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Completed

NCT Number: NCT07479589

The Effect of Facilitated Tucking Positions

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.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Hospital

Karaman, 7000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone Facilitated Tucking Position

Other

Prone Facilitated Tucking Position

Lateral Facilitated Tucking Position group

Other

Lateral Facilitated Tucking Position group

Supine Facilitated Tucking Position group

Other

Supine Facilitated Tucking Position group

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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