Comparing the Effectiveness of Virtual Reality in Paediatric Patients
Condition: Pediatric Population; Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Detailed description: 
      Patients will be reviewed prior to surgery, where explanation will be given and consent from
      patient's parents will be obtained. Once the parents consented for the study, patient will be
      recruited. Randomization will be carried out using a computer-generated system randomizing
      patient to two groups, Group 1 which is standard care/control group (as per usual practice)
      whereas Group 2 is VR intervention group. No premedication prescribed to patients.

      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.

      Group 2 patients will be tested for the suitability of mask size and applied together with
      the VR headset, meanwhile the strap for VR headset is adjusted accordingly to patient's head
      circumference and fixed for later use. The patient will choose one of the three YouTube
      videos, either Frozen theme song, SpongeBob or Minions according to their preference. These
      VR cartoon videos are 3-Dimension cartoon which are available to view for free. Frozen is a
      famous Disney cartoon, SpongeBob is an American animated cartoon series whereas Minions is an
      animated comedy film. The selected video will be played on the doctor's handphone and slotted
      into the VR headset. The codes for the VR cartoon videos will be scanned by the
      anaesthesiology trainees' registrars and specialists and downloaded into their handphone. The
      VR cartoon will be shown to the patients for 30 seconds to accustom them to wear the VR.

      On the operation day, patients will enter the operation room as routine, while the primary
      investigator observes the patient and score their anxiety level using modified Yale
      Preoperative Anxiety Scale (mYPAS) upon arrival to operation room. Modified Yale Preoperative
      anxiety scale has been proved to be a reliable assessment tool. The mYPAS is a 22-itemized
      score divided into 5 categories which are activities, vocalization, expressing emotions,
      state of arousal and interaction with family members. Each category was scored from 1 to 4,
      except for vocalization, which scored from 1 to 6. As each category is itemized differently,
      partial weights were calculated and then added to the total score. The total score will be
      calculated post-intubation. The scoring will be done by dividing each item rating by the
      highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), the
      produced values will be summed. Divide by 4 and multiply by 100. mYPAS scores of ≤30 is
      described as non-anxious, and mYPAS score > 30 is described as anxious with the minimum score
      of 23.3 to maximum score of 100.13 Subsequently, the patients will be placed either on the
      operation table or be sited on the parent's lap depending on the patient's cooperation. The
      position of patients during induction is documented. Oxygen saturation probe will be applied
      on them. Baseline heart rate (HR) and SpO2 will be documented. Group 1 patients will receive
      standard care of inhaling gaseous induction through mask. For Group 2, 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 in both groups 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. Non-invasive blood pressure (NIBP) cuff
      and electrocardiogram (ECG) leads will be applied to the patients. BP, HR, SpO2 during
      induction and post-intubation will be recorded.

      Following intubation, the attending anaesthetist will score the induction compliance
      checklist (ICC) which is an observational scale on the patient compliance to inhalational
      induction and mask acceptance. The ICC is a validated checklist and contains 10 negative
      behavioural groupings. The ICC score represents the sum of the groupings checked as present
      during induction; high scores correlate with poor behavioural compliance. A perfect induction
      (no negative behaviours) is scored as 0; the highest possible score is 10. For purposes of
      analysis, ICC scores were stratified into three categories: perfect (ICC = 0), moderate (1-3)
      and poor (≥4).

      Anaesthetist in Group 2 will fill up a System Usability Scale (SUS). This scale was created
      by John Brooke in 1986 and used extensively to test numerous products and services. The SUS
      consists of 10 questions with 5 responses for each question ranging from "strongly agree" to
      "strongly disagree". The calculation of the usability score for SUS is, for each of the odd
      numbered questions, subtract 1 from the score. For each of the even numbered questions,
      subtract their value from 5. The produced values will be summed and multiply by 2.5.
      Questions 1,3,5,7 and 9 are positive whereas questions 2,4,6,8 and 10 are negative. The score
      is graded to five grades, score >80.3 (Grade A/ excellent), 68-80.3 (Grade B/ good), 68
      (Grade C/ okay), 51-68 (Grade D/ poor) and ˂51 (Grade F/ awful).

      In a situation where patient is unable to wear VR headset, the patient will be considered
      dropped off from the study. However, if the patient removes the VR headset or pushes away the
      mask during inhalation, data will still be recruited and considered, hence not a drop out
      case.

      Collected data will be used to measure the association of mYPAS anxiety score with the ICC,
      which will determine the compliancy of patient to mask acceptance during induction. If the VR
      group shows a high mYPAS score yet a perfect or low ICC score compared to standard care
      group, hence the investigators can prove that VR does effectively decrease anxiety in
      paediatrics during inhalational induction.
    

Intervention name(s): Virtual Reality Headset
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paediatric Patients age 4 to 12 .
Masking: Single (Participant)
Primary purpose: Other
Keywords: Induction of anaesthesia; Preoperative anxiety; Virtual reality; Paediatric patients