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临床试验/NCT06010771
NCT06010771已完成不适用

The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Playing Age Children Receiving Palliative Care: A Randomized Controlled Trial

Gamze Akay2 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2023年7月3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
15
试验地点
2
主要终点
FLACC Pain Scale

研究概览

简要总结

The aim of this study is to determine the effect of listening to fairy tales and watching cartoons on pain in the aspiration process in play-age children receiving palliative care.

详细描述

15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly divided into two groups: fairy tale group and cartoon group. Interventions will be applied for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups besides fairy tale or cartoon intervention. The children will be assessed before, during and after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the children will be measured with the help of a bedside monitor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being in the 1-3 age group
  • Being in the palliative care service for at least 3 months
  • Receiving inpatient treatment in the pediatric palliative care service
  • Absence of visual and hearing anomalies
  • No other chronic disease
  • Having a tracheostomy

排除标准

  • The family's desire to leave research.
  • Deterioration of the child's condition
  • The child's diagnosis of an additional chronic disease

结局指标

主要结局

FLACC Pain Scale

时间窗: baseline and up to 4 weeks

FLACC has reliability and validity to determine observational pain of children aged between 3 and 18 years during the medical procedures. This scale is preferred due to its implicity of application among children. It has five categories of behavior to rate pain, namely, facial expression, leg movement, activity, cry, and consolability. The scores of each category are between 0 and 2. The total scores can range from 0 to 10, defined as mild (1-3), moderate (4-6), and severe (7-10). The higher the score, the greater the pain.

Patient Identification Form

时间窗: baseline

In this form, there are questions about the child's age, gender, diagnosis of the disease, length of stay, and how long ago she received the current diagnosis.

Physiological Parameter Record Form

时间窗: baseline and up to 4 weeks

In this form, there are records of all physiological parameters including pulse and respiratory rate, body temperature, blood pressure, SpO2, tidal volume, and peak heart rate. If the value of each parameter is higher than the normal values, it indicates the presence of abnormal condition. Pulse normal value range: 80-130/ Minute Blood pressure normal value range:92-44 mmHg Respiratory rate normal value range: 16-22/ Minute Body temperature normal value range: 36,4-38 degree SpO2 normal value range: %96-98 Tidal volume normal value range: 6-10 ml/kg

次要结局

未报告次要终点

研究者

发起方
Gamze Akay
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gamze Akay

Lecturer

Artvin Coruh University

研究点 (2)

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