Virtual Reality to Reduce Pre-Operative Anxiety

Children's Hospital Los Angeles450 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

450

Conditions

Virtual Reality Augmented Reality IV Stick Mask Induction Ambulatory Surgery Pain Anxiety

Interventions

Oculus Go VRDEVICE

The Oculus Go is a standalone headset with built-in speakers that runs independently of a smartphone. Via the Oculus Go, participants will engage with BearBlast (developed by AppliedVR). Throughout the world, plush moles play the role of antagonist, standing in for the nuisance and distraction of pain. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. The VR HMD runs independently of a smartphone and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.

Mira Prism VRDEVICE

The Mira Prism is a portable, augmented reality (AR) HMD powered by iPhone. When paired with the iPhone, the Mira Prism goggles can superimpose computer-generated images on the user's view of the real world. Unlike the full immersion of VR, AR allows users to view the outside world while interacting with digital content. In this study, the patient will interact with Magic Mallet (developed by Miney Moe) until falling asleep during the anesthesia induction process. Magic Mallet is a distraction game designed for pain management and communication during procedures. The game automatically adjusts cognitive load for optimal effect for users. Study team iPhones specifically loaded with Magic Mallet, and without cellular capability, will be used with the Mira Prism.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

VAS anticipatory anxiety measure

The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children.

Time frame: Approximately 5 minutes to one hour before procedure

STAI-C (if elementary or junior high aged), STAI-Y (if in high school or college)

The STAIC is a self-administered measure of anxiety in children. It is comprised of separate, self-report scales for measuring two distinct anxiety concepts: state anxiety (A-State) and trait anxiety (A-Trait). The STAI-C distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state. The instrument consists of two 20-item scales. In the current study, the measure will be used to measure both state and trait anxiety. The STAI is the validated instrument for measuring anxiety in in elementary and junior high aged children.

Time frame: Approximately 5 minutes to one hour before procedure

Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older

The Childhood Anxiety Sensitivity Index (CASI): CASI is an 18-item scale that measures the tendency to view anxiety-related bodily sensations as dangerous (e.g., ''It scares me when my heart beats fast''). Items are scored on a 3-point scale (none, some, a lot), and total scores are calculated by summing all items. The CASI has demonstrated high internal consistency and adequate test-retest reliability. The CASI correlates well with measures of trait anxiety but also accounts for variance in fear not attributable to trait anxiety measures.

Time frame: Approximately 5 minutes to one hour before procedure

The Faces Pain Scale (FPS-R)

Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.

Data from ClinicalTrials.gov

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Time frame: Approximately 5 minutes to one hour before procedure

Child Satisfaction Questionnaire

The child survey is 13-item, Likert-like survey to assess child estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction; it mirrors the parent survey. There are two versions, one for each treatment condition. Two versions of the survey exist, to account for condition (VR vs. standard of care).

Time frame: Approximately 5-15 minutes after procedure

CAMPIS-R

The CAMPIS-R is a standardized rating scale that codes videotaped verbal interactions in the pediatric treatment room. The CAMPIS-R codes the subject, speaker, phase of medical procedure, verbal content, affective tone, and to whom vocalizations are directed. Adult vocalizations are coded as coping-promoting (nonprocedural talk or humor directed to the child, commands to engage in coping strategies), distress-promoting (reassuring comments, apologies, giving control to the child, criticism, and empathetic statements), or neutral (humor to adults, nonprocedural talk to adults, child's condition talk, commands for procedural activity, praise, notification of procedure to come, behavioral commands to child, checking child's status).

Time frame: Peri-procedure

Yale Preoperative Anxiety Scale (m-YPAS; Kain et al., 1995; Kain et al., 1997)

The YPAS consists of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). This measure takes approximately 5-10 minutes to complete. The 'adjusted YPAS total score' ranges from 0 to 100 with higher scores indicating greater anxiety. The YPAS was developed originally to measure the anxiety of children while undergoing induction of anesthesia. Recently, we validated the YPAS against a self-report measure, the State Trait Anxiety Inventory for Children (Kain et al., 1997; STAIC). Data Obtained: Standard scores for the anxiety level of children during the perioperative period.

Time frame: Peri-procedure

Parent Anxiety Scale

The parent is asked to indicate "how nervous, afraid, or worried" they believe their child was about the task on a scale of 1 to 10, from least to most anxious. (See description of Child Anticipatory/Procedural Anxiety)

Time frame: Approximately 5 minutes to one hour before procedure

STAI

The STAI is a self-administered measure of anxiety in adults. It is comprised of separate, self-report scales for measuring two distinct anxiety concepts: state anxiety (A-State) and trait anxiety (A-Trait). The STAI-Y distinguishes between a general proneness to anxious behavior rooted in the personality and anxiety as a fleeting emotional state. The instrument consists of two 20-item scales. In the current study, the measure will be used to measure trait and state anxiety. The STAI is the validated instrument for measuring anxiety in working adults, and in young adults in high school and college.

