Exclusion Criteria

* Outside the age range (\< 7 or \> 21 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 glasses, such as surgeries of the head and neck
Minimum Eligible Age

7 Years

Maximum Eligible Age

21 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

Cincinnati Childrens Hospital Medical Center

Locations

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Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Olbrecht VA, O'Conor KT, Williams SE, Boehmer CO, Marchant GW, Glynn SM, Geisler KJ, Ding L, Yang G, King CD. Guided Relaxation-Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study. J Med Internet Res. 2021 Jul 12;23(7):e26328. doi: 10.2196/26328.

Reference Type DERIVED
PMID: 34048358 (View on PubMed)

Other Identifiers

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2018-2892

Identifier Type: -

Identifier Source: org_study_id

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