跳至主要内容
临床试验/CTRI/2025/07/089946
CTRI/2025/07/089946尚未招募不适用

Effect of a children’s play area in the common pre-operative room on anxiety levels of paediatric 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 140 人开始时间: 2025年7月14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
140
试验地点
1
主要终点
Modified Yale preop anxiety score (MYPAS)

研究概览

简要总结

The peri-operative experience can be quite distressing, more so in paediatric patients. Pre-operative anxiety can have long term psychological effects, and behavioral issues even as adults.  Hospitals taking care of paediatric patients, especially those undergoing surgery, should strive to create a friendlier environment for the child as well as the parents. Numerous interventions have been described to decrease paediatric anxiety including use of audio-visual aids and technology, toys, use of medications as well as alternative therapies such as hypnosis and music therapy. Many organizations which are not dedicated paediatric centers, often have common pre-operative areas for adult and paediatric patients. In such cases, dedicated and focused paediatric centric work flow is often difficult to achieve. This is also affected by financial constraints and allocation of funds. This study is planned as a quality improvement initiative at our institute to create a demarcated paediatric friendly area in the common pre-operative rooms of various OT complexes, with the purpose to investigate the clinical effects on the paediatric patients. This study may be able to generate data, which can guide organizations in improving the perioperative experience of the child as well as the family. The hypothesis is that in the post intervention (paediatric play area) implementation  period anxiety  levels of paediatric surgical patients will be lesser than those before the creation of paediatric play area in the common pre op rooms.

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
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2, undergoing elective surgery whose parents are willing for them to participate in the study.

排除标准

  • Emergency surgery, ASA 3 or more; patients with intellectual or developmental disabilities, and those not accompanied by parents.

结局指标

主要结局

Modified Yale preop anxiety score (MYPAS)

时间窗: Baseline measurement will be taken in the evening prior, and main outcome just before taking into OR/ OT

次要结局

  • Parents satisfaction (Likert scale):(After separation from the child in the pre-operative area, and in the post op care unit (either or both parents).)
  • Requirement of pre-medication(at the time of taking into OT)
  • Post operative pain score: FLACC score/ NRS (as per age) in the PACU(15 mins post PACU arrival)
  • Total opioid requirement intraoperative(End of surgery)
  • Hemodynamic parameters (HR, BP, RR, SPO2)(At preop ward visit, on entry to pre op room, on entry to OT and in 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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