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临床试验/NCT06793618
NCT06793618已完成不适用

Effectiveness of the Z-Track Technique As a Pain-Reducing Strategy for Neonates During Intramuscular Injection: a Randomized Controlled Trial

University of Baghdad1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2024年11月24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
入组人数
147
试验地点
1
主要终点
Neonatal/ Infant Pain Scale

研究概览

简要总结

A quantitative study, true experimental, posttest-only design has been used for the current study. one intervention (the Z-track technique) and one control group involved in the study. The primary outcome measure is the Neonatal/Infant Pain Scale to be used immediately after intramuscular injections to measure the pain level among neonates.

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 (Outcomes Assessor)

入排标准

年龄范围
5 Minutes 至 2 Hours(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates delivered through cesarean section
  • •Apgar score of 8 or more
  • •Weight between 2500 - 3500 grams
  • •neonates receiving IM injections
  • •Males / females
  • •term neonates between 37th and 42nd week of gestation

排除标准

  • •Congenital anomalies
  • •neonates who received intramuscular injection such as the Hepatitis B vaccine
  • •Low birth weight
  • •Neural tube defects
  • •neonates who are of normal vaginal delivery

研究组 & 干预措施

Z-track technique

Active Comparator

To perform the zeta-track technique: In this method, the neonates are in supine position, the skin is moved and held from the injection site 2 to 3 cm to the side or downward using the non- dominant hand, to ensure that blood vessel wasn't penetrated aspiration on the syringe must perceive the injection and then the medication is to be injected slowly. Researcher assistant that is unaware of the injection method performs the recording of the pain intensity and leakage diameter on the observation form.

干预措施: Z-track technique (Other)

Control group

No Intervention

the neonates receive the intramuscular injection using the conventional method and protocol used in the postnatal ward without any interventions

结局指标

主要结局

Neonatal/ Infant Pain Scale

时间窗: from the process of enrollment at the post-natal ward until the IM injection is administered (usually takes less than 1 hour)

A scale developed specifically for newborn infants. Consists of 6 criterion (Face Expression, cry, Patterns of Breathing, leg and arm movements, Arousal status) Recommended for children less than 1 year old.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haider Jumaa Kareem

Academic Nurse

University of Baghdad

研究点 (1)

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