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

• Sponsor: Ataturk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05448508
• Collaborator: MSc Meral Güven (Other), MSc Reyhan YALÇIN (Other), PhD Adem ASLAN (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 20.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborn; Pain; Stress	Device: Automatic lancet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
• Actual Study Start Date: Apr 1, 2022
• Actual Primary Completion Date: May 30, 2022
• Actual Study Completion Date: Jul 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. Crying time in second [12 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Days to 1 Day
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AtaturkU	Yakuti̇ye	Erzurum	Turkey	25000

Sponsors and Collaborators

• Ataturk University
• MSc Meral Güven
• MSc Reyhan YALÇIN
• PhD Adem ASLAN

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Türkan Kadiroğlu, Director, Ataturk University
• ClinicalTrials.gov Identifier: NCT05448508
• Other Study ID Numbers: TKP-2022-10664
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 7, 2022