Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance

March 9, 2023 updated by: Isparta University of Applied Sciences

The Effect of Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance on Total Crying Time and Procedure Time in Healthy Term Newborns.: A Randomized Clinical Trial

Heel warming with thermophor during heel blood collection is a cost-effective and easy-to-apply method. In previous studies, it has been shown that applying heat to the heel reduces the pain of taking heel blood, increases comfort and shortens the procedure time and total crying time. Warm aplication increases the skin surface temperature, causing proximal vasodilation, thereby accelerating blood flow and increasing blood circulation. Increased blood circulation can reduce the pressure applied to the heel of newborns, shorten the procedure time, reduce the perception of pain and increase comfort. As a result of the literature review, it is seen that there is no clarity about the temperature degrees used in heel heating. It has been seen in the literature that warming the heel before heel blood collection is often carried out as mild (34-37C) or hot (38-40C). This study aims to determine heel warming with mild (34-37C) and hot (38-40C) thermofor applied before heel lance on total crying time and procedure time in healthy term newborns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: The effect of heel warming with mild (34-37C) and hot (38-40C) thermofor applied before capillary heel blood sampling on total crying time and procedure time in term newborns.

Method: This study was planned as a randomized controlled, experimental, double-blind, single-center study. The universe of the research will be term newborns whose heel blood samples will be taken within the scope of the Newborn Screening Program (NSP) in the Isparta Şehir Hospital Gynecology and Obstetrics III Service.

The sample of the study was determined as 120 healthy term newborn (40 control, 40 intervention 1, 40 intervention 2).

Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group; heel warming with mild (34-37C) thermofor will be applied to the intervention group 1; heel warming with hot (38-40C) thermofor will be applied to the intervention group 2. All newborns will breastfed from their mothers during and after the procedure.

Data collection instruments: Newborn Information Form (NIF).

Data collection: Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the puncture heel. The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Isparta, Turkey, 32100
        • Isparta University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born between 38-42 gestational weeks (term newborns)
  • Newborns with a birth weight of 2500-4400 grams
  • Newborns with stable physiological parameters and general condition
  • Newborns with vitamin K and hepatitis B vaccine in the delivery room
  • Newborns with eight or more Apgar scores in the first and fifth minutes

Exclusion Criteria:

  • Newborns with problems during pregnancy, labor and postpartum
  • Newborns with congenital anomaly
  • Newborns receiving pharmacological or non-pharmacological pain management intervention before the procedure
  • Newborns with receiving oxygen therapy
  • Newborns with having undergone a surgical procedure
  • Newborns with sepsis or suspected sepsis
  • Newborns whose parents state that they want to leave the study while the study continues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heel warming with mild thermofor group
Heel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service.
Other: Heel warming with mild thermofor group
Heel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service
Experimental: Heel warming with hot thermofor group
Heel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service.
Other: Heel warming with hot thermofor group
Heel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service
Other: Ineffective heel warming with thermofor group
Ineffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service.
Other: Ineffective heel warming with thermofor group
Ineffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosedüre time measure
Time Frame: During the procedure
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total crying time
Time Frame: Up to 5 minutes after the heel stick
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the total crying time will be recorded.
Up to 5 minutes after the heel stick

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isparta University of Applied Sciences

Investigators

  • Study Director: Fahriye PAZARCIKCI, Isparta University of Applied Sciences, Isparta, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

October 18, 2022

Study Completion (Actual)

October 18, 2022

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IspartaUASNursingCare2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/O

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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