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临床试验/NCT05412719
NCT05412719已完成不适用

The Effect Of Finger Pupiling On Pain And Physiological Parameters During Urinary Culture With Urinary Catheter in İnfants

Okan University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021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
80
试验地点
1
主要终点
SPO2 vital signs

研究概览

简要总结

. In this determined, it was carried out to determine the effect of finger puppet play on pain and physiological parameters during urine culture with urinary catheter in infants.

Research Hypotheses and Variables H0: There is no difference between the pain levels of babies who were manipulated with finger puppets during urine culture sampling with urinary catheter compared to babies in the control group.

H1: Babies whose finger puppet is played during urine culture sampling with urinary catheter have low pain levels.

H2: Physiological parameters of babies who are played with finger puppets during urine culture sample collection with urinary catheter are positively affected.

详细描述

The research was designed as a randomizer controlled experimental study to determine the effect of finger puppet manipulation on pain and physiological catheter parameters during urinary culture with urinary catheterization in 2-12 month old infants. This Research was conducted in pediatric emergency department of SBU Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between Feb.2021-Feb.2022. "Infant follow-up form" and "FLAAC pain scale" were used to collect data. The data obtained from the research were analyzed with appropriate statistical tests in the SPSS 22.0 package program.

Research Hypotheses and Variables H0: There is no difference between the pain levels of babies who were manipulated with finger puppets during urine culture sampling with urinary catheter compared to babies in the control group.

H1: Babies whose finger puppet is played during urine culture sampling with urinary catheter have low pain levels.

H2: Physiological parameters of babies who are played with finger puppets during urine culture sample collection with urinary catheter are positively affected.

Dependent Variables: Infants' physiological parameters (Pulse, Blood pressure, Respiration, SpO2) and Infant Follow-up Form, FLACC pain scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • The baby is between 2 and 12 months
  • Suspicion/diagnosis of urinary tract infection being followed
  • The baby/child does not have a vision or hearing problem (sight-hearing screening tests have been completed)
  • Not taking drugs containing analgesics in the last 4 hours before the procedure
  • Parents' willingness to participate in the research
  • It has been determined as the appropriate cognitive level and motor development of infants/children

排除标准

  • Mentally or neurologically handicapped
  • Having a life-threatening illness
  • Babies who failed the procedure, took longer than 3 minutes and needed to be repeated were excluded from the sample

结局指标

主要结局

SPO2 vital signs

时间窗: 5 minutes after urinary catheterization

SPO2 (%) were evaluated

heart rate vital signs

时间窗: 5 minutes after urinary catheterization

heart rate (beats/minute) were evaluated

blood pressure vital signs

时间窗: 5 minutes after urinary catheterization

blood pressure (mmHg) were evaluated

respiratory rate vital signs

时间窗: 5 minutes after urinary catheterization

respiratory rate (beats/minute) were evaluated

pain score

时间窗: 5 minutes after urinary catheterization

It is used for babies and children aged 2 months to 7 years. It consists of five categories that measure the baby's facial expression, leg movements, activity, crying, and comfortability. A total of 0-10 points are obtained in the scale, where each of the categories is scored between 0-2, and the increase in the score indicates that the pain also increases. According to the scoring system made after the observation, the total score is 0: the child is comfortable, calm, comfortable, 1-3: slightly uncomfortable. or mild pain, 4-6: moderate pain, 7-10: significant severe discomfort or significant severe pain, or both.

次要结局

未报告次要终点

研究者

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

Duygu Cicek

duygu çiçek

Okan University

研究点 (1)

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