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临床试验/NCT06044753
NCT06044753已完成不适用

Comparing the Effectiveness of Virtual Reality Versus Control Group in Reducing Preoperative Anxiety in Pediatric Patients

Universiti Kebangsaan Malaysia Medical Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Compare Effectiveness of Virtual reality intervention versus standard care in reducing anxiety in paediatric patients undergoing inhalation induction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Masking of parents and patients, until entering the operation theatre

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Virtual Reality Headset (Device)

结局指标

主要结局

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

时间窗: 1 year

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.

次要结局

  • Secondary objective is to investigate system usability of using virtual reality in inducing paediatric patients.(1 year)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maryam Budiman

Doctor

Universiti Kebangsaan Malaysia Medical Centre

研究点 (1)

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