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临床试验/NCT05546463
NCT05546463已完成不适用

The Effects of Playing Digital Games on Children's Pain, Fear and Anxiety Levels During Suturing: A Randomized Controlled Study

Izmir University of Economics1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年1月16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
84
试验地点
1
主要终点
Pain score

研究概览

简要总结

The aim was to determine the effects of digital game play on children's pain, fear and anxiety levels during suturing.

Data was obtained from 84 children between the ages of 8-17 at the Pediatric Emergency Department between 16 January and 19 March 2020, using the Socio-Demographic and Clinical Characteristics Form, the Wong-Baker Faces Pain Rating Scale (WBFPS), the Visual Analogue Scale (VAS), the Fear of Medical Procedure Scale (FMPS), and the State-Trait Anxiety Inventory for Children (STAI-CH). While the study group (n=42) played digital games during the suturing procedure, the control group (n=42) did not play digital games.

详细描述

This study has the potential to contribute to the literature on the effects of playing digital games on the pain, fear, and anxiety levels that children experience during suturing.

Materials and Methods

Design, setting, and sample size:

The data of the randomized controlled study were collected in the Pediatric Emergency Department (PED) of the Training and Research Hospital between 16 January and 19 March 2020. The population of the study are children between the ages of 8 and 17 who were sutured in the PED. Random sampling method was used for participant selection. The size of the sample was determined by the power analysis of the GPower 3.1.9.4 program as 84 children with 0.05 error, 0.95 confidence interval, and 0.5 effect size.

Participants and randomization:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Having no psychological diagnoses.
  • Having no problems in vision, hearing, or speech.
  • Speaking and understanding Turkish.
  • That the number of sutures is 3 or more.
  • That the suture procedure is performing under local anesthesia.
  • That they assent to participate in the study.

排除标准

  • Refusing to play digital games or stop playing before the process ends.
  • Having a physical problem that prevents playing digital games.
  • Being too agitated to communicate with the child.

结局指标

主要结局

Pain score

时间窗: 2 months

Pain score was determined using "Wong-Baker Faces Pain Rating Scale" and "Visual Analogue Scale". Wong-Baker Faces Pain Rating Scale: The Faces Pain Rating Scale, developed by Wong and Baker, is a hand-drawn scale that includes six facial expressions ranging from smiling to crying, and is recommended for use for children aged 3 years and older. Scoring is defined as 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. Visual Analogue Scale: This is a 100 mm long horizontal line with the words "no pain" and "severe pain" at either end. It is suitable for school-age children. The child is asked to mark the point showing the intensity of pain felt at that moment.

Anxiety score

时间窗: 2 months

Anxiety score was determined using "State-Trait Anxiety Inventory for Children" State-Trait Anxiety Inventory for Children: State-Trait Anxiety Inventory for Children was developed by Spielberger in 1973 to measure the anxiety caused to children in particular situations perceived as a threat. In the trait anxiety scale, the children are asked to evaluate how they "generally" feel, and in the state anxiety scale, how they feel in the situation they are in "at that moment", and indicate one of three options. Possible scores range between 20 and 60. A higher score indicates greater anxiety. The validity and reliability study in Türkiye was conducted by Özusta in 1995 for children aged 9-12. In State-Trait Anxiety Inventory for Children, the Cronbach Alpha coefficient of the state anxiety scale was found .82, and the Cronbach Alpha coefficient of the trait anxiety scale was .81.

Socio-Demographic and Clinical Characteristics

时间窗: 2 months

Socio-Demographic and Clinical Characteristics Form: This form consists of a total of 23 questions eliciting information, including on age, gender, previous digital game playing status, number of suturing, and duration of suturing, created by the researchers in accordance with the literature.

Fear score

时间窗: 2 months

Fear score was determined using "Fear for Medical Procedures Scale". Fear of Medical Procedures Scale: Fear of Medical Procedures Scale was developed by Bloom et al. in 1985 to assess children's fears associated with medical procedures and practices. The scale consists of 29 questions evaluating the fear of medical procedures. The scale consists of 4 sub-dimensions, including operational, personal, environmental, and interpersonal items. In the three-point Likert-type scale, for each question, children are asked to choose one of the expressions "no fear" (1 point), "moderate fear" (2 points), "high fear" (3 points). Scores range between 29 and 87. The validity and reliability study in Türkiye was conducted among children aged 7-14 by Alak in 1993, and the reliability coefficient was found to be .93.

次要结局

未报告次要终点

研究者

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

Tülay YAVAN

Prof

Izmir University of Economics

研究点 (1)

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