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临床试验/CTRI/2024/06/069289
CTRI/2024/06/069289已完成2/3 期

Effect of immersive virtual reality vs intranasal midazolam on preoperative anxiety in children undergoing inhalation induction of anaesthesia: A prospective, randomised, controlled study

AIIMS, NEW DELHI1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
To compare the effect of immersive virtual reality (IVR) with intranasal midazolam on change in the preoperative anxiety (mYPAS) at inhalational induction of anaesthesia

研究概览

简要总结

Preoperative anxiety is very common in children which can lead issues at induction of anaesthesia and gives a traumatic experience to the child and dissatisfaction among parents.

Various pharmacological and non-pharmacological methods have been used to decrease the preoperative anxiety of the child. Among pharmacological methods, drugs such as midazolam, clonidine, and dexmedetomidine have been used via various routes. However, sedatives drugs may lead to some side effects. Non-pharmacological methods are based mostly on distraction tactics. These include merely talking to the child, or use of audio rhymes, cartoon videos etc.

Immersive virtual reality (IVR) is the latest development in technology of such kind and children seem to adapt to it quickly too. Hence we planned this study to evaluate the effect of IVR on decreasing the preoperative anxiety in children in OT with primary aim to compare the effect of immersive virtual reality (IVR) with intranasal midazolam  on change in the preoperative anxiety at inhalational induction of anaesthesia

After pre-anaesthetic check-up a day before surgery, aim and methodology of the study will be informed to parents and children above the age of 6 years and informed consent will be obtained. Child’s anxiety score (mYPAS) (Tp) will be noted. In the same visit, the VR headset will be checked for proper fitting. The child will choose his/her favourite video. On the day of surgery, the child will be randomised into group V or group M. Child’s mYPAS will be noted in the preoperative room. In group V, selected video via  IVR headset will be played in the preoperative room and he/she will be shifted to OT with the headset on and induction of anaesthesia will be done with face mask and inhalational agents while the child is watching the video via headset.In case of group M, 20 minutes prior to shifting to the OT, 0.3 mg/kg midazolam will be spayed into one nostril or divided doses into both nostrils. The child will be transferred to OT on a trolley and induction of anaesthesia will be done, with face mask and inhalational agents. In both groups, a parent or guardian will accompany the child to the OT according to the hospital policy.

The following steps will be common to both the groups. mYPAS scores will be noted a day before in the ward (Tp), before the initiation of intervention(T0), in the preoperative room at 10 minutes after intervention (T1), the time of transport to OT (T2) and during the induction of anaesthesia (T3). Standard ASA monitors will be attached & inhalational induction will be done with incremental increase in sevoflurane concentration in 100% O2, with an appropriately sized face mask. Assessment of Induction compliance checklist (ICC) and Mask acceptance score (MAS) will be done and noted. Insertion of IV cannula will be done once adequate depth of anaesthesia is achieved. Rest of the anaesthesia management including airway management will be at the discretion of the attending anaesthesiologist. Parent’s satisfaction will be assessed after induction of anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA PS: I,II surgery under general anaesthesia.

排除标准

  • 未提供

结局指标

主要结局

To compare the effect of immersive virtual reality (IVR) with intranasal midazolam on change in the preoperative anxiety (mYPAS) at inhalational induction of anaesthesia

时间窗: From 20 minutes before surgery till induction of anaesthesia

次要结局

  • 1)To compare preoperative anxiety during shifting from preoperative room to operation theatre (OT)(2)To compare the mask acceptance between both groups.)

研究者

发起方
AIIMS, NEW DELHI
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Renu Sinha

Department of Anaesthesiology, Pain medicine and Critical care

研究点 (1)

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