A randomized controlled trial on non-pharmacological techniques of reducing anxiety among children undergoing elective surgeries
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- modified Yale Preoperative Anxiety score reduction from baseline, to post intervention
研究概览
简要总结
Perioperative anxiety in children undergoing surgeries, is found to be associated with multiple clinical and behavioral adverse outcomes- increased analgesic requirements, emergence delirium(ED), sleep disturbances, enuresis. The use of sedative premedication, however should not be considered as the first and only method to allay their anxiety, as none of the pharmacological agents used for this purpose is found to be ideal or free from adverse effects. Moreover, administering such drugs mandates availability of monitoring and resuscitative equipments, as well as adequate fasting periods. In the light of the wide range of non-pharmacological methods available to reduce anxiety in children, it is imperative that paediatric anaesthesiologists utilize these techniques wherever possible and make the entire experience of undergoing anaesthesia and surgery more comfortable and physiological for them.
However, due to the already established efficacy of the pharmacological premedications, there exists some hesitation with the use of non-pharmacological interventions, and the efficacy of these techniques are only recently being studied. To the best of our knowledge, there is scarcity of literature comparing multiple such techniques, and hence, comparing their efficacy may give us direction and more clarity on their future use and implementation on regular basis.
We compare the efficacy of two non- pharmacological anxiolysis techniques to allay anxiety among (5-14) year old children undergoing elective surgeries with respect to a control group, where verbal preparation was used by the anaesthetists at their own discretion. The groups compared were:
-
Individual cartoon video (Test- group V)
-
Guided tour of operation theatre using VR headset(Test- group VR)
-
Verbal preparation at the discretion of the anaesthetist during PAE and in OT (Control- group C)
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 14.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade: I, II
- •Patients who are scheduled for any elective diagnostic or therapeutic surgical procedure
- •Patients whose parent/ LAR are willing to give written consent.
排除标准
- •1.Patient refusal at any stage, even after parent/LAR have given consent
- •ASA grade III/ IV/V
- •Patients who are expected to be sedated/ mechanically ventilated or shifted to ICU after surgery
- •Patients who have undergone surgery/or anaesthesia in the past
- •Any psychological/ behavioral disorder, those on psychoactive medications, those with history of epilepsy or seizure
- •Blind, deaf and mute patients.
结局指标
主要结局
modified Yale Preoperative Anxiety score reduction from baseline, to post intervention
时间窗: Baseline- in the preanaesthesia room, Post intervention- immediately after shifting inside OR before induction of anaesthesia; and third reading- immediately after recovery in the recovery room
次要结局
- Studying the acceptance rate of the different anxiolysis techniques among the study participants(Baseline- only once while introducing the intervention first time, to each patient)
研究者
Sreyashi Naskar
Indira Gandhi Institute of Child Health, Bangalore