Time frame: Approximately 5 minutes to one hour before procedure

Parent Pain Scale

Parents/Caregivers will be asked to report on their child's pain on a faces pain scale of 1 to 6, from least to most pain, during 1) the IV start procedure and 2) the mask induction. (See description of Child Pain - POST)

Time frame: Approximately 5-15 minutes after procedure

7-item self-report measure of healthcare provider's perceptions about the child's cooperation, pain, distress, and anxiety

The healthcare provider survey is a 7-item Likert-like investigator-developed survey to assess their estimates of pain and anxiety management, cooperation, and satisfaction with the procedure. Healthcare providers are also invited to write comments about the use of VR (if applicable) during the IV placement procedure.

Time frame: Peri-procedure

6-item self-report measure of healthcare provider's perceptions about the child's cooperation, distress, and anxiety

The healthcare provider survey is a 6-item Likert-like investigator-developed survey to assess their estimates of fear reduction, decreased behavioral distress, and overall satisfaction related to the procedure they just performed with the child/adolescent. Healthcare providers are also asked about sedative use and are invited to write comments about the use of VR (if applicable) during the mask induction procedure.

Time frame: Peri-procedure

VAS anticipatory anxiety measure

Time frame: Approximately 5-15 minutes after procedure

STAI-C (if elementary or junior high aged), STAI-Y (if in high school or college)

Time frame: Approximately 5-15 minutes after procedure

The Faces Pain Scale (FPS-R)

Time frame: Approximately 5-15 minutes after procedure

Parent Anxiety Scale

Time frame: Approximately 5-15 minutes after procedure

STAI

Time frame: Approximately 5-15 minutes after procedure

Secondary Outcomes

Malaise Scale (MS)

The MS is a six-point scale indicating level of nausea from (1) no symptoms to (6) being sick The MS is completed before and after administration of the VR game to monitor for any signs of nausea. Instructions to the child are as follows: "This is a scale from one to six. One means that you feel fine and no different to how you normally feel. Two means that you feel a little bit different or funny but not sick in the tummy. Three means that you feel a little bit sick and four means that you feel more than a little bit sick but not really sick. Five means that you feel really sick, like you are going to throw up or vomit and six means that you are being sick or vomiting. I'm going to ask you every few minutes how you feel. I want you to tell me which number from one to six best describes how you feel at that time."

Time frame: Approximately 5 minutes to one hour before procedure

Blood pressure and heart rate (BP/ HR)

Blood pressure and heart rate assessed intraoperatively and in the operating room will be ascertained via chart review.

Time frame: Approximately 5 minutes to one hour before procedure

Child Presence Questionnaire

The Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience. This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format. Items assess the child's sense of involvement, realism, and transportation into the experience. Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion.

Time frame: Approximately 5-15 minutes after procedure

Behavior Assessment System for Children (BASC-2)

The BASC-2 is a multi-dimensional approach to evaluate behavior (problem behavior as well as adaptive behavior) of children 8 to 18 years old. The parent-report measure has good internal consistency and test-retest reliability. It has been validated in English and Spanish.

Time frame: Approximately 5 minutes to one hour before procedure

Parent Satisfaction Questionnaire

The parent survey is 16-item, Likert-like survey to assess parent estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction. Two versions of the survey exist, to account for condition (VR vs. standard of care).

Time frame: Approximately 5-15 minutes after procedure

Pediatric Anesthesia Emergence Delirium (Sikich, 2004; PAED)

The PAED rating scale consists of five psychometric items ("child makes eye contact with the caregiver", "child's actions are purposeful", child is aware of the surroundings", child is restless", "child is inconsolable") for the measurement of ED in children. A decreased ability of the child to make eye contact with the caregiver and a declined awareness of his surroundings reflect disturbances in consciousness with a reduced ability to focus, sustain, or shift attention. Less purposeful actions suggest cognitive changes that include perception and memory impairment as well as disorganized thinking patterns. The two other items reflect a disturbance in psychomotor behavior and emotion, although they may also suggest pain or apprehension.

Time frame: Approximately 5-15 minutes after procedure

Watcha Scale (Watcha et al., 1992)

The Watcha Scale is a four point scale that is used to assess emergence delirium (ED). A child with a score of 3 or 4 can be considered to have emergence delirium. The Watcha Scale demonstrates reliability and validity in pediatric populations (Reduque \& Verghese 2012).

Time frame: Approximately 5-15 minutes after procedure

Analgesic Requirements

Frequency and dose of analgesic administered intraoperatively and in the operating room will be ascertained via chart review. Data Obtained: Frequency and dose of analgesic received in the operating room.

Time frame: Peri-procedure

Malaise Scale (MS)

Time frame: Approximately 5-15 minutes after procedure