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Effects of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in Children and Adolescents

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ClinicalTrials.gov Identifier: NCT03239743
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
KindVR
Phoenix Children's Hospital
Information provided by (Responsible Party):
Neil Raj Singhal, Valley Anesthesiology Consultants

Brief Summary:

Pain and anxiety have a direct correlation. Patients who experience anxiety are more susceptible to feeling pain, and patients who experience pain are more likely to have a component of anxiety associated with their pain. A common technique used by pain psychologists to help minimize pain is distraction. Different forms of distraction include video games, movies, music, etc. Recently, doctors and researchers around the world have begun experimenting with Virtual Reality as a distraction technique.

A review of the use of virtual reality compared to the current standard of care may help uncover important trends regarding anxiety, postoperative pain and analgesic use in patients who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.


Condition or disease Intervention/treatment Phase
Tonsillectomy Device: Virtual Reality Drug: Midazolam Not Applicable

Detailed Description:

There are approximately five million pediatric surgeries performed in the United States every year, and approximately 50% of pediatric patients experience significant stress and anxiety before their surgery. High anxiety can result in increased postoperative pain, increased analgesic consumption, and delayed recovery. The perception of pain can have a strong psychological component and can increase if the patient gives the area of injury constant attention. Thus, different distraction techniques have been utilized by pain psychologists to take the patient's attention away from the area of injury.

Pharmacological intervention to treat preoperative anxiety in children has its own side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to alleviate preoperative anxiety. However, there are many side-effects that are not always preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been documented, and delayed emergence is possible in surgeries of short duration. In addition, midazolam can also result in critical events perioperatively, such as airway obstruction and worsened nausea and vomiting. Non-pharmacological interventions could help avoid these complications, however, current studies do not show a viable alternative to a pharmacological interventions.

Virtual Reality (VR) is a technology that allows individuals to experience a virtual world. VR initially began as a form of entertainment, but it has expanded its application into several other areas. Within the past 10 years, this type of technology has been applied clinically as a method of distraction for medical procedures such as chemotherapy, physical therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an interactive world stimulating sights, sounds, and motion to help enhance the distraction from pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual Reality Medical Center to test the usability and safety in patients with chronic pain. Patients were presented with pleasant relaxing scenes including natural areas like forests, beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing. Researchers in this study found that the pain distraction virtual environment (VE) was easy to use, had good stereo sound effects, and was immersive and interactive. They also found that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using the VR device. No studies have involved VR in setting of anesthesia induction period and a non-pharmacological intervention for preoperative anxiety.

A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a head-mounted VR device. All six study participants reported a significant drop in pain while using the natural VE. Similarly, a study from the University of Washington found that children playing VR video games or navigating through a virtual environment while receiving wound care for their burns had lower pain scores than patients who just played video games. Another study conducted by Wiederhold et al., looked at fear and pain before and after dental treatment and found a significant decrease in pain perception and stated anxiety scores in patients using the VR eyeglasses compared to the nonuse group.

Based on success in other medical procedures, we propose a study to examine the efficacy and feasibility of using VR during induction of anesthesia to help minimize anxiety, postoperative pain and analgesic use in patients undergoing a tonsillectomy or a tonsillectomy and adenoidectomy procedure.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Tonsillitis

Arm Intervention/treatment
Experimental: Virtual Reality Group
Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication.
Device: Virtual Reality
Child will wear and interact with virtual reality headset while waiting for surgery.
Other Name: KindVR

Active Comparator: Midazolam Group
Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety.
Drug: Midazolam
Child will receive Midazolam to help with pre-operative anxiety prior to surgery
Other Name: Versed




Primary Outcome Measures :
  1. Pre-Operative Anxiety measured by mYPAS anxiety scores [ Time Frame: Baseline ]
    Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period


Secondary Outcome Measures :
  1. Induction Compliance of Anesthesia measured by the induction compliance checklist [ Time Frame: Baseline ]
    Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist.

  2. Post-Operative Emergence Delirium measured by the PAED scale [ Time Frame: up to 3 hours post operative ]
    Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale.

  3. Post-Operative Pain [ Time Frame: up to 3 hours post operative ]
    Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care.

  4. Post-Operative Opioid Use [ Time Frame: up to 3 hours post operative ]
    Measure VR use will reduce opioid use compared to patients receiving standard of care



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient undergoing tonsillectomy or tonsillectomy and adenoidectomy procedure
  • Must be between the ages of 5 and 11 years
  • Anxious/moderate anxiety patients (mYPAS greater than or equal to 30)

Exclusion Criteria:

  • Any patient with preoperative peripherally placed IV
  • Any patient who is cognitively impaired
  • Any patient with a previous surgery
  • ASA Physical Status higher than II
  • Body Mass Index >30
  • A history of affective disorder, attention disorder, or psychotropic medication use
  • Calm/low anxiety patients (mYPAS less than 30)
  • Deaf or blind

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239743


Contacts
Contact: Vanessa Pohl, B.S. 602-933-4482 vpohl@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Raj Singhal, M.D.    602-933-4482    rsinghal@valley.md   
Contact: Vanessa Pohl, B.S.    6029334482    vpohl@phoenixchildrens.com   
Sponsors and Collaborators
Valley Anesthesiology Consultants
KindVR
Phoenix Children's Hospital

Publications:

Responsible Party: Neil Raj Singhal, Pain Management Research Director, Valley Anesthesiology Consultants
ClinicalTrials.gov Identifier: NCT03239743     History of Changes
Other Study ID Numbers: 17-025
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neil Raj Singhal, Valley Anesthesiology Consultants:
virtual reality
adenoidectomy
induction of anesthesia
pre-operative anxiety

Additional relevant MeSH terms:
Anesthetics
Midazolam
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action