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NCT05448508 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05448508
Other study ID # TKP-2022-10664
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date July 1, 2022

Study information
Verified date July 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 1, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 1 Day
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey AtaturkU Yakuti?ye Erzurum

Sponsors (4)
Lead Sponsor Collaborator
Ataturk University MSc Meral Güven, MSc Reyhan YALÇIN, PhD Adem ASLAN

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Crying time in second 12 week
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