Effects of Swaddling and Facilitated Tucking on Newborn Pain, Stress and Comfort Levels During Nasal CPAP Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- ALPS Neo Neonatal Pain and Stress Assessment Scale:
研究概览
简要总结
This study was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. The study will be conducted in the neonatal intensive care unit of a Training and Research Hospital between May 2026 and December 2026. Newborns who meet the study criteria from the specified universe will constitute the sample of the study. "Newborn Identification Information Form", "ALPS Neo Neonatal Pain and Stress Assessment Scale", "Premature Baby Comfort Scale" and "Physiological Parameter Follow-up Form" will be used to collect data. will be used.
详细描述
Type of Research: The research will be conducted in a randomized controlled experimental design.
Place and Time of the Research: The research will be conducted in the Neonatal Intensive Care Unit of a Training and Research Hospital between May 2026 and December 2026.
Research Universe and Sample: The universe of this research will consist of newborns receiving nasal CPAP support in the neonatal intensive care units of Recep Tayyip Erdoğan University Training and Research Hospital between May 2026 and December 2026. The newborns from the specified universe who meet the study criteria will constitute the sample of the study. The sample size in the research was calculated using the Gpower program. When the calculation was made with 3 groups (Experiment 1, Experiment 2, Control) and the effect size (d = 0.46), 5% margin of error (α = 0.05) and 99% power (1-β = 0.99), the sample size for each group was found to be 35 people. (Derince, 2016). In case of data loss, it was decided to collect data from a total of 114 newborns (38 fetal position, 38 swaddling, 38 control) by including a 10% spare sample in this number.
Randomization The randomization of the fetal position group, swaddling group and control groups will be determined with the research (https://www.randomizer.org/) program. In addition, after obtaining the ethics committee approval, the research registration number required for randomized controlled studies will be obtained from ClinicalTrials.gov.
Data Collection Tools to be Used in the Study: The Newborn Identification Information Form, ALPS Neo Newborn Pain and Stress Assessment Scale, Premature Baby Comfort Scale and Physiological Parameter Follow-up Form will be used to collect research data. The swaddle blanket used in the neonatal intensive care unit to swaddle babies and the towel support for fetal positioning and the baby care blankets used in the neonatal intensive care unit will be used as intervention tools in the study.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those receiving nasal CPAP support,
- •Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,
- •Those without congenital anomalies,
- •Those without a health problem that prevents positioning,
- •Those without mental or neurological problems.
排除标准
- •Those with pneumothorax,
- •Newborns who received opioids or sedatives 4 hours before the procedure,
- •Intubated newborns
- •Newborns with a gestational age greater than 37 weeks
研究组 & 干预措施
Swaddling group
Newborns in this group will be swaddled during nasal CPAP application.
干预措施: Swaddling (Behavioral)
Facilitated tucking group
Newborns in this group will be placed in the facilitated tucking position during nasal CPAP application.
干预措施: Facilitated tucking (Behavioral)
Control group
newborns in this group will receive standard care.
结局指标
主要结局
ALPS Neo Neonatal Pain and Stress Assessment Scale:
时间窗: 6 month
ALPS Neo Neonatal Pain and Stress Assessment Scale: The "ALPS Neo Neonatal Pain and Stress Assessment Scale" was developed by Lundqvist et al. in 2014, based on the individualized developmental care of the newborn, in order to assess pain and stress in premature and term newborns (Lundqvist et al., 2014). This scale was adapted to Turkish in 2017 and its validity and reliability study was conducted by Ceylan and Bolışık. ALPS Neo is a 3-point Likert-type scale consisting of 5 items, namely "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made through observation. As the scores obtained increase, pain and stress in the newborn increase. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and 5 points and above indicate the presence of severe pain and stress" (Ceylan \& Bolışık, 2017).
Premature Infant Comfort Scale
时间窗: 6 month
The comfort scale, developed by Ambuel and colleagues to measure the pain and stress levels of children aged 0-18, was later adapted by Monique and colleagues in 2007 for premature infants aged ≥28 and ≤37 weeks. The PBCS evaluates 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5 from bad to good. According to the PBCS, the baby's comfort is evaluated based on the total score. Accordingly, 35 indicates the lowest and 7 the highest comfort score. A high score obtained from the scale indicates a low comfort level (Küçük Alemdar and Güdücü Tüfekçi, 2015). The validity and reliability study of the scale was conducted by Alemdar and Tüfekçi in 2015 and the Cronbach Alpha value was 0.88.
次要结局
未报告次要终点
研究者
Gamzegül ALTAY
Assistant Professor of Child Health and Disease Nursing
Recep Tayyip Erdogan University