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

NCT ID: NCT05448508

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-07-01

Brief Summary

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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

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Conditions

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Newborn Pain Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Automatic lancet

Intervention Type DEVICE

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

Control

No intervention, routine maintenance performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Automatic lancet

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MSc Meral Güven

UNKNOWN

Sponsor Role collaborator

MSc Reyhan YALÇIN

UNKNOWN

Sponsor Role collaborator

PhD Adem ASLAN

UNKNOWN

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Türkan Kadiroğlu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AtaturkU

Yakutiye, Erzurum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TKP-2022-10664

Identifier Type: -

Identifier Source: org_study_id

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