跳至主要内容
临床试验/CTRI/2025/07/091467
CTRI/2025/07/091467尚未招募不适用

Effect of exposure to a paediatric play area in the common pre-operative room on anxiety levels of adult patients undergoing elective surgery: a quasi-experimental study

Dr Mridul Dhar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
The Amsterdam preoperative anxiety and information

研究概览

简要总结

Pre-operative anxiety is a natural and expected reaction in patients who are scheduled to undergo surgery. Although well described in literature, this aspect is often undiagnosed and undetected, with anxiolysis interventions only in those who manifest extreme symptoms, or those who express anxiety overtly to the physicians. Pre operative anxiety in adult patients has been found to be as high as 52%. Pharmacological and non-pharmacological techniques have been described in literature to decrease anxiety. At various institutes such as ours, there is a common adult and paediatric pre-operative holding area of the operation theatre. This offers a unique opportunity to set up a demarcated paediatric play area in this common area, where paediatric patients can play and interact with other paediatric patients. We intend to analyse the effect of this play area on adult patient’s anxiety levels, with the hypothesis that after implementing this quality improvement intervention the anxiety levels will be lower than pre intervention group of patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All consenting adult patients aged 18-70 years of age, of both genders, ASA 1-3, undergoing elective surgery.

排除标准

  • Emergency surgery, ASA 4 or more; patients with intellectual or developmental disabilities or neurological impairment of any kind.

结局指标

主要结局

The Amsterdam preoperative anxiety and information

时间窗: Baseline measurement will be taken in the evening prior, during pre-op visit. Main outcome measured just before taking into the OT

Scale (APAIS) (4-20)

时间窗: Baseline measurement will be taken in the evening prior, during pre-op visit. Main outcome measured just before taking into the OT

次要结局

  • Requirement of anxiolysis medication (intravenous)(At time of induction)
  • Post operative pain score: Numerical rating scale(After arrival in the PACU)
  • Total opioid requirement intraoperative(End of surgery)
  • Haemodynamic parameters (HR, BP, RR)(At preop visit, on entry to pre op room, on entry to OT and in post op care unit (PACU).)
  • Peri-operative satisfaction (Likert scale 1-5)(In the PACU)

研究者

发起方
Dr Mridul Dhar
申办方类型
Other [pi]
责任方
Principal Investigator
主要研究者

Mridul Dhar

AIIMS Rishikesh

研究点 (1)

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