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临床试验/NCT04983303
NCT04983303Unknown不适用

Comparing The Effectiveness of Tracing Image and Coloring for Kids-Book With Two Active Distractions on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial

University of Witten/Herdecke0 个研究点目标入组 150 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain

研究概览

简要总结

Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients.

No randomized studies have compared the effectiveness of balloon inflation, cough trick, and TICK-B on reducing pain in children between 6 and 12 years old during the drawing of venous blood samples. The research hypothesis was that children who draw and color a picture, inflate a balloon, or perform the cough trick while having their blood taken would experience less pain and anxiety than children who did not undergo a pain-reducing intervention.

Objectives:

To evaluate the roles of the TICK-B, balloon inflation, and cough trick in relieving pain and fear of school-age children during venipuncture.

To compare the effect of TICK-B with the effects of the cough trick, balloon inflation, on reducing pain and anxiety during venipuncture in children.

To compare the effects of three distraction groups with the control group in relieving pain and anxiety during venipuncture.

详细描述

Venipuncture, a frequently performed needle-related procedure, is one of the foremost frightening experiences, and a typical source of moderate to severe pain for pediatric patients. Approximately 83% of young children aged 2.5-6 years, 51% of youngsters aged 7-12 years, and 28% of adolescents (aged more than 12 years) who underwent venipuncture stated high levels of distress during the painful procedure. However, < 10% of venipuncture performing are given pain management.

To relieve pain, fear, and anxiety in children undergoing venipuncture or venous cannulation, both pharmacological and non-pharmacological approaches are used to help control pediatric patients' discomfort. Pain management includes pharmacologic and non-pharmacologic approaches. The most commonly used pharmacological approach to decrease medical procedure-related pain is the application of topical anesthetic creams. Non-pharmacological methods include distraction actions like blowing bubbles, reading, or playing a game.

Balloon inflation causes a reduction in venous return with increased intrathoracic pressure. It has been speculated that this increase in pressure induces baroreceptor activation with contraction of the pulmonary vessels and that the activation of cardiopulmonary and sinoaortic baroreceptor reflex arcs has an antinociceptive effect, resulting in pain relief.

Coughing increases intrathoracic pressure and stimulation to the autonomic nervous system, causing an increase in heart rate and blood pressure, a higher level of pressure in the subarachnoid space, and baroreceptor activation. The increase in pressure in the subarachnoid space activates the segmental pain inhibiting pathways; thus, the increase in blood pressure and baroreceptor activation appears to be efficacious in reducing the perception of pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, 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

  • School-aged 6-12 years old.
  • Children who require venipuncture.

排除标准

  • Respiratory chronic diseases,
  • Physical impairment,
  • Disability contributing to difficult communication,
  • Children of unsatisfied parents,
  • Children with neurodevelopment delay,
  • Cognitive impairment, hearing impairment or a visual impairment,
  • Taking an analgesic within 6 hours, or for those with a syncope history.

结局指标

主要结局

Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain

时间窗: 5 minutes before procedure done.

To assess the intensity of pain related to the venipuncture procedure in children. Children will self-report their pain severity using the Faces Pain Scale-Revised, which has been validated and shown to be reliable.

Fear

时间窗: 5 minutes before venipuncture procedure done

To assess the fear level of the children related to the venipuncture procedure. Children will self-report their level of fear using the Children's Fear Scale (CFS), which has been validated and shown to be reliable.

次要结局

  • Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain.(1-2 minute after venipuncture procedure done.)
  • Children's Fear Scale (CFS): Fear (0-4) no anxiety to extreme anxiety(1-2 minute after venipuncture procedure done.)
  • Faces Pain Scale-Revised to rate the severity of Pain (0-10) from no pain to worst pain(0 minute during venipuncture procedure (time during insertion of cannula).)

研究者

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

Sherzad Khudeida Suleman

Principal Investigator

University of Witten/Herdecke

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