跳至主要内容
临床试验/NCT06370117
NCT06370117已完成不适用

The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety

Aydin Adnan Menderes University2 个研究点 分布在 2 个国家目标入组 126 人开始时间: 2023年2月1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
126
试验地点
2
主要终点
Wong-Baker Facial Expression Rating Scale

研究概览

简要总结

The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.

H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

详细描述

Design: It is a randomized controlled experimental study. Methods: This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access. The sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). Children were selected into groups by simple randomization method. Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. Introductory Information Form, Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data.

The data was analyzed on SPSS (Version 25, Chicago, IL, USA). The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed. Descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. The conformity of the measurement values to normal distribution was tested with "Shapirow-wilk" analysis. Pearson chi-square test was applied to the dependency relationship of frequency measurement values. One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups. Kruskal Wallis H-Test was used to compare groups that did not show normal distribution. Mann Whitney U test was used in further analysis to determine the difference between two independent groups. Wilcoxon test was used to test the significance of the difference between the scores of two related measurements. P values <0.05 were considered statistically significant.

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
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • being between the ages of 4-12
  • being willing to participate in the study,
  • being accompanied by their parents (mother or father).

排除标准

  • Failure to establish vascular access on the first try

结局指标

主要结局

Wong-Baker Facial Expression Rating Scale

时间窗: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months

Wong-Baker Facial Expression Rating Scale (WB-FRS): It was developed by Wong and Baker in 1981. This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing pain intensity, increasing from zero to five from left to right (0 points = very happy/no pain, 5 points = the most severe pain). The face on the far left has a smiling expression, indicating a pain-free state, while the face on the far right has a crying expression, corresponding to the most severe pain. The child is told to choose the face that best expresses his/her feelings.

次要结局

  • Children's Fear and Anxiety Scale(From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months)

研究者

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

Bircan Kahraman Berberoglu

research asistant

Aydin Adnan Menderes University

研究点 (2)

Loading locations...

相似试验