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Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies? (w-pi)

Primary Purpose

Pain, Acute, Premature

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
warm group/cold group
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute focused on measuring premature, pain score, Picc line

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • University of Health Sciences Istanbul Umraniye Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

warm skin desenfection group

cold skin desenfection group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

change feeling of pain and restlessness in premature
Evaluation of pain score in the patient during the procedure with n-pass evaluation

Secondary Outcome Measures

protection of body temperature
body temperature monitoring before and during the incubator with skin temperature probe

Full Information

First Posted
July 1, 2020
Last Updated
March 6, 2022
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators
Umraniye Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04458441
Brief Title
Can Warm Skin Disinfection Reduce the Pain Peripheral Central Catheter Application in Premature Babies?
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
September 5, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators
Umraniye Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Premature
Keywords
premature, pain score, Picc line

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
warm skin desenfection group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cold skin desenfection group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
warm group/cold group
Intervention Description
sequential randomization
Primary Outcome Measure Information:
Title
change feeling of pain and restlessness in premature
Description
Evaluation of pain score in the patient during the procedure with n-pass evaluation
Time Frame
every 10 seconds before the 5 minutes and during the procedure
Secondary Outcome Measure Information:
Title
protection of body temperature
Description
body temperature monitoring before and during the incubator with skin temperature probe
Time Frame
before 5 min, during procedure

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
funda atay
Phone
+905054409167
Email
funday.atay@gmail.com
Facility Information:
Facility Name
University of Health Sciences Istanbul Umraniye Teaching Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
funda atay

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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