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临床试验/NCT06308991
NCT06308991已完成不适用

The Effect of Yakson and Gentle Touch Method on Pain, Comfort and Physiological Parameters in Preterm Infants During Endotracheal Aspiration

Izmir Democracy University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年7月1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
30
试验地点
2
主要终点
Change in Heart rate

研究概览

简要总结

The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

详细描述

Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.

Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.

Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
26 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
  • Infants undergoing ventilator support with an endotracheal tube

排除标准

  • Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
  • Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
  • Infants who underwent surgery and had a chest tube
  • Infants with intracranial hemorrhage

研究组 & 干预措施

Yakson touch

Experimental

The Yakson method continued for 15 minutes with steady touch (5 minutes), compassionate caressing (5 minutes), and repetition of steady touch (5 minutes). In the Yakson touch method, the palms of the practitioner and all fingers were kept in close contact so that the infants did not feel pressure.

  1. Steady touch (5 minutes): One hand rested on the chest and abdomen of the preterm infant, while the other hand supported the back and hip of the preterm infant.
  2. Compassionate Caress (5 minutes): In the same hand position, the practitioner repeated caressing and resting for 5 minutes: Caress (1 minute), rest (30 seconds), caress (1 minute), rest (30 seconds), and caress (2 minutes). The practitioner caressed the infants' chest and belly with a 1 cm diameter clockwise circular movement every 10 seconds.
  3. Steady touch (5 minutes): The practitioner followed the steady touch procedure as previously described.

干预措施: Yakson touch (Other)

Routine Care

Other

All infants in the control, Yakson, and GHT groups were applied swaddling as the routine practice of the clinic before and during painful procedures.

干预措施: Routine care (Other)

Gentle Human Touch

Experimental

While the practitioner placed one hand on the crown of the preterm infant on the eyebrow line with the fingertip touch for 15 minutes, the other hand was placed on the lower abdomen covering the waist and hip of the infant.

干预措施: Gentle Human Touch (Other)

结局指标

主要结局

Change in Heart rate

时间窗: Heart rate was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.

Heart rate of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.

Neonatal Pain Agitation and Sedation Scale (N-PASS)

时间窗: Pain was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.

Pain will be evaluated using the Neonatal Pain Agitation and Sedation Scale (N-PASS).This scale was developed by Hummel Puchalski in 2000 for preterm and term babies. The Turkish validity and reliability study was conducted by Açıkgöz et al. in 2017. Crying, irritability, behavior-state, facial expression, extremity tone, and vital signs parameters are evaluated in the N-PASS scale. In this scale is evaluated with triple likert type and pain score can be between "0" and "10". Permission was obtained from the authors to use the scale.

Change in Oxygen saturation

时间窗: Oxygen saturation was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.

Oxygen saturation of infants before, during, and after endotracheal aspiration were recorded to a computer using a Masimo Radical 7 Pulse Oximeter at 2-second intervals.

次要结局

  • COMFORTneo Scale(Comfort was assessed 1 minute before endotracheal aspiration, during endotracheal aspiration and 5 minutes after the endotracheal aspiration procedure.)

研究者

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

Sadiye Dur

Assistant Professor

Izmir Democracy University

研究点 (2)

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