- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07479589
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
120
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
Supine Facilitated Tucking Position group
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
October 10, 2023
Primary Completion (Actual)
October 10, 2023
Study Completion (Actual)
December 10, 2023
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
March 15, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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