Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?

Pain, Acute Clinical Trial

— w-pi  

Official title:

Does Warm Skin Disinfection Reduce the Pain Score or Increase the Application Success in Peripheral Central Catheter Application in Premature Babies?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458441
• Other study ID #: 1001
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2021
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: funda atay
• Phone: +905054409167
• Email: funday.atay[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral central catheter application, especially in extremely low birth weight premature babies, is an intensive care follow-up procedure. There are many clinical studies in areas such as catheter type, skin disinfection, catheter duration, catheter infection. In our practice, it was observed that premature baby was less uncomfortable, the number of trials decreased, and the change in body temperature was less with the application of hot skin disinfection in our practice. With a prospective randomized study, the investigators wanted to document their observational data scientifically.

Description:

Babies under 32 gestation week and 1250 g who are treated at level 3 NICU and need peripheral central catheter will be included in the study. In the preparation of peripheral central catheter application, skin cleaning is performed with povidone iodine in our clinic. The investigators used during the povidione iodine preparation phase after heating the bain-marie method with sterile conditions. The investigators predicted that the premature baby would have less discomfort with warm povidion iodine. To demonstrate this, it was planned to take both video recordings during the application and N-PASS evaluation by an experienced person who does not know the povidone iodine temperature used .In preparation of the catheter except the person who did povidone iodine skin cleansing, nobody knows the heat. The catheters were administered by a single experienced person. The study was designed to be unaware of the povidin iodine application temperature of the person applying the catheter and the N-PASS assessment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria: below 32 gestational weeks and / or 1250 grams preterm babies neonates requiring total parenteral nutrition, antibiotic therapy for at least 7 days, -

Exclusion Criteria: major congenital anomalilies refusal to sign consent patient with previously attemped or placed central lines

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Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Premature
• Premature Birth

Intervention

Other:
• warm group/cold group
sequential randomization

Locations

Country	Name	City	State
Turkey	University of Health Sciences Istanbul Umraniye Teaching Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital	Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change feeling of pain and restlessness in premature	Evaluation of pain score in the patient during the procedure with n-pass evaluation	every 10 seconds before the 5 minutes and during the procedure
Secondary	protection of body temperature	body temperature monitoring before and during the incubator with skin temperature probe	before 5 min, during procedure