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临床试验/NCT06436391
NCT06436391已完成不适用

Effect of Kinesio Tape and ShotBlocker on Pain, Comfort and Crying Duration in Heel Blood Collection in Infants: Randomized Controlled Trial

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年6月10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
发起方
入组人数
72
试验地点
1
主要终点
Determining the descriptive characteristics of infants

研究概览

简要总结

This study aims to evaluate the effectiveness of 2 non-pharmacological methods that will reduce the traumatizing effect of routine heel pricking in infant babies within the scope of the metabolic endocrine screening program. One of the interventions to be used in the study is kinesio taping, a type of taping that does not contain any medication. Another intervention is Shotblocker, which does not belong to any drug or device group.

详细描述

Studies on pain indicate that severe pain experienced in the early period of life causes a weakening of the cognitive functions of the infant, especially by shrinking the thalamic volume. Pain management in the neonatal period aims to help the infant cope with pain by relieving it. For effective pain management, it is very important to diagnose and evaluate the baby's response to pain early and accurately within a multidisciplinary team approach, and to select appropriate interventions to alleviate the pain experience. It is stated that nonpharmacological methods in relieving procedural pain strengthen the baby's natural regulation and coping mechanisms when faced with painful intervention and reduce pain and stress. For this reason, this study aimed to determine the effect of kinesiology taping and ShotBlocker applied to the heel during heel blood collection in infant babies on pain, comfort and crying time.

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)

盲法说明

Single Blinded for mothers

入排标准

年龄范围
38 Weeks 至 41 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Term birth infants,
  • •Infants with a birth weight of 2500 g and above
  • •Infants with stable clinical condition
  • •Infants who can perform vital functions without support,
  • •Infants who were fed, calm and not crying within one hour before the procedure will be included.

排除标准

  • •With a genetic or congenital anomaly,
  • •Neurological, cardiological and metabolic diseases,
  • •In need of respiratory support,
  • •Infants receiving analgesics, antiepileptics before the procedure will be excluded.

研究组 & 干预措施

Kinesio tape group

Experimental

To the infants in the experimental group; Kinesio tape application will be performed by an experienced physiotherapist whom has a M.Sc. degree and kinesio tape certificate.

干预措施: Kinesio taping (Other)

ShotBlocker group

Experimental

To the infants in the second experimental group; Shotblocker application will be performed by another researcher.

干预措施: ShotBlocker (Other)

Control group

No Intervention

These infants will not receive any intervention in the heel prick procedure. Routine heel blood collection will be performed.

结局指标

主要结局

Determining the descriptive characteristics of infants

时间窗: Average 5 minutes

1-Infant Introduction Form The questionnaire created by the researchers consisted of a total of 10 questions including infant gender, gestational age, postnatal age, birth weight and some demographic characteristics.

Follow-up of infants

时间窗: Average 5 minutes

2- Infant Follow-up Form: This form is the form to record the duration of the procedure and the duration of crying.

The effect of Kinesio tape and ShotBlocker on pain

时间窗: Average 5 minutes

3- Neonatal Infant Pain Scale (NIPS):This scale, which was developed in 1993 to evaluate behavioral and physiological pain responses of preterm and term infants, was adapted into Turkish in 1999. A high score indicates that the severity of pain.

次要结局

  • The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .(Average 5 minutes)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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