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临床试验/NCT06598410
NCT06598410已完成不适用

The Effect of Playing Digital Games and Watching Cartoons on Children&Amp;#39;s Pain, Fear, and Anxiety Levels During Suturing in Pediatric Emergency Unit

Tarsus University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
pain level

研究概览

简要总结

The study was planned as a randomized controlled experimental study to determine the effect of playing digital games and watching cartoons on the pain, fear, and anxiety levels of children during suturing in the pediatric emergency unit. The population of the study, which is planned as a randomized controlled experimental study, will consist of children between the ages of 5-10 who apply to the Trauma Unit of the Pediatric Emergency Unit of Tarsus State Hospital and undergo suturing.

As a result of the Power analysis (G*Power 3.1.9.2); effect size = 1.136, 95% confidence interval, 95% power, it was calculated that a total of 66 children, at least 22 in each group, should be included. Considering that there may be dropout and confounding variables in the research process, it was determined as 90 children in total, with 30 children in each group.

Implementation Stage 1: A pool of cartoons that can be watched and digital games that can be played, suitable for the level of the child in the 5-10 age group, will be created by the researchers by taking the opinion of the relevant experts. The created children's cartoon and digital game pool will be sent to experts in the field (child development specialist, child psychiatrist, child nurse).

Stage 2: A pilot study will be conducted with 10 children to evaluate the suitability of data collection forms, digital games and cartoons for children.

Stage 3: The children and family members in the sample group will be informed about how the application will be carried out and about the research, and written permission will be obtained from the family and verbal permission will be obtained from the child.

It will be ensured that the children in all groups will have their parents with them during the procedure.

Stage 4: Children who meet the sample selection criteria will be divided into 3 groups (1st study group, 2nd study group, and 3rd group control group) through a computerized programme.

Stage 5: The data collection form in the research will be applied to the children in the sample group before the procedure.

6th Stage: The pain, fear and anxiety of the children in all groups before the procedure will be evaluated by the child, parent and nurse.

详细描述

Children experience a traumatic process if cuts occur anywhere on their body after an accident. It has been reported that nursing interventions applied during incision suturing relieve the anxiety and fears of the child. Two main ways are defined as pharmacological and non-pharmacological methods in pain and anxiety management. Therefore, standards have not yet been established for their inclusion in daily patient care. Non-pharmacological methods aim to reduce fear, anxiety, and pain and to give children a sense of control. Both physical and cognitive behavioral approaches are necessary to provide a comfortable environment for children. It is also important to use non-pharmacological interventions during medical procedures to reduce the stress experienced by parents. Nurses can apply these methods independently and encourage family members to participate in patient care actively. Visual distractions minimize pain and also allow action to be taken in an emergency. Various games and cartoons allow the child to express their fears, misconceptions, and anxieties in their own way, both verbally and non-verbally, thus helping the child to cope with stressful situations.

The study was planned as a randomized controlled experimental study to determine the effect of playing digital games and watching cartoons on the pain, fear, and anxiety levels of children during suturing in the pediatric emergency unit. The population of the study, which is planned as a randomized controlled experimental study, will consist of children between the ages of 5-10 who apply to the Trauma Unit of the Pediatric Emergency Unit of Tarsus State Hospital and undergo suturing.

While determining the sample size of the study, as the result of the literature review to determine the effect size sample size, Kavlakcı (2020) 'The Effect of Digital Game Playing on Pain, Fear and Anxiety Levels During Suturing in Children: A Randomised Controlled Study' was taken as a basis. As a result of the Power analysis (G*Power 3.1.9.2); effect size = 1.136, 95% confidence interval, 95% power, it was calculated that a total of 66 children, at least 22 in each group, should be included. Considering that there may be dropout and confounding variables in the research process, it was determined as 90 children in total, with 30 children in each group.

The data of the research will be collected using the following data collection tool:

Introductory Information Form: It consists of a total of 15 questions, including sociodemographic characteristics (13) questions and (2) questions about the procedure, prepared in line with the literature.

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
None

入排标准

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

入选标准

  • Between 5-10 years old
  • Suture removal will be applied
  • Number of sutures 3 or more
  • volunteering to participate in the study.

排除标准

  • No previous suturing procedure
  • Suturing to be applied to the hand, arm area
  • The child has visual, hearing and intellectual disabilities
  • Having a physical problem that prevents them from playing digital games

研究组 & 干预措施

Digital Gaming

Experimental

Children will play digital games during suturing in the Paediatric Emergency Unit

干预措施: Digital gaming (Other)

Watching Cartoon

Experimental

Children will watching cartoon during suturing in the Paediatric Emergency Unit

干预措施: watching cartoon (Other)

Control

No Intervention

Children will not be subjected to any form of distraction

结局指标

主要结局

pain level

时间窗: 1 hour

Wong Baker Pain Scale: It was developed by Donna Wong and Connie Morain Baker in 1980 and adapted again in 1983 to measure the pain levels of paediatric patients. There are 6 facial expressions scored between 0-5. In the Wong-Baker Scale, there are facial expressions indicating the degree of pain increasing from 0 to 5 from left to right.

fear

时间窗: 1 hour

Child Fear Scale: The scale was developed by Thurillet et al. It was developed to evaluate children\'s fears based on self-report of children aged 4-12 years. The scale consists of six facial expressions. The scale grades fear with a score ranging from 0 to 10 (gradually graded two by two) consistent with pain rating scales. The first facial expression shows that there is no fear, the fear increases as you go from right to left, and the sixth facial expression shows that the level of fear is the highest. A statistically significant positive and very high correlation was obtained between the Fear Scale and the Child Fear Scale (r=0.973; p;0.001). The high correlation value between the two forms shows that the child form is valid.

anxiety

时间窗: 1 hour

Child Anxiety Scale-Dispositional Scale (CAS-D): It was developed by Ersig et al. (2013) to measure the anxiety levels of children aged 4-10 years. The CAS-D scale is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In this scale for children aged 4-10 years, children are asked 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer' or 'If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are'. In order to measure state anxiety (CAS-D), the child is asked to tick how he/she feels 'right now'. The score can range from 0-10.

次要结局

未报告次要终点

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atiye Karakul

Assoc. Prof.

Tarsus University

研究点 (2)

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