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Nesting Technique During Heel Prick Blood CollectionNestıngNCT07462884

Nestıng Technıque for Paın Management Durıng Heel Prick in Term Neonates

A study testing Nesting technique in people with Nesting Technique During Heel Prick Blood Collection and Natural Position During Heel Prick Blood Collection, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 day to 1 weekHealthy volunteers can take part
What is being tested?
Nesting technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2024to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 1 week
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Newborns with any medical condition that could affect physiological or behavioral responses,
  • Infants who were clinically unstable or receiving medication

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University

    Mersin, Mersin, (333) 43_-____

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Nesting technique
Keywords
infant, newborn, pain management, midwifery, nesting technique
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nesting techniqueProcedure or surgery

    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.

Study groups in NCT07462884
Study groupRoleWhat they receive
Nesting techniqueExperimentalNewborns in the intervention group will undergo a nesting technique before heel prick blood sampling.
Receives: Procedure: Nesting technique
Control groupNo interventionNewborns 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Total Score on the Neonatal Infant Pain Scale

    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.

    Measured: 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 (4)
  1. Mean Heart Rate

    Physiological and behavioral parameters

    Measured: Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period

  2. Mean Respiratory Rate

    Physiological and behavioral parameters

    Measured: Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period

  3. Mean Oxygen Saturation

    Physiological and behavioral parameters

    Measured: Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period

  4. Mean Crying Duration

    Physiological and behavioral parameters

    Measured: Baseline (end of 3-minute pre-procedure period), during heel prick procedure, and at the end of the 3-minute post-procedure period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start1 Jan 2024
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462884
Sponsor's protocol ID
2023/833
Acronym
Nestıng
Status last verified
Mar 2026
First submitted
23 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nesting technique in people with Nesting Technique During Heel Prick Blood Collection and Natural Position During Heel Prick Blood Collection, run by Mersin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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