Foot Bath for Heel Warming Before Heel Lance

February 1, 2023 updated by: Isparta University of Applied Sciences

The Effect of a Foot Bath Before Capillary Heel Blood Sampling on Pain and Procedure Time in Neonates: A Randomized Clinical Trial

Foot bath is a simple warm application method that creates a feeling of comfort and positive effects on health have been reported in the literature. There are studies reporting the benefits of footbath for different groups. However, no study has been found in the literature investigating the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time. Foot bath to be applied during heel blood collection is a cost-effective and easy-to-apply method. This study aims to determine the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time in healthy term newborns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: This study aimed to determine the effect of foot baths applied before capillary heel blood sampling for newborn on pain level and procedure duration in term newborns.

Method: This study was planned as a randomized controlled, experimental, 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 size of the study was calculated based on the first hypothesis of the study with the G*Power 3.1 program. The sample of the study was determined as 80 healthy term newborn (40 control, 40 intervention).

Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group and foot bath for heel warming will be applied to the intervention group.

Data collection instruments: Newborn Information Form (NIF), and NIPS (Neonatal Infant Pain Scale) will be used to collect data.

Data collection: In this study, the effectiveness of the intervention was pre-intervention/pre-evaluation (T1); It will be evaluated at four measurement points during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4). Measurement points were determined in accordance with the literatüre. Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the procedure. The video recording will be monitored by two independent evaluators who do not know the purpose of the study, and the NIPS scores at the measurement points and the processing time will be recorded.

Study Type

Interventional

Enrollment (Actual)

80

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
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
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.
Experimental: Foot bath for heel warming group
In this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap. Before piercing the heel, the heel will be wiped with a blanket and dried. After the intervention, blood collection from the heel will be performed by following the standard procedure steps that are routinely applied in the service.
Other: Foot bath for heel warming
In this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap.

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 two independent evaluators 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
NIPS (Neonatal Infant Pain Scale)
Time Frame: Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).
The NIPS (Neonatal Infant Pain Scale) was developed by Lawrence et al. in 1993 and tr into translated into Turkish by Akdovan in 1999 to assess pain. This scale consists of five behavioral indicators including facial expression, leg, movement, arm movement, crying and wakefulness, and one physiological indicator of respiratory rhythm. Total scores range from 0 to Higher scores show that the intensity of pain is higher. The internal consistency of NIPS was reported to be 0.95 before the transaction, 0.87 during the transaction, and 0.88 after the transaction. According to a study conducted by Akdovan et al. in 1999, the internal consistency coefficient of this scale using Cronbach's alpha was found to be between 0.83 and 0.86.
Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).

Collaborators and Investigators

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

Sponsor

Isparta University of Applied Sciences

Collaborators

Akdeniz University

Investigators

  • Study Director: Fahriye PAZARCIKCI, PhD, Isparta University of Applied Sciences
  • Study Chair: Ayla KAYA, PhD, Akdeniz University

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)

September 21, 2022

Study Completion (Actual)

September 21, 2022

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IspartaUASNursingCare

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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