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Completed

NCT Number: NCT05228366

Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance

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.

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Key information

Conditions

Nursing Caries

Age range

24 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isparta University of Applied Sciences

Isparta, 32100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heel warming with mild thermofor group

Other

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

Heel warming with hot thermofor group

Other

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

Ineffective heel warming with thermofor group

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Isparta University of Applied Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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