Comparing the Effectiveness of Virtual Reality in Paediatric Patients

NCT06044753 | Completed DMC

• 1 other identifier: JEP-2020-363
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To the best of our knowledge,the investigators found only a study using VR in reducing preoperative anxiety in paediatric population. Ryu et al found that children who received preoperative VR tour of the operation theatre had perfect score in induction compliance checklist (ICC). With these encouraging data,the investigators decide to conduct a study to determine whether the use of cartoon video VR headset during induction of anaesthesia is able to reduce preoperative anxiety and increase compliance during inhalation induction in children undergoing surgery.

Conditions

Pediatric Population; Preoperative Anxiety

Keywords

Induction of anaesthesia; Preoperative anxiety; Virtual reality; Paediatric patients

Outcome Measures

Primary Outcomes (1)

• Compare Effectiveness of Virtual reality intervention versus standard care in reducing anxiety in paediatric patients undergoing inhalation induction

  Primary objective is to compare effectiveness of virtual reality ( VR) intervention versus standard care in reducing anxiety of paediatric patients undergoing inhalation induction of anaesthesia by using the induction compliance checklist and compare with their mYPAS score. If the mYPAS score is high in Virtual Reality arm, however, Induction Compliance checklist is perfect score, hence we can conclude that VR arm patient have benefitted from the use of VR in reducing preoperative anxiety.

  1 year

Secondary Outcomes (1)

• Secondary objective is to investigate system usability of using virtual reality in inducing paediatric patients.

  1 year

Study Arms (2)

Control Arm( Arm1)

NO INTERVENTION

Arm1 which is standard care/control group (as per usual practice). May use the distraction, Parental presence, or with musics, soft prep talks, distractions with toys, as per anaesthetist's usual practice. Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner

VR ( Virtual Reality) ( Arm2)

EXPERIMENTAL

Group 2 patients will choose one of the three YouTube videos, either Frozen theme song, SpongeBob or Minions according to their preference. The selected video will be played on the doctor's handphone and slotted into the VR headset.A handphone playing YouTube videos (either Frozen or SpongeBob or Minions VR cartoons) will be slotted into the VR headset prior to applying on the patient. They will have mask on first followed by the VR headset. Patients will receive 100% oxygen of 6 L/min flow for 30 seconds. Nitrous oxide of 2 L/min will be added with ratio oxygen and nitrous oxide of 3:1. Sevoflurane inhalation will be initiated with 4% concentration for 30 seconds, followed by 8%. The induction will be proceeded in usual manner

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset DEVICE

Non immersive VR experience basically means providing a near reality environment for viewers, however, viewers won't be able to make any changes to it as they can only watch. This Non-immersive Virtual reality experience will be applied unto the child by using a headset that incorporates a computerized dimensional environment which will be simulated to make the child feel near reality .The VR headset consist of a cover for handphone slot, screen display, two lenses with adjustable eye pieces to focus, foam padding and adjustable elastic head mount strap.

VR ( Virtual Reality) ( Arm2)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) I or II patients.
• Patients between 4-12 years of age.
• Elective and emergency cases

You may not qualify if:

• Maxillofacial anomalies
• Skull anomalies that make fitting mask difficult
• Visual and hearing impairment
• Epilepsy
• Contraindication to nitrous oxide and sevoflurane inhalation induction. For example; malignant hyperthermia, ear surgery and pneumothorax.
• Autism spectrum disorder

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (5)

• Ryu JH, Park SJ, Park JW, Kim JW, Yoo HJ, Kim TW, Hong JS, Han SH. Randomized clinical trial of immersive virtual reality tour of the operating theatre in children before anaesthesia. Br J Surg. 2017 Nov;104(12):1628-1633. doi: 10.1002/bjs.10684. Epub 2017 Oct 4.

  PMID: 28975600 BACKGROUND

• Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.

  PMID: 23051880 BACKGROUND

• Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.

  PMID: 10320165 BACKGROUND

• Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.

  PMID: 24257388 BACKGROUND

• Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.

  PMID: 20691523 BACKGROUND

Study Officials

• Maryam Budiman

  Universiti Kebansaan Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking of parents and patients, until entering the operation theatre
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Paediatric Patients age 4 to 12 .

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: September 21, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

MY (1)