Longitudinal Virtual Reality Use in Pediatric Surgical Procedures

Stanford University

Status: Withdrawn

Conditions: Pain, Postoperative; Anxiety; Pain

Treatments: Device: Virtual Reality Headset Given

Study type: Interventional

Funder types: Other

Identifiers

NCT03832478

46879

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Virtual Reality Headset Given

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality Headset Given