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临床试验/NCT06109298
NCT06109298已完成不适用

The Effect of Cold Spray and Ice Applied During Intravenous Access on Pain and Fear in Children Aged 7-15 Years in Pediatric Emergency Unit

Tarsus University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2021年11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
96
试验地点
2
主要终点
Data Collection Form

研究概览

简要总结

Many strategies have been developed for the prevention of to prevent procedural pain in pediatric emergency units where nurses play a vital role in patient comfort.Easy-to-use and inexpensive nonpharmacologic analgesic methods are important in emergency units.This study was conducted to determine the effect of cold spray and ice applied during venipuncture on the level of fear and pain in children ages 7-15. This randomized, controlled experimental study was conducted in the Pediatric Emergency Clinic of Istanbul Gaziosmanpaşa Training and Research Hospital between November 2021 7 and April 2022. The study was conducted with 96 children between the ages of 7 and 15 (cold spray group, ice group, and control group) who were scheduled to have venous access in the pediatric emergency clinic and met the sampling criteria.

The Pediatric Emergency Clinic consists of 10 beds. Patients with complaints such as fever, vomiting, diarrhea, and seizures comprise the majority of those admitted to the clinic. In the Pediatric Emergency Clinic, intravenous interventions were performed in the injection room.

详细描述

This study aimed to determine the effect of cold spray and ice applied during venipuncture procedures on pain and fear in 67 children ages 7-15 admitted to the pediatric emergency unit.

Materials and Methods Setting This randomized, controlled experimental study was conducted in the Pediatric Emergency Clinic of Istanbul Gaziosmanpaşa Training and Research Hospital between November 2021 7 and April 2022. The Pediatric Emergency Clinic consists of 10 beds. Patients with complaints such as fever, vomiting, diarrhea, and seizures comprise the majority of those admitted to the clinic. In the Pediatric Emergency Clinic, intravenous interventions were performed in the injection room.

Sample The study's population comprised children ages 7-15 treated in the Pediatric Emergency Department of Gaziosmanpaşa Training and Research Hospital. The sample consisted of children undergoing intravenous access in line with the inclusion criteria. According to the power analysis for the sample size in line with the literatüre the power of the sample was calculated with the G*Power 3.1 program. With a Type I error of 0.05 and a test power of 0.80 (α= 0.05, 1-β= 0.80), the minimum sample size was calculated as children (30 children in 83 each group). The study was completed with 96 children, including 32 children in the study and control groups, taking into account the losses that might occur from the sample for any reason during the study period.

Allocation In the study, 96 children in the sample will randomly assigned to the control (n=32), ice (n=32), and spray groups (n=32). Random assignment will ensured by using a computer program to determine the group of children (https://www.randomlists.com/team-generator).

Data Collection Before starting the study, the families of the children were informed of the purpose, plan, duration, and how the data would be used. Written consent was obtained in light of the principle of willingness and voluntariness through the Voluntary Information and Consent Form. Pediatric patients included in the study were divided into three groups: cold spray, ice, and control. Environmental conditions were organized the same way in all three groups, and at least one parent was ensured to stay with each child. The study was conducted with a nurse performing intravenous intervention and a nurse researcher.

研究设计

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

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children included in the study were 7-15 years old
  • volunteered to participate
  • Had no chronic diseases, mental or neurological disabilities, neurodevelopmental impairments, or life threatening conditions (sepsis, shock, respiratory/cardiogenic arrest, etc.).

排除标准

  • Children who had taken any analgesic medication before presentation to the emergency department
  • had undergone multiple attempts for vascular access

结局指标

主要结局

Data Collection Form

时间窗: 1 day

The data collection form was prepared by reviewing the literature on the subject. It consisted of a total of 15 questions, including questions about the child's and family's descriptive characteristics (such as age and gender), the reason for going to the emergency room, and complaints, such as previous emergency room visits

Child Fear Scale

时间窗: 1 day

The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.

Visual Analog Scale

时间窗: 1 day

The VAS is the most frequently used scale in pain studies. In children over 7 years of age, it is frequently used because it is common and easy. The VAS is a pain scale with numbers from 1 to 10, equally spaced on a 10 cm horizontal ruler. Children being assessed are asked to choose a pain value between 1 and 10 on this ruler.

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

Duygu Sonmez Duzkaya

Principal Investigator

Tarsus University

研究点 (2)

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