Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-01-01

Brief Summary

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This study aims to investigate the use of virtual reality guided mindfulness meditation to reduce the pre and post-operative anxiety and pain of pediatric surgical patients.

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Detailed Description

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Pre-procedural anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Post-procedural pain has been shown to negatively impact future interactions with healthcare personnel. The purpose of this study is to determine the feasibility of using guided mindfulness meditation through a non-invasive device (virtual reality headset) to manage pre-procedure anxiety and post-procedure anxiety and pain.

Conditions

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Anxiety Pain Pain, Postoperative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective observational study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Virtual Reality Headset Given

Virtual Reality headset (Samsung Gear VR) with mindfulness meditation app is given for patient use prior to surgery date and for duration of postoperative stay.

Group Type EXPERIMENTAL

Virtual Reality Headset Given

Intervention Type DEVICE

Samsung Gear VR Headset with guided mindfulness meditation app

Interventions

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Virtual Reality Headset Given

Samsung Gear VR Headset with guided mindfulness meditation app

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have parental consent if under 18 or 18 and older but unable to provide own consent
* Can comprehend instructions in English language
* Is undergoing surgical procedure requiring general anesthesia at Lucile Packard Children's Hospital
* Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II, III)

Exclusion Criteria

* Children with significant cognitive impairment or developmental delays per parental report or H\&P
* Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive \>24hours or without operation)
* Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
* Children with history of seizures related to photosensitivity.

Minimum Eligible Age

5 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No