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OpenTrials
Completed

NCT Number: NCT05448508

The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection

Heel blood sampling is a routine but painful procedure for newborns. A limited number of international studies have shown that automatic lancets are more effective with less pain and tissue damage than manual lancets.

In line with this information, this study was planned to investigate the effects of manual and automatic lancets on pain and stress in newborn capillary heel blood collection.

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Key information

Conditions

Newborn Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AtaturkU

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Postnatal age zero day
  • Term newborn
  • No congenital anomalies
  • No advanced medical intervention at birth
  • Infants not receiving oxygen or respiratory support

Exclusion criteria

  • Legal guardian not giving consent to research

Treatment and study plan

Automatic lancet

Device

An automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies.

Primary outcomes

  1. The neo pain assessment scale

    Time frame: 12 week

    The neo scale was developed (2014) to assess pain and stress in premature and mature neonates. The Neo is a five-item scale including facial expression, breathing pattern, tone of extremities, hand and foot activity, and level of activity. The lowest and the highest scores obtainable from the scale are 0 and 10, respectively. As the score increases, stress and pain increase.

  2. Crying time in second

    Time frame: 12 week

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • MSc Meral Güven
  • MSc Reyhan YALÇIN
  • PhD Adem ASLAN

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Jul 7, 2022

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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