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

NCT03239743 | Unknown

• 1 other identifier: 17-025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy

Keywords

virtual reality; adenoidectomy; induction of anesthesia; pre-operative anxiety

Outcome Measures

Primary Outcomes (1)

• Pre-Operative Anxiety measured by mYPAS anxiety scores

  Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period

  Baseline

Secondary Outcomes (4)

• Induction Compliance of Anesthesia measured by the induction compliance checklist

  Baseline

• Post-Operative Emergence Delirium measured by the PAED scale

  up to 3 hours post operative

• Post-Operative Pain

  up to 3 hours post operative

• Post-Operative Opioid Use

  up to 3 hours post operative

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication.

Device: Virtual Reality

Midazolam Group

ACTIVE COMPARATOR

Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety.

Drug: Midazolam

Interventions

Virtual Reality DEVICE

Child will wear and interact with virtual reality headset while waiting for surgery.

Also known as: KindVR

Virtual Reality Group

Midazolam DRUG

Child will receive Midazolam to help with pre-operative anxiety prior to surgery

Also known as: Versed

Midazolam Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Valley Anesthesiology Consultants: lead
• KindVR: collaborator
• Phoenix Children's Hospital: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Related Publications (8)

• Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.

  PMID: 19272275 BACKGROUND

• Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.

  PMID: 24892196 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.

  PMID: 24892198 BACKGROUND

• Mosso-Vazquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371-8. doi: 10.1089/cyber.2014.0198.

  PMID: 24892200 BACKGROUND

• Wiederhold BK, Soomro A, Riva G, Wiederhold MD. Future directions: advances and implications of virtual environments designed for pain management. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):414-22. doi: 10.1089/cyber.2014.0197.

  PMID: 24892206 BACKGROUND

• Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7.

  PMID: 21264690 BACKGROUND

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Vanessa Pohl, B.S.

CONTACT

602-933-4482; vpohl@phoenixchildrens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Management Research Director

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: August 4, 2017
• Study Start: July 20, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)