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).
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
- Conditions the study is for
- Nesting Technique During Heel Prick Blood Collection, Natural Position During Heel Prick Blood Collection
- 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_-____
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.
- Conditions
- Nesting Technique During Heel Prick Blood Collection, Natural Position During Heel Prick Blood Collection
- 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 group | Role | What they receive |
|---|---|---|
| Nesting technique | Experimental | Newborns in the intervention group will undergo a nesting technique before heel prick blood sampling. Receives: Procedure: Nesting technique |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted10 Mar 2026
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nesting Technique During Heel Prick Blood CollectionStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Meltem Aydın Beşen, Mersin University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nestıng Technıque for Paın Management Durıng Heel Prick in Term Neonates
- ClinicalTrials.gov ID
- NCT07462884
- Acronym / sponsor ID
- Nestıng / 2023/833
- Conditions
- Nesting Technique During Heel Prick Blood Collection, Natural Position During Heel Prick Blood Collection
- Keywords
- infant, newborn, pain management, midwifery, nesting technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesting technique | Experimental | Procedure: Nesting techniqueNewborns in the intervention group will undergo a nesting technique before heel prick blood sampling. |
| Control group | No intervention | –Newborns in the control group will be kept in their natural position on the bed during the heel prick blood test without any sedatives. |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Newborns with any medical condition that could affect physiological or behavioral responses,
- Infants who were clinically unstable or receiving medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nesting techniqueIn 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. | Procedure or surgery | Nesting technique |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.