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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448508
Enrollment
60
Registered
2022-07-07
Start date
2022-04-01
Completion date
2022-07-01
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn, Pain, Stress

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.

Interventions

DEVICEAutomatic lancet

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

Sponsors

MSc Meral Güven
CollaboratorUNKNOWN
MSc Reyhan YALÇIN
CollaboratorUNKNOWN
PhD Adem ASLAN
CollaboratorUNKNOWN
Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The neo pain assessment scale12 weekThe 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.
Crying time in second12 week

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026