The Effect of Facilitated Tucking Positions

March 15, 2026 updated by: Vildan Apaydın Cırık, Karamanoğlu Mehmetbey University

The Effect of Facilitated Tucking Positions on Pain, Comfort, Peak Heart Rate, and Oxygen Saturation of Newborns During Heel Stick Sampling

This study aim to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study employed a randomized experimental parallel design to evaluate the impact of supine, lateral, and prone positions on the pain, comfort, peak heart rate, and oxygen saturation of newborns during heel stick sampling. The study was conducted with 120 newborns between 10 October and 10 December 2023 at the Infant Monitoring Unit of Karaman Training and Research Hospital. Data were collected using the "Newborn Introduction Form, the Physiological Measurement Form, the Neonatal Infant Pain Scale, and the Newborn Comfort Behavior Scale." Statistical analyses included descriptive statistics, one-way ANOVA, ANOVA, the chi-square test, Cohen Kappa Analysis, and Spearman Correlation analysis for repeated measures. The study found that newborns in the prone position exhibited higher peak heart rates and lower oxygen saturation levels during and after heel pricks compared to other positions (p<0.05). The lateral, supine, and prone positions effectively reduced pain and distress and increased comfort. The lateral fetal position was particularly effective in significantly reducing pain and distress compared to the prone position (p<0.05). However, the mean comfort score was highest in the prone position and lowest in the lateral position (p<0.05). In conclusion, the study showed that the lateral fetal position had significant effects on peak heart rate, oxygen saturation, pain, distress, and comfort values.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Karaman
      • Karaman, Karaman, Turkey (Türkiye), 7000
        • Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The newborn must be at term (born at 38 weeks or later)
  • The newborn must be in the neonatal period (0-28 day)
  • Their vital signs must be stable
  • They must have spontaneous breathing
  • The heel prick blood sample must be taken by the same nurse
  • The lancet must be inserted only once during the heel prick blood sample collection
  • The newborn must have been fed at least 30 minutes prior
  • The families must consent to participate in the study and sign the informed consent form.

Exclusion Criteria:

  • Having a congenital anomaly
  • Having received pain medication in the last 24 hours
  • Having received sedatives in the last 24 hours,
  • Having received oxygen therapy
  • Having a congenital anomaly
  • Having a history of seizures
  • Having a health problem that prevents positioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prone Facilitated Tucking Position
The prone fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded.
Other: Prone Facilitated Tucking Position
Prone Facilitated Tucking Position
Experimental: Lateral Facilitated Tucking Position group
The lateral fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded.
Other: Lateral Facilitated Tucking Position group
Lateral Facilitated Tucking Position group
Experimental: Supine Facilitated Tucking Position group
The supine fetal position, applied by the researcher according to the groups, was started 3 minutes before the heel prick blood test, continued throughout the procedure, and continued for up to 5 minutes after the procedure. One minute before, during, and one minute after heel prick blood sampling, the newborns' pain and comfort levels were observed, assessed, and recorded by two independent nurses. In addition, the newborns' heart rate and oxygen saturation levels were also recorded.
Other: Supine Facilitated Tucking Position group
Supine Facilitated Tucking Position group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neonatal infant pain scale
Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
The scale is used in term and preterm infants up to the 6th postnatal week. The scale is evaluated based on the nurse's observation. Six items are rated between 0-1 points, while one item is rated between 0-2 points. The scale comprises six behavioral items: facial expression, crying, breathing pattern, arms, legs, and alertness. A higher score on the scale indicates increased pain intensity.
The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Newborn Comfort Behavior Scale
Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
The scale is a Likert-type scale with six parameters: alertness, calmness/agitation, body movements, facial tension, and muscle tone. The lowest possible score for a newborn on the scale is 6, and the highest is 30. A total score between 14 and 30 indicates the presence of pain or distress in the newborn, suggesting a lack of comfort. Nurses or observers rate newborns' pain and distress on numerical rating scales ranging from 0 to 10. Scores between 7 and 10 indicate severe pain and distress.
The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological parameters of newborns: heart rate (minute)
Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Heart rate value was recorded 1 minute before, during, and 1 minute after the heel prick blood test. Pulse oximeters were attached to the upper extremities of the newborns included in the study and monitored.
The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Physiological parameters of newborns: oxygen saturation (%SpO2)
Time Frame: Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.
Description: %SpO2 value was recorded 1 minute before, during, and 1 minute after the heel prick blood test. Pulse oximeters were attached to the upper extremities of the newborns included in the study and monitored.
Time Frame: The newborn was assessed 1 minute before heel stick sampling. The newborn was assessed during heel stick sampling. The newborn was assessed 1 minute after heel stick sampling.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karamanoğlu Mehmetbey University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMU-SBF-VAC-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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