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临床试验/NCT04271553
NCT04271553已完成不适用

"Prepare for Operation" Bundle for Young Children Undergoing Elective Surgery: Emotional Manifestation and Anxiety

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
2
主要终点
Children's Emotional Manifestation Scale

研究概览

简要总结

A hospital admission and surgical operation commonly triggers great fear and anxiety to young children. This is caused by either lack of knowledge or misconception. Although parent and families are often given the task to prepare the child for the oncoming surgery, they often lack information and skill to accomplish this task. Although numerous measures such as pre-operative play room, parental companion during induction, distraction therapy have been employed in our institution, this remains to be a challenge for care of young surgical patients.

Our study proposes to use a "prepare-for-operation" (PFO) bundle to assist our paediatric patients and their families to prepare for surgery. The PFO bundle consists of an informative cartoon video illustrating sequence of events occurring in admission, anesthesia and surgery. The video is also accompanied by activity sheets to encourage patient and family to engage, participate and learn about all these events. They will be instructed to use this PFO bundle before admission. We believe that through this off-site and cost-effective intervention, the fear of children undergoing surgery will be significantly alleviated. The family will also have better satisfaction on hospitalization experience. If proven feasible and effective, this will be a simple intervention tool that can be made accessible to all KKH pediatric patients.

详细描述

Research Plan: A prospective assessor-blinded randomized controlled which will recruit 130 pediatric surgical patients aged 4-10 years, undergoing elective operation in KKH. Eligible patients will be identified when an operation date has been booked. They will be approached by a research coordinator (RC) who will counsel about the study details, and recruited after consent.

Randomisaiton will be performed. The subjects will be randomised into group A and group B.

Group A will undergo standard workflow for elective surgical admissions.

Group B, in addition to standard workflow, will also receive the PFO bundle which consists of:

A cartoon video of about 6 minutes duration illustrating the events occuring during admission, anaesthesia and surgery. Video will be given out in DVD and/or with a weblink and a QR code for scanning. The weblink is password protected and is only given to participant and their parents randomised into the video group. Instruction will be given to participants and their parents to watch the video 3 days prior to admission

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
Double (Care Provider, Outcomes Assessor)

盲法说明

prospective blinded (assessor) randomized controlled trial

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 4-10 years, male or female
  • No prior surgical experience
  • Able to communicate clearly, navigate simple technical software, be awake and alert
  • Normal development
  • Able to read and communicate in English

排除标准

  • Abnormal development
  • Has had prior surgical experience
  • Is participating in another study

结局指标

主要结局

Children's Emotional Manifestation Scale

时间窗: 1 day

the behaviour and emotional status of the child will be assessed by a blinded assessor. The score ranges from 5 to 25 where a score of 25 indicates 'uncooperative behaviour' and 5 indicates 'cooperative behaviour'.

Feeling thermometer

时间窗: 1 day

A 5-point likert scale for the child to rate their feeling, where a score of 1 indicates 'very scared' and 5 indicates 'very happy'.

Anxiety score

时间窗: 1 day

Spielberger State-Trait Anxiety Inventory Score for Children (STAIC) which is a validated anxiety score in children, or the Spielberger State-Trait Anxiety Inventory (STAI) Score which is a validated anxiety score in adolescents and adults. This score allows adjustment for the different scores that may be produced for a given situation in individuals who may vary in baseline anxiety levels.

次要结局

  • Induction compliance checklist (ICC)(1 day)
  • Visual analogue scale (VAS)(1 day)
  • Admission feedback questionnaires(1 day)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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