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临床试验/NCT05395208
NCT05395208已完成不适用

The Effect Of Whıte Noıse Therapeutıc Touch On Paın Level And Physıologıcal Parameters In Perıpheral Iv Catheter Interactıon In Premature Infants

Okan University2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年6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
81
试验地点
2
主要终点
Pain Score

研究概览

简要总结

Newborns hospitalized with some respiratory problems in the clinic are taken to noninvasive mechanical ventilation support and vascular access is required for some treatments to be applied to these newborns. The presence of nasal cannulas used for noninvasive mechanical ventilation support in newborns causes restlessness, agitation and stress in infants. The uneasiness and stress experienced by babies during vascular access also affects effective vascular access, causing other doses to be delayed or skipped due to treatment doses that are not completed on time. In addition, the pain experienced by babies indirectly affects nurses. It has been reported in many studies that it is effective in reducing the pain experienced by newborns with non-pharmacological methods. Simultaneous white noise will be played and therapeutic touch applied to help touch methods and white noise listening help reduce or control newborns' pain. Many studies have shown that touching to and listening white noise is effective in reducing pain. This study was planned as a randomized controlled experimental study to determine the effect of white noise-accompanied therapeutic touch application on pain level and physiological parameters and noninvasive mechanical ventilation support during peripheral intravenous catheterization in premature infants hospitalized for treatment.

Hypothesis 0: The application of therapeutic touch with white noise during peripheral intravenous catheter intervention in premature infants has no effect on the level of pain.

Hypothesis 1: White noise-accompanied therapeutic touch application reduces pain level during peripheral intravenous catheter intervention in premature infants.

Hypothesis 2: The therapeutic touch application accompanied by white noise during peripheral intravenous catheter intervention in premature infants positively affects physiological parameters.

详细描述

Purpose of the research The study was planned as a randomized controlled experimental study to determine the effect of white noise and therapeutic touch on pain level and physiological parameters and noninvasive mechanical ventilation support during peripheral intravenous catheter intervention in hospitalized premature infants.

As a data collection tool; "Baby Follow-up Form" was used in which some descriptive features of the baby and NIPS and physiological parameter measurements were evaluated.

Application:

The data of the study were collected using simple random sampling method. The newborns to be included in the study were divided into two groups as the intervention group and the control group. The data were determined according to the odd and even numbered days of the calendar between the research dates, and the babies born on the odd numbered days of the calendar were included in the white noise therapeutic touch group (intervention group), and the babies born on the even numbered days of the calendar were included in the control group. The environmental conditions in the two groups were regulated in the same way. The application was carried out with a research nurse performing therapeutic touch, an observer nurse and a practitioner nurse.

Intervention Group (n=40) :

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
32 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • To be in noninvasive mechanical ventilation support,
  • Newborns between 32-36 weeks,
  • Not having a life-threatening disease,
  • No congenital anomalies,
  • Appropriate cognitive level and motor development of the newborn,
  • The newborn does not have a physical problem,
  • Parents' willingness to participate in the research,

排除标准

  • Presence of IV catheter,
  • Having a condition that prevents vascular access,
  • Those who have circulation problems in the body,
  • Using narcotic, sedative opioid and anticonvulsant drugs
  • Pharmacological intervention application for the baby's pain during the procedure

结局指标

主要结局

Pain Score

时间窗: 5 minutes after intravenous catheterization

NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

次要结局

  • Oxygen saturation Vital Signs(5 minutes after intravenous catheterization)
  • Heart rate Vital Signs(5 minutes after intravenous catheterization)
  • Blood pressure Vital Signs(5 minutes after intravenous catheterization)
  • Respiratory Rate Vital Signs(5 minutes after intravenous catheterization)
  • Body temperature Vital Signs(5 minutes after intravenous catheterization)

研究者

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

Zeynep Uysal

NURSE

Okan University

研究点 (2)

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