Nestıng Technıque for Paın Management Durıng Heel Prick in Term Neonates
Phase: NA
Conditions: Nesting Technique During Heel Prick Blood Collection, Natural Position During Heel Prick Blood Collection
Sponsor: Mersin University

 
Official Study Title: 
Nesting Technique for Pain Management During Heel Prick in Term Neonates 
NCT Number: 
Not yet assigned 
Document Type: 
Study Protocol 
Document Date: 
23.02.2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
Study Description 
This randomized controlled experimental trial aims to evaluate the effect of the nesting 
technique on behavioral and physiological outcomes in term newborns undergoing routine heel-
prick blood sampling. 
Primary and secondary outcomes include pain scores, crying duration, respiratory rate, 
heart rate, and oxygen saturation (SpO₂), measured at three predefined time points: 
• Baseline (end of 3-minute pre-procedure period) 
• During the heel-prick procedure 
• Recovery (end of 3-minute post-procedure period) 
Study Design 
• Study Type: Interventional  
• Allocation: Randomized 
• Intervention Model: Parallel Assignment 
• Masking: No blinding of intervention administrators or outcome assessors 
• Primary Purpose: Prevention / Supportive Care 
Participants 
Inclusion Criteria 
• Term newborns (37–42 weeks gestation) 
• Birth weight between 2500 g and 4000 g 
• Undergoing routine heel-prick blood sampling 
• Not receiving any medications 
• Clinically stable 
• Parental written informed consent provided 
Exclusion Criteria 
• Preterm or post-term newborns 
• Birth weight < 2500 g or > 4000 g 
• Presence of any medical condition affecting physiological or behavioral responses 
• Clinically unstable infants 
• Receiving medication 
• Parental refusal or withdrawal of consent 
Sample Size 
Sample size calculation was based on Neonatal Infant Pain Scale (NIPS) scores at the 
third measurement time point. 
• Effect size (Cohen’s d): 0.83 
• Confidence level: 95% (α = 0.05) 
• Statistical power: 80% (1−β = 0.80) 
• Required sample: 25 newborns per group 
The study was completed with: 
• Intervention group: 29 newborns 
• Control group: 30 newborns 
• Total sample size: 59 newborns 
Randomization and Allocation Concealment 
Randomization was performed by an independent researcher using computer-generated 
random numbers via Random.org. 
Group assignments were placed in sealed, opaque envelopes. Each envelope was opened 
immediately before data collection for each newborn to ensure allocation concealment and 
minimize selection bias. 
Intervention 
Experimental Group – Nesting Technique 

The nesting intervention was initiated at least 3 minutes before the heel-prick procedure 
and maintained throughout the procedure and for 3 minutes post-procedure. 
Infants were positioned supine with full-body support using standardized cotton-covered, 
hypoallergenic silicone-filled nesting pillows. 
Positioning characteristics: 
• Head in midline 
• Upper and lower extremities in slight flexion 
• Symmetrical positioning 
• Gentle upper body coverage without pressure 
• No restriction of breathing or circulation 
The technique is not part of routine care and was implemented exclusively for research 
purposes. 
Control Group – Standard Care 
Infants were kept in their natural supine position without structured positioning support. 
Measurements were conducted: 
• After 3 minutes pre-procedure 
• During heel prick 
• After 3 minutes post-procedure 
No additional non-pharmacological pain relief methods were routinely used in either 
group. 
Outcome Measures 
Primary Outcome 
Mean Total Score on the Neonatal Infant Pain Scale (NIPS) 
Description: 
The NIPS assesses six indicators (facial expression, crying, breathing pattern, arm movements, 
leg movements, and state of arousal). Total scores range from 0 to 7, with higher scores 
indicating greater pain. 
Time 
Frame: 
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of 
the 3-minute post-procedure period. 
Secondary Outcomes 
1. Mean Heart Rate (beats per minute) 
2. Mean Respiratory Rate (breaths per minute) 
3. Mean Oxygen Saturation (SpO₂, %) 
4. Crying Duration (seconds) 
Time 
Frame 
for 
all 
secondary 
outcomes: 
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of 
the 3-minute post-procedure period. 
Data Collection Instruments 
• Infant Information Form (gestational age, birth weight, sex, delivery mode) 
• Observation Form (physiological and behavioral parameters) 
• Neonatal Infant Pain Scale (NIPS) 
Measurements: 
• Heart rate and SpO₂: neonatal pulse oximeter 
• Respiratory rate: chest observation for 1 full minute 
• Crying duration: stopwatch measurement 
Heel lances were performed 30–45 minutes after feeding while infants were awake or in 
light sleep. 
Statistical Analysis 
• Descriptive statistics: frequency, percentage, mean, standard deviation 

• Normality test: Kolmogorov-Smirnov 
• Independent Samples t-test: between-group comparisons 
• Repeated Measures ANOVA: time-based comparisons 
• Significance level: p ≤ 0.05 
Ethical Considerations 
The study was approved by the Clinical Research Ethics Committee of Mersin University 
(Approval No: 2023/833). The research was conducted in accordance with the ethical principles 
of Mersin University and complied with the Declaration of Helsinki (1964), as revised in 2013. 
Written and verbal informed consent was obtained from the parents of all participating 
newborns prior to enrollment in the study. Participation was voluntary, and parents were 
informed of their right to withdraw their infant from the study at any time without any effect 
on clinical care.