The Effect of Facilitated Tucking Positions

NCT07479589 | Completed

• 1 other identifier: KMU-SBF-VAC-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Nursing Caries; Newborn; Vitality

Keywords

pain; Newborn; Pediatric Nursing

Outcome Measures

Primary Outcomes (2)

• Neonatal infant pain scale

  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

  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 Outcomes (2)

• Physiological parameters of newborns: heart rate (minute)

  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: 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.

Study Arms (3)

Prone Facilitated Tucking Position

EXPERIMENTAL

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

Lateral Facilitated Tucking Position group

EXPERIMENTAL

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

Supine Facilitated Tucking Position group

EXPERIMENTAL

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

Interventions

Prone Facilitated Tucking Position OTHER

Prone Facilitated Tucking Position

Prone Facilitated Tucking Position

Lateral Facilitated Tucking Position group OTHER

Lateral Facilitated Tucking Position group

Lateral Facilitated Tucking Position group

Supine Facilitated Tucking Position group OTHER

Supine Facilitated Tucking Position group

Supine Facilitated Tucking Position group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Public Hospital

Karaman, Karaman, 7000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the study, an informed consent form was created for each group, and only the parents were blinded. Two senior undergraduate nurses, blinded to the study's aims and hypotheses, were selected as observers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: This study was conducted in a randomized experimental parallel design.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: October 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: December 10, 2023
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)