VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

NCT ID: NCT03464955

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2023-07-11

Brief Summary

Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.

Detailed Description

Anxiety among children undergoing non-invasive surgical subspecialty procedures is common. Not only is high anxiety traumatic, but research in a surgical setting indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors that may arise when experiencing a non-invasive surgical subspecialty procedure in a clinical setting.

In this study, investigators hope to determine if technology based distractions (VR headsets with headphones, AR headset, or BERT projector) are more effective than standard care for preventing high anxiety before non-invasive surgical subspecialty procedures. As a secondary objective of the study, the investigators seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction as well as evaluate which techniques are most effective. As a tertiary aim, the investigators seek to understand if passive or active interventions are more effective in decreasing anxiety.

Conditions

Stress, Emotional; Stress, Psychological; Behavioral Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

The control group will be provided standard of care, which is no use of technologies.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group with Passive Content

Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures.

Group Type: EXPERIMENTAL

Technology Based Distractions

Intervention Type: BEHAVIORAL

Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Intervention Group with Active Content

Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures.

Group Type: EXPERIMENTAL

Technology Based Distractions

Intervention Type: BEHAVIORAL

Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Interventions

Technology Based Distractions

Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Be between ages of 2-18 years of age

2. Have comprehension of instructions in the English language

3. Have parental consent

4. Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic

5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)

Exclusion Criteria

1. Significant cognitive impairment/developmental delays per parental report or H&P.

2. Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24 hours or without the operation)

3. Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation

4. Strong parental or patient preference for pharmacological anxiolytic

5. Strong parental or patient preference for specific anxiety-reducing technique

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Samuel Rodriguez

Assistant Professor, Department of Anesthesiology, Perioperative and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Countries

United States

Other Identifiers

42351

Identifier Type: -

Identifier Source: org_study_id