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

Tonsillectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03239743
• Other study ID #: 17-025
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: May 2019

Study information

• Verified date: October 2018
• Source: Valley Anesthesiology Consultants
• Contact: Vanessa Pohl, B.S.
• Phone: 602-933-4482
• Email: vpohl[@]phoenixchildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Device:
• Virtual Reality
Child will wear and interact with virtual reality headset while waiting for surgery.

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

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Valley Anesthesiology Consultants	KindVR, Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. Review. — View Citation

Mosso-Vázquez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Induction Compliance of Anesthesia measured by the induction compliance checklist	Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist.	Baseline
Secondary	Post-Operative Emergence Delirium measured by the PAED scale	Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale.	up to 3 hours post operative
Secondary	Post-Operative Pain	Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care.	up to 3 hours post operative
Secondary	Post-Operative Opioid Use	Measure VR use will reduce opioid use compared to patients receiving standard of care	up to 3 hours post operative