Clinical trial NCT04268914: Virtual Reality to Reduce Pre-Operative Anxiety
Official title: Effectiveness of Virtual Reality to Reduce Pre-Operative Anxiety
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
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
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: AppliedVR Inc.
First posted: 2020-02-13
Enrollment: 450
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS anticipatory anxiety measure
timeFrame: Approximately 5 minutes to one hour before procedure
measure: STAI-C (if elementary or junior high aged), STAI-Y (if in high school or college)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older
timeFrame: Approximately 5 minutes to one hour before procedure
measure: The Faces Pain Scale (FPS-R)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Child Satisfaction Questionnaire
timeFrame: Approximately 5-15 minutes after procedure
measure: CAMPIS-R
timeFrame: Peri-procedure
measure: Yale Preoperative Anxiety Scale (m-YPAS; Kain et al., 1995; Kain et al., 1997)
timeFrame: Peri-procedure
measure: Parent Anxiety Scale
timeFrame: Approximately 5 minutes to one hour before procedure
measure: STAI
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Parent Pain Scale
timeFrame: Approximately 5-15 minutes after procedure
measure: 7-item self-report measure of healthcare provider's perceptions about the child's cooperation, pain, distress, and anxiety
timeFrame: Peri-procedure
measure: 6-item self-report measure of healthcare provider's perceptions about the child's cooperation, distress, and anxiety
timeFrame: Peri-procedure
measure: VAS anticipatory anxiety measure
timeFrame: Approximately 5-15 minutes after procedure
measure: STAI-C (if elementary or junior high aged), STAI-Y (if in high school or college)
timeFrame: Approximately 5-15 minutes after procedure
measure: The Faces Pain Scale (FPS-R)
timeFrame: Approximately 5-15 minutes after procedure
measure: Parent Anxiety Scale
timeFrame: Approximately 5-15 minutes after procedure
measure: STAI
timeFrame: Approximately 5-15 minutes after procedure
Secondary outcomes:
measure: Malaise Scale (MS)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Blood pressure and heart rate (BP/ HR)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Child Presence Questionnaire
timeFrame: Approximately 5-15 minutes after procedure
measure: Behavior Assessment System for Children (BASC-2)
timeFrame: Approximately 5 minutes to one hour before procedure
measure: Parent Satisfaction Questionnaire
timeFrame: Approximately 5-15 minutes after procedure
measure: Pediatric Anesthesia Emergence Delirium (Sikich, 2004; PAED)
timeFrame: Approximately 5-15 minutes after procedure
measure: Watcha Scale (Watcha et al., 1992)
timeFrame: Approximately 5-15 minutes after procedure
measure: Analgesic Requirements
timeFrame: Peri-procedure
measure: Malaise Scale (MS)
timeFrame: Approximately 5-15 minutes after procedure
Other outcomes:
measure: Demographic Survey
timeFrame: Approximately 5 minutes to one hour before procedure
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jeffrey I Gold, PhD
role: PRINCIPAL_INVESTIGATOR
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