Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2026-02-25
2026-05-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Buzzy
Vibration Application with Buzzy® Before Heel Lance
Foot bath
The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.
The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.
The video recording will be stopped once bleeding has ceased at the end of the procedure.
The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.
Shotblocker
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.
Foot bath
The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.
The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.
The video recording will be stopped once bleeding has ceased at the end of the procedure.
The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.
Interventions
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Foot bath
The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.
The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.
The video recording will be stopped once bleeding has ceased at the end of the procedure.
The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Infants with congenital anomalies or requiring respiratory support
* Infants receiving sedative or analgesic treatment
4 Days
1 Month
ALL
Yes
Sponsors
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Atlas University
OTHER
Responsible Party
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Sermin Dinc
Assistant Professor
Principal Investigators
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sermin dinç, Dr.
Role: PRINCIPAL_INVESTIGATOR
Atlas University
Locations
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Atlas University
Istanbul, Kağıthane, Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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The effect of the ShotBlocker® and breastfeeding on pain and comfort level during heel lance procedure in newborns: randomized controlled trial
Other Identifiers
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E-22686390-050.99-84286
Identifier Type: -
Identifier Source: org_study_id
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