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

NCT05448508 | Completed

• 1 other identifier: TKP-2022-10664
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn; Pain; Stress

Outcome Measures

Primary Outcomes (2)

• The neo pain assessment scale

  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.

  12 week

• Crying time in second

  12 week

Study Arms (2)

Automatic Lancet

EXPERIMENTAL

Manual lancet, needle tips and automatic lancets are used in the heel blood collection process. It has been reported that there may be complications arising from health professionals in the use of manual lancet or needle tip. In this study, an automatic lancet penetrating 2.4 mm-3 mm depth was used for safe puncture in term newborns.

Device: Automatic lancet

Control

NO INTERVENTION

No intervention, routine maintenance performed

Interventions

Automatic lancet DEVICE

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

Automatic Lancet

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Legal guardian not giving consent to research

Sponsors & Collaborators

• Ataturk University: lead
• MSc Meral Güven: collaborator
• MSc Reyhan YALÇIN: collaborator
• PhD Adem ASLAN: collaborator

Study Sites (1)

AtaturkU

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (1)

• Kadiroglu T, Guven M, Yalcin R, Aslan A. The effects of manual and automatic lancet use on pain, stress, physiological parameters and crying duration during capillary heel blood collection in term neonates: a randomized controlled trial. BMC Nurs. 2025 Nov 18;24(1):1409. doi: 10.1186/s12912-025-04056-y.

  PMID: 41254729 DERIVED

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 7, 2022
• Study Start: April 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: July 1, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

TU (1)