Colouring Activity Versus Video Distraction Technique To Alleviate Preoperative Paediatric Patient Anxiety: A Randomised Control Trial
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
Dr Abhishek Nagarajappa
AIIMS New Delhi
