Virtual Reality to Reduce Pre-Operative Anxiety

Children's Hospital Los Angeles

Status: Suspended

Conditions: Ambulatory Surgery; Mask Induction; IV Stick; Augmented Reality; Anxiety; Pain; Virtual Reality

Treatments: Device: Mira Prism VR; Device: Oculus Go VR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04268914

CHLA-15-00461

Details and patient eligibility

About

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing various procedures in the Ambulatory Surgery Center (ASC) at CHLA, as measured by self- and proxy-report.

Full description

4 million children undergo surgery in the US each year and up to 65% of these children experience significant anxiety and distress before surgery. High anxiety can be traumatic, but it can also lead to postoperative adverse outcomes, such as increased pain and analgesics requirements, delayed hospital discharge, and maladaptive behavioral changes, in children after the surgery. Non-pharmacological intervention, complementary and alternative medicine (CAM) interventions, such as virtual reality, has been shown to decrease anxiety and distress in other medical procedures (e.g., burn care, phlebotomy). Yet to date, no clinical trial has been conducted to examine the effectiveness of virtual reality (VR) to reduce anxiety and distress prior to outpatient surgeries in the operating room setting.

The current study aims to: 1) Determine if VR is more effective than standard care for preventing anxiety, distress, and pain before surgery among children undergoing anesthesia induction, 2) To evaluate healthcare provider's and caregiver's assessment of patient cooperation and caregiver's distress and satisfaction with VR compared to standard of care, and 3) to explore the influence of patient and caregiver characteristics on the effectiveness of VR in preventing pre-operative anxiety and distress and subsequent post-operative outcomes.

Study Population: Children (age 10 - 21 years) and their parents who are scheduled to undergo outpatient surgery, whose health status is American Society of Anesthesiologists (ASA) physical status I-III, and are in the normal range of development are eligible to be in the study.

Study Methodology: The study is a randomized, controlled trial designed to examine the effects of VR on the level of preoperative pain, anxiety and distress of children undergoing surgery.

Statistical Analyses: Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables. Multiple regression analyses will be used to examine the influence of patient and caregiver variables on patient outcomes in the VR group only.

Enrollment: 450 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children who are 10-21 years old
• Children who are English speaking (parents may be Spanish English speaking or Spanish speaking)
• Children who are scheduled to undergo outpatient surgery are eligible to participate in this project.
• Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to patients who are normal and healthy with no known systemic disease. ASA status II refers to patients who have mild or well-controlled systemic diseases, such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies.
• Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the preparation programs and interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.

Exclusion criteria

• Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to patients with an incapacitating systemic disease that is a constant threat to life. ASA status V patients are considered moribund.
• Children who are taking psychotropic medications that affect emotion modulation will be excluded from this study.
• Children with organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
• Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks or use the technological devices
• Children with a history of seizure disorder.
• Children currently sick with flu-like symptoms or experiencing a headache or earache

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Standard of Care (No VR) Randomization

No Intervention group

Description:

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for IV placement and induction of anesthesia. Current standard of care practices at CHLA for outpatient surgery induction will include the following steps. Children may receive midazolam, parental presence during induction and any other intervention or medication chosen by the HCP. The research team will have no input to the decision regarding the use of any therapy.

VR Randomization

Experimental group

Description:

When a child is assigned to the VR condition s/he will have the added component of VR distraction during pre-surgical preparation. Children in the VR condition will interact with an immersive 3D virtual environment presented via a HMD (head-mounted display), a helmet with computer screens for each eye. This study will use two HMDs at two possible time points: (1) Prior to and during IV placement, participants will play using the Oculus Go; (2) Prior to and during anesthesia induction, participants will play using the Mira Prism.

Treatment:

Device: Oculus Go VR

Device: Mira Prism VR