Virtual Reality to Reduce Pre-Operative Anxiety

NCT04268914 | Suspended FDA Device

• 1 other identifier: CHLA-15-00461
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

virtual reality; augmented reality; IV stick; mask induction; tonsillectomy; adenoidectomy; arthroscopy; hernia; circumcision; orchiopexy; hymenectomy; esophagogastroduodenoscopy; colonoscopy; tymanoplasty; myringotomy; pilondial cyst excision; pain; anxiety

Outcome Measures

Primary Outcomes (17)

• 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.

  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.

  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.

  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.

  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).

  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).

  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.

  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)

  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.

  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)

  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.

  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.

  Peri-procedure

• 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.

  Approximately 5-15 minutes after 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.

  Approximately 5-15 minutes after 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.

  Approximately 5-15 minutes after 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)

  Approximately 5-15 minutes after 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.

  Approximately 5-15 minutes after procedure

Secondary Outcomes (9)

• Malaise Scale (MS)

  Approximately 5 minutes to one hour before procedure

• Blood pressure and heart rate (BP/ HR)

  Approximately 5 minutes to one hour before procedure

• Child Presence Questionnaire

  Approximately 5-15 minutes after procedure

• Behavior Assessment System for Children (BASC-2)

  Approximately 5 minutes to one hour before procedure

• Parent Satisfaction Questionnaire

  Approximately 5-15 minutes after procedure

Other Outcomes (1)

• Demographic Survey

  Approximately 5 minutes to one hour before procedure

Study Arms (2)

Standard of Care (No VR) Randomization

NO INTERVENTION

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

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.

Device: Oculus Go VR; Device: Mira Prism VR

Interventions

Oculus Go VR DEVICE

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.

VR Randomization

Mira Prism VR DEVICE

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.

VR Randomization

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• AppliedVR Inc.: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Pain; Anxiety Disorders; Hernia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathological Conditions, Anatomical

Study Officials

• Jeffrey I Gold, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Pediatrics, and Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: December 4, 2015
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 6, 2026
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)