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NCT Number: NCT07348731

Non-Pharmacological Methods in Heel Lance

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.

Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

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Key information

Age range

4 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlas University

Istanbul, Kağıthane, 34098, Turkey (Türkiye)

Location status: Recruiting

About this study

This study was designed to investigate the effects of three different non-pharmacological interventions applied prior to heel lance on the vital parameters and pain levels of newborns. The study population consists of term newborns who meet the inclusion criteria, and the sample includes newborns who present with their parents to a state hospital for heel lance and meet these criteria. Following ethical approval, data will be collected between November 2025 and November 2026. Data collection will be carried out by Özlem Kum, a graduate student actively working in the relevant clinic and responsible for performing the procedures.

Pain will be assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates procedural pain in both preterm and term newborns. The scale includes five behavioral indicators (facial expression, leg movement, arm movement, crying, and state of arousal) and one physiological indicator (respiratory pattern), with total scores ranging from 0 to 7. A 16-item Information Form containing maternal and neonatal characteristics will also be used. Statistical analyses will be performed using SPSS version 26, including frequency, percentage, mean, standard deviation, t-test, ANOVA, and Pearson correlation analyses.

Heel lance is one of the most frequently performed invasive procedures in the neonatal period. The pain and stress experienced during this procedure may lead to changes in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management strategies is essential for improving the quality of nursing care.

Non-pharmacological methods such as warm foot bath, ShotBlocker®, and the Buzzy® device are commonly used to reduce procedural pain through different mechanisms, including increased peripheral circulation, mechanical stimulation, vibration, and cold application. However, studies comparing the effects of these methods on newborns' heart rate, respiratory rate, oxygen saturation, and pain levels are limited.

This study will be conducted with approximately 90 clinically stable term newborns (37-42 weeks of gestation) in the Neonatal Unit of Kocaeli City Hospital. Data will be collected at three time points-before, during, and after the procedure-and changes in heart rate, respiratory rate, and oxygen saturation will be recorded. With parental consent, the procedure will be video-recorded at all stages, and anonymized recordings will be shared with experts for pain assessment.

The findings of this study are expected to contribute to the identification of effective non-pharmacological methods that can be used during painful procedures such as heel lance and to support the development of evidence-based practices in neonatal nursing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Newborns with a gestational age of ≥37 weeks
  • Newborns in the neonatal period (0-28 days)
  • Stable vital signs
  • Obtained informed consent from the parents
  • No use of analgesics or sedatives within the 24 hours before the procedure
  • Absence of any respiratory problems
  • First-time heel lance procedure
  • No condition that would interfere with pain assessment

Exclusion criteria

  • Preterm or low birth weight infants (< 2500 g)
  • Infants with congenital anomalies or requiring respiratory support
  • Infants receiving sedative or analgesic treatment

Treatment and study plan

Foot bath

Behavioral

The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes.

The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine.

The video recording will be stopped once bleeding has ceased at the end of the procedure.

The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.

Primary outcomes

  1. Neonatal Infant Pain Scale

    Time frame: 0 minutes (T0)

    Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain) moderate pain, >4 = severe pain)

  2. Neonatal Infant Pain Scale

    Time frame: 5th minutes 1st (T1)

    Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)

  3. Neonatal Infant Pain Scale

    Time frame: 10th minutes (T2)

    Min. 0-Max. 7 points (0-2 = mild to no pain, 3-4 = mild to moderate pain, >4 = severe pain)

  4. Heart Rate

    Time frame: 0 min (T0)

    beats/min.

  5. Heart Rate

    Time frame: 5th min 1st (T1)

    beats/min.

  6. Heart Rate

    Time frame: 10th minutes (T2)

    beats/min.

  7. Respiratory rate

    Time frame: 0 min (T0)

    respiration/minute

  8. Respiratory rate

    Time frame: 5th min 1st (T1)

    respiration/minute

  9. Respiratory rate

    Time frame: 10th minutes (T2)

    respiration/minute

  10. Saturation level

    Time frame: 0 min (T0)

    %100

  11. Saturation level

    Time frame: 5th min 1st (T1)

    %100

  12. Saturation level

    Time frame: 10th minutes (T2)

    %100

Secondary outcomes

  1. The infant's crying duration

    Time frame: From start to end of the procedure

    minutes

Other outcomes

  1. Duration of the procedure

    Time frame: From start to end of the procedure

    minutes

Study contacts

Contact information is provided by the study sponsor or research team.

Sermin Dinc, Dr.

CONTACT

[email protected]

5424033430 ext. +90

sermin dinç, Dr.

CONTACT

[email protected]

5424033430 ext. +90

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Comparison of the Effects of Foot Bath, ShotBlocker®, and Buzzy® on Neonatal Vital Signs During Heel Lance

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jun 2, 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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