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.

Study Overview

• Status: Completed
• Conditions: Pain; Stress; Newborn
• Intervention / Treatment: Device: Automatic lancet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum
    • Yakuti̇ye, Erzurum, Turkey, 25000
      • AtaturkU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic Lancet; 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; An automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies.
No Intervention: Control; No intervention, routine maintenance performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ataturk University
• Collaborators: MSc Reyhan YALÇIN; MSc Meral Güven; PhD Adem ASLAN

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TKP-2022-10664

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No