- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462884
Nestıng Technıque for Paın Management Durıng Heel Prick in Term Neonates (Nestıng)
Background: Determining the effectiveness of pain management strategies in newborns provide evidence to promote high-quality midwifery practices.
Purpose: The aim of the research is to evaluate the effect of the nesting technique on pain response during heel prick blood sampling in newborns.
Method: During the heel prick blood collection procedure at a university hospital, pain responses were evaluated in 29 full-term newborns who were held in a nest made of specially designed pillows for 3 minutes before, during, and after the procedure, and in 30 full-term newborns who underwent the routine procedure without being placed in a nest. Data were collected using the Baby Information Form, Observation Form, and the Neonatal Infant Pain Scale. A statistical software package was used for data analysis. As the data were normally distributed, the Independent t-test was used to compare group means, and Repeated Measures ANOVA was employed to assess differences over time.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled experimental trial designed to evaluate the effect of the nesting technique on behavioral and physiological outcomes - specifically pain scores, crying duration, respiratory rate, heart rate, and SpO₂ - measured at three time points: baseline (before the procedure), during the procedure, and during recovery (after the procedure).
Hypotheses H₀: The nesting technique has no significant effect on newborns' pain, crying duration, heart rate, oxygen saturation, or respiratory rate during heel prick blood sampling.
H₁: The nesting technique has significant effect on newborns' pain, crying duration, heart rate, oxygen saturation, or respiratory rate during heel prick blood sampling.
Sample Inclusion criteria for the study included term newborns undergoing routine heel prick blood sampling, with a birth weight between 2500 g and 4000 g, not receiving any medications, and whose parents provided consent for participation. The sample size was determined through a power analysis based on the Neonatal Infant Pain Scale (NIPS) score averages at the third measurement time point. The effect size, calculated as Cohen's d = 0.83, was derived from the difference between the intervention (2.06 ± 2.83) and control (4.44 ± 2.93) groups. For two independent groups, with a 95% confidence level (α = 0.05) and 80% statistical power (1-β = 0.80), it was determined that each group required at least 25 newborns. The study was completed with a total of 59 newborns, comprising 29 in the intervention group and 30 in the control group.
Intervention The study was conducted at a university hospital between May and August, 2024. Detailed information about the study was provided to the parents of eligible newborns, and written and verbal informed consent was obtained. Newborns were randomized by an independent researcher not involved in the intervention, using an online random list generator, namely, Random.org website, to ensure randomization. The randomization list was provided to the researchers performing the interventions in sealed envelopes to prevent bias during the study process. The study was conducted as a single-blind trial in which the researcher performing data analysis was blinded to group allocation; the clinical staff implementing the procedures could not be blinded due to the visible nature of the intervention.
In the intervention group, the nesting technique was applied prior to the heel prick procedure. The nesting technique involved positioning the newborn in a lateral position with hands and legs flexed, without restricting movement, using specially prepared support materials (cotton-filled pillows) to create a nest that contacted all body surfaces. The newborn was kept in the nest for 3 minutes. Physiological parameters and the NIPS were assessed at the end of the 3-minute period. The heel prick procedure, performed by the clinical midwife, was followed by assessments of physiological parameters and NIPS during the procedure. After the procedure, the nesting technique was applied for an additional 3 minutes, and physiological parameters and NIPS were evaluated at the end of this period.
In the control group, newborns were kept in their natural position on the bed for 3 minutes before the heel prick procedure, with physiological parameters and NIPS assessed at the end of this period. The heel prick procedure, performed by the clinical midwife, was followed by assessments of physiological parameters and NIPS during the procedure. After the procedure, newborns were kept in their natural position for 3 minutes, and physiological parameters and NIPS were evaluated at the end of this period (Figure 1) Data Collection Data were collected using the "Infant Information Form," a 5-parameter "Observation Form" for assessing physiological changes, and the NIPS.
Procedural Standardization Heel lances were performed 30-45 minutes after feeding while infants were awake or in light sleep. Procedures were done solely for postnatal screening and not combined with other caregiving activities to avoid confounding stimuli.
Data Analysis IBM SPSS Statistics version 29.0 was used for all analyses. Descriptive statistics, including frequency, percentage, mean, and standard deviation, were calculated. The dataset was subjected to preliminary analyses to test assumptions of normality and homogeneity of variance. Normality was assessed using the Kolmogorov-Smirnov test. As the data followed a normal distribution, parametric tests were used. The Independent Samples t-test was employed to compare means between groups. Repeated Measures Analysis of Variance (ANOVA) was used to evaluate significant differences in measurements over time. A significance level of p ≤ 0.05 was adopted for all analyses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mersin
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Mersin, Mersin, Turkey (Türkiye), (333) 43_-____
- Mersin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Term newborns undergoing routine heel prick blood
- Weight between 2500 g and 4000 g,
- Not receiving any medications, and Whose parents provided consent for participation.
Exclusion Criteria:
- Newborns with any medical condition that could affect physiological or behavioral responses,
- Infants who were clinically unstable or receiving medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nesting technique
Newborns in the intervention group will undergo a nesting technique before heel prick blood sampling.
|
In the nesting technique, the baby will be held in a supine position with hands and legs flexed, without restricted movement, in a nest made of specially prepared support materials (specially prepared pillows filled with cotton) that will make contact with all surfaces of the baby's body.
|
|
No Intervention: Control group
Newborns in the control group will be kept in their natural position on the bed during the heel prick blood test without any sedatives.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Total Score on the Neonatal Infant Pain Scale
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
|
The scale aims to determine newborn pain using 6 criteria: facial expression (0-1 points), crying (0-2 points), breathing pattern (0-1 points), arm movements (0-1 points), leg movements (0-1 points), and wakefulness level (0-1 points).
Higher scores indicate a stronger pain response.
|
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Heart Rate
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
|
Physiological and behavioral parameters
|
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
|
|
Mean Respiratory Rate
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
|
Physiological and behavioral parameters
|
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
|
|
Mean Oxygen Saturation
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
|
Physiological and behavioral parameters
|
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
|
|
Mean Crying Duration
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
|
Physiological and behavioral parameters
|
Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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