Comparing the Effectiveness of Virtual Reality in Paediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy

NCT03578393

Anxiety Virtual Reality

COMPLETED NA

VR for Preoperative Anxiety in Children

NCT03201640

Anxiety

COMPLETED NA

Effect of Virtual Tour of the Operating Theater on Fear and Anxiety of Preoperative Children

NCT05401539

Preoperative Anxiety

UNKNOWN NA

Effects of Virtual Reality on Perioperative Pediatric Anxiety

NCT04043663

Preoperative Anxiety Maladaptive Postoperative Behavior Emergence Delirium

UNKNOWN NA

Pediatric Preoperative Virtual Reality Program

NCT03957525

Surgery Anxiety

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Population Preoperative Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Paediatric Patients age 4 to 12 .

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Masking of parents and patients, until entering the operation theatre

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VR ( Virtual Reality) ( Arm2)

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

Group Type EXPERIMENTAL

Virtual Reality Headset

Intervention Type 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.

Control Arm( Arm1)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Headset

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes