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

Not Applicable

Completed

• Conditions: Pain; Newborn; Stress
• Interventions: Device: Automatic lancet

• Registration Number: NCT05448508
• Lead Sponsor: Ataturk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-05-30
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-02
• Last Update Submitted: 2022-07-02
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Automatic Lancet	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.

Primary Outcome Measures

Name	Time	Method
Crying time in second	12 week
The neo pain assessment scale	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.

Trial Locations

Locations (1)

AtaturkU; 🇹🇷 Yakuti̇ye, Erzurum, Turkey