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临床试验/NCT06326125
NCT06326125Enrolling By Invitation不适用

Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

Uppsala University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年12月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
160
试验地点
1
主要终点
severity of Pain

研究概览

简要总结

This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

详细描述

Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period.

In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature.

On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

TICK-B

Experimental

active distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure.

干预措施: TICK-B (Behavioral)

TkTx-Cream

Experimental

as Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure.

干预措施: TKTX-Cream (Drug)

TICK-B and TkTx-C

Experimental

Pharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure.

干预措施: TICK-B and TKTX-C (Other)

结局指标

主要结局

severity of Pain

时间窗: baseline, during, and immediately post-procedure.

Severity of pain will be assessed using Wong-Baker FACES Pain Rating Scale, a validated self-reporting tool widely utilized in clinical settings. Participants will be instructed to rate their pain on a scale from 0 (indicating no pain) to 10 (representing the worst imaginable pain). The Wong-Baker FACES Pain Rating Scale will be administered promptly after the completion of the procedure.

次要结局

  • Fear(baseline, during, and immediately post-procedure.)

研究者

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

Sherzad Khudeida Suleman

Principal Investigator

Uppsala University

研究点 (1)

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