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临床试验/NCT07348731
NCT07348731
尚未招募
不适用

Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance

Atlas University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月25日最近更新:
干预措施Foot bath

概览

阶段
不适用
状态
尚未招募
发起方
Atlas University
入组人数
90
试验地点
1
主要终点
Neonatal Infant Pain Scale

概览

简要总结

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.

Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

详细描述

This study was designed to investigate the effects of three different non-pharmacological interventions applied prior to heel lance on the vital parameters and pain levels of newborns. The study population consists of term newborns who meet the inclusion criteria, and the sample includes newborns who present with their parents to a state hospital for heel lance and meet these criteria. Following ethical approval, data will be collected between November 2025 and November 2026. Data collection will be carried out by Özlem Kum, a graduate student actively working in the relevant clinic and responsible for performing the procedures.

Pain will be assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates procedural pain in both preterm and term newborns. The scale includes five behavioral indicators (facial expression, leg movement, arm movement, crying, and state of arousal) and one physiological indicator (respiratory pattern), with total scores ranging from 0 to 7. A 16-item Information Form containing maternal and neonatal characteristics will also be used. Statistical analyses will be performed using SPSS version 26, including frequency, percentage, mean, standard deviation, t-test, ANOVA, and Pearson correlation analyses.

Heel lance is one of the most frequently performed invasive procedures in the neonatal period. The pain and stress experienced during this procedure may lead to changes in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management strategies is essential for improving the quality of nursing care.

Non-pharmacological methods such as warm foot bath, ShotBlocker®, and the Buzzy® device are commonly used to reduce procedural pain through different mechanisms, including increased peripheral circulation, mechanical stimulation, vibration, and cold application. However, studies comparing the effects of these methods on newborns' heart rate, respiratory rate, oxygen saturation, and pain levels are limited.

This study will be conducted with approximately 90 clinically stable term newborns (37-42 weeks of gestation) in the Neonatal Unit of Kocaeli City Hospital. Data will be collected at three time points-before, during, and after the procedure-and changes in heart rate, respiratory rate, and oxygen saturation will be recorded. With parental consent, the procedure will be video-recorded at all stages, and anonymized recordings will be shared with experts for pain assessment.

The findings of this study are expected to contribute to the identification of effective non-pharmacological methods that can be used during painful procedures such as heel lance and to support the development of evidence-based practices in neonatal nursing.

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 (Outcomes Assessor)

入排标准

年龄范围
4 Days 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Newborns with a gestational age of ≥37 weeks
  • Newborns in the neonatal period (0-28 days)
  • Stable vital signs
  • Obtained informed consent from the parents
  • No use of analgesics or sedatives within the 24 hours before the procedure
  • Absence of any respiratory problems
  • First-time heel lance procedure
  • No condition that would interfere with pain assessment

排除标准

  • Preterm or low birth weight infants (\< 2500 g)
  • Infants with congenital anomalies or requiring respiratory support
  • Infants receiving sedative or analgesic treatment

研究组 & 干预措施

Buzzy

Experimental

Vibration Application with Buzzy® Before Heel Lance

干预措施: Foot bath (Behavioral)

Shotblocker

Experimental

After the information form is completed with the parent, the video recording will be initiated. The infant's vital signs will be monitored and recorded using a pulse probe, after which the ShotBlocker® will be placed on the procedure site. Following the heel lance performed with the ShotBlocker®, the time to bleeding cessation and the infant's crying duration will be recorded.

干预措施: Foot bath (Behavioral)

结局指标

主要结局

Neonatal Infant Pain Scale

时间窗: 0 minutes (T0)

Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain) moderate pain, \>4 = severe pain)

Neonatal Infant Pain Scale

时间窗: 5th minutes 1st (T1)

Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)

Neonatal Infant Pain Scale

时间窗: 10th minutes (T2)

Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)

Heart Rate

时间窗: 0 min (T0)

beats/min.

Heart Rate

时间窗: 5th min 1st (T1)

beats/min.

Heart Rate

时间窗: 10th minutes (T2)

beats/min.

Respiratory rate

时间窗: 0 min (T0)

respiration/minute

Respiratory rate

时间窗: 5th min 1st (T1)

respiration/minute

Respiratory rate

时间窗: 10th minutes (T2)

respiration/minute

Saturation level

时间窗: 0 min (T0)

%100

Saturation level

时间窗: 5th min 1st (T1)

%100

Saturation level

时间窗: 10th minutes (T2)

%100

次要结局

  • The infant's crying duration(From start to end of the procedure)

研究者

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

Sermin Dinc

Assistant Professor

Atlas University

研究点 (1)

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