Non-Pharmacological Methods in Heel Lance
ConditionHeel Lance Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-1
SponsorAtlas University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Preterm or low birth weight infants (< 2500 g)
Infants with congenital anomalies or requiring respiratory support
Infants receiving sedative or analgesic treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Foot bath
BehavioralThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: BuzzyExperimental treatment 1 intervention
Group B: ShotblockerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Neonatal Infant Pain Scale
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)
Time frame
0 minutes (T0)2
Neonatal Infant Pain Scale
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)
Time frame
5th minutes 1st (T1)3
Neonatal Infant Pain Scale
Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, \>4 = severe pain)
Time frame
10th minutes (T2)4
Heart Rate
beats/min.
Time frame
0 min (T0)Secondary outcomes
1
The infant's crying duration
minutes
Time frame
From start to end of the procedureOther outcomes
1
Duration of the procedure
minutes
Time frame
From start to end of the procedureSponsors and contacts
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Source ClinicalTrials.gov