跳至主要内容
临床试验/NCT05801640
NCT05801640已完成不适用

Facilitated Tucking Position and Reiki Efficacy in Orogastric Tube Insertion in Preterm Infants: Randomized Controlled Trial

Sibel Küçükoğlu2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2022年2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
45
试验地点
2
主要终点
Newborn Information Form

研究概览

简要总结

The aim of this study is to determine the effects of faciliated tucking and reiki given manually during orogastric tube insertion in preterm infants treated in the NICU on stress, pain and physiological parameter (heartbeat, blood pressure, SpO2 and respiratory rate) levels.

详细描述

Regardless of the severity and duration, preterm infants give physiological and behavioral responses to a painful application. While infants show behavioral responses such as crying, changes in facial expressions, acceleration or deceleration in motor movements during painful interventions, they may subjectively show changes in physiological parameters such as heart rate, respiratory rate, blood pressure, and decrease in saturation value. Because preterm infants are sensitive to many stress factors and due to reasons such as separation from the mother during the treatment process, environments with excessive light, sound and temperature changes, and the absence of a single caregiver. They do not yet have the physiological maturity to cope with painful interventions. This randomized controlled trial was planned to determine the changes in stress, pain, and physiological parameters of faciliated tucking and reiki administered during orogastric tube insertion in preterm infants 32-37 weeks of gestation.

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
Double (Participant, Outcomes Assessor)

盲法说明

Single (participant and outcomes assessor)

入排标准

年龄范围
32 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • 32-37 Gestational weeks,
  • From the postnatal 3rd day,
  • Feeding with orogastric tube
  • Apgar >5

排除标准

  • Premature infants with congenital anomaly, malformation
  • Premature infants on mechanical ventilator
  • Premature infants receiving sedation

结局指标

主要结局

Newborn Information Form

时间窗: One measurement- Half an hour before the intervention

The descriptive characteristics form was based on a literature review conducted by the researcher (Axelin, Salanterä \& Lehtonen, 2006; Kucukoglu, Kurt \& Aytekin, 2015; Yin, Yang, Lee, Li, Hua \& Liaw, 2015). The form consisted of items on gestational age, postnatal age, gender, birth weight (grams), type of delivery, 1st and 5th minute Apgar score, etc.

Neonatal Stress Scale

时间窗: Second measurement- 1 minute after OG tube insertion

To determine the effect of facilitated tucking position on stress score during OG procedure in preterm infants. It was developed by Ceylan and Bolışık (2017) to evaluate the stress level in premature infants. The scale is suitable for use by nurses. The scale includes 8 subgroups including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities and posture, and consists of a total of 24 items in 3-likert type. In scoring, each subgroup is evaluated between 0-2 points. The score obtained from the scale is a minimum of 0 points and a maximum of 16 points. This form filled by a clinical nurse and researcher 2 times before, and after the procedure.

Physiological Parameter Tracking Chart

时间窗: Second measurement 1 minute after OG tube insertion

It is a form that includes the heart rate, oxygen saturation value and respiratory rate. This form filled by a clinical nurse 2 times before and after the procedure, by a clinical nurse other than the person performing the research.

The premature infant pain profile-revised (PIPP-R)

时间窗: Second measurement 1 minute after OG tube insertion

The PIPP-R scale includes 3 behavioral (fringing, squeezing eyes, nasolobial-groove), 2 physiological (heart rate and oxygen saturation) and 2 contextual (behavioral status and gestational age) items used in the assessment of pain in newborns.This form filled by a clinical nurse and researcher 2 times before, and after the procedure. The PIPP-R is a Likert-type scale. In scoring the scale, items related to physiological and behavioral parameters are scored as 0,1,2,3 for each variable, reflecting the difference between the initial state and the values during the procedure.

次要结局

未报告次要终点

研究者

发起方
Sibel Küçükoğlu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sibel Küçükoğlu

Professor Ph.D.

Selcuk University

研究点 (2)

Loading locations...

相似试验