VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

Stress, Psychological Clinical Trial

Official title:

Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464955
• Other study ID #: 42351
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: July 11, 2023

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: July 11, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Symptoms
• Stress, Emotional
• Stress, Psychological

Intervention

Behavioral:
• Technology Based Distractions
Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Score	Peak Pain Score minus Baseline Pain Score. Pain scores range from 0 to 10. 0 represents no pain and 10 represents the worst pain possible. Change in pain score ranges from +10 to -10. Higher positive values represent a worse outcome, and higher negative values represent a better outcome.	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary	Anxiety Score	Fear Faces. Images of faces depicting increasing levels of fear measure the degree of fear the patient is experiencing. Faces correlate to a score ranging from 0 to 4. 0 represents the least scared and 4 represents the most scared. Higher values represent a worse outcome.	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary	Anxiety Meter	Childhood Anxiety Meter	Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary	Family Satisfaction	Family Satisfaction Survey	Immediately Post Non-Invasive Surgical Subspecialty Procedure
Secondary	Patient Satisfaction	Patient Satisfaction Survey	Immediately Post Non-Invasive Surgical Subspecialty Procedure
Secondary	Patient Cooperation	Brief Behavioral Distress Scale (BBDS). Measures patient cooperation. Behavior cooperation choices exist on a scale consisting of non-interfering behaviors, potentially-interfering behaviors and interfering behaviors. Non-Interfering Behaviors = minor, verbal/vocal distress, moan, comfort seeking, etc. Potentially Interfering Behaviors = intense verbal/vocal distress, scream, shout, tensing of muscles, clench, flinch, gritting of teeth, etc.Interfering Behaviors = escape, disrupt, avoid, aggress, etc. Interfering behaviors represent a worse outcome.	At the time of Non-Invasive Surgical Subspecialty Procedure
Secondary	Patient Compliance	Modified Induction Compliance Checklist	At the time of Non-Invasive Surgical Subspecialty Procedure
Secondary	Parent Pain Catastrophizing Scale (PCS-P)	PCS-P. Measures the extent of thought concerning pain Scale ranges from 1 to 5. 1 represents not thinking at all about pain and 5 represents thinking very much about pain. Higher values represent a worse outcome.	Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure