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临床试验/CTRI/2024/12/078502
CTRI/2024/12/078502招募中4 期

Colouring Activity Versus Video Distraction Technique To Alleviate Preoperative Paediatric Patient Anxiety: A Randomised Control Trial

Abhishek Nagarajappa1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
216
试验地点
1
主要终点
To compare preoperative anxiety levels between two groups using the modified Yale Preoperative Anxiety

研究概览

简要总结

Preoperative anxiety affects >75% of paediatric patients, manifesting as fear and distress,

particularly during induction of General Anaesthesia (GA)1

. This anxiety can lead to increased

postoperative pain, emergence delirium, increased analgesic requirements and negative

postoperative behavioural changes such as sleep disturbance, separation anxiety, eating

problems and new-onset enuresis 2,3 Anxiety has long-term adverse effects which may lead to

separation anxiety disorders and healthcare avoidance in the future. Research shows a clear

effect of artistic interventions on self-report4 measures of decrease in stress, anxiety, and mood.

Anaesthesiologists have employed a variety of pharmacological and non-pharmacological

strategies to alleviate anxiety in paediatric patients. Pharmacological interventions include

medications such as midazolam 5, clonidine 6 and dexmedetomidine7. On the other hand, non-

pharmacological approaches encompass therapeutic play8,9

, music therapy10

, clown

intervention11, 12

, hypnosis13

, storytelling14

, head play15

, engaging children in video games 16

,

and interactive activities with play dough17

. Additionally, strategies like pre-operative

information video18

, and web-based tailored intervention19 have been explored. More

innovative techniques, such as smartphones20 and Virtual Reality (VR) tours21 of the operating

theatre, along with video distraction22 methods, have also been studied for their effectiveness

in reducing anxiety in young patients during medical procedures.

Research shows that non-pharmacological methods are superior to pharmacological methods

to alleviate paediatric patient anxiety, and they can be used without the fear of causing any side

effects23

. Midazolam is associated with delayed onset of action associated with adverse effects

such as agitation, restlessness and extended duration of hospitalisation among patients24

. Pre-

operative education empowers children to approach surgery with positive expectations and also

improve the caregiver’s perception of the experience25

.

Colouring activity helps lower anxiety in children through several mechanisms26

. i)

mindfulness and focus: Engaging in colouring allows children to utilise all their senses,

promoting presence in the moment. ii) Structured Creativity: Working with pre-drawn

templates offers a clear structure, which can be less overwhelming than colouring on a blank

page. iii) Relaxation Response: The repetitive nature of colouring provides a calming rhythm

akin to meditation, which aids relaxation and lowers cortisol levels. iv) Emotional Expression:

Colouring enables children to visually express their emotions, facilitating communication

about their feelings and promoting emotional release. These factors make colouring a valuable

tool for managing anxiety in paediatric populations.

Hypothesis: Engaging in colouring activities provides a superior anxiolytic effect in children

due to its soothing properties, prolonged calming effects, and the sense of achievement it

fosters. Additionally, it allows children to express their emotions creatively in a non-verbal

manner, potentially enhancing their emotional well-being. We planned this study to evaluate

the effect of using colouring activities in the Child information sheet in the preoperative period

on decreasing the preoperative anxiety in children in OT

Reference

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研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • 5 to 12 years
  • ASA PS: I, II.

排除标准

  • Mentally subnormal, low visual acuity, profound sensory mutual hearing loss, parent’s or guardian’s refusal, child’s refusal, and conditions affecting hand grip.

结局指标

主要结局

To compare preoperative anxiety levels between two groups using the modified Yale Preoperative Anxiety

时间窗: Baseline, 1 hour

Scale- Short Form (mYPAS-SF) between two-time

时间窗: Baseline, 1 hour

points

时间窗: Baseline, 1 hour

T(1) in the waiting area, before the activity is given

时间窗: Baseline, 1 hour

T(3) during mask induction

时间窗: Baseline, 1 hour

次要结局

  • Difference in mYPAS - SF scale before(intervention t (1) vs t(2) & t(4))

研究者

发起方
Abhishek Nagarajappa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Abhishek Nagarajappa

AIIMS New Delhi

研究点 (1)

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