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

NCT04458441 | Unknown DMC

• 1 other identifier: 1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute; Premature

Keywords

premature, pain score, Picc line

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• protection of body temperature

  before 5 min, during procedure

Study Arms (2)

warm skin desenfection group

ACTIVE COMPARATOR

Povidion iodine will be used as a skin cleanser. povidion iodine will be heated sterile to 38 degrees with a ben-mari method and its temperature will be controlled by degrees. When it reaches the appropriate degree, the skin cleaning of the baby will be done sterile.

Other: warm group/cold group

cold skin desenfection group

NO INTERVENTION

Povidion iodine will be used as a skin cleanser. povidion iodine will be used in the skin cleaning of the baby without any heating procedure.

Interventions

warm group/cold group OTHER

sequential randomization

warm skin desenfection group

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead
• Umraniye Education and Research Hospital: collaborator

Study Sites (1)

University of Health Sciences Istanbul Umraniye Teaching Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain; Premature Birth

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

funda atay

CONTACT

+905054409167; funday.atay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: May 5, 2020
• Primary Completion: September 5, 2022
• Study Completion: December 30, 2022
• Last Updated: March 8, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)