Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance

NCT05228366 | Completed DMC

• 1 other identifier: IspartaUASNursingCare2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Caries

Keywords

Heel warming; Heel Lance; Newborn; Total crying time; Processing time

Outcome Measures

Primary Outcomes (1)

• Prosedüre time measure

  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 Outcomes (1)

• Total crying time

  Up to 5 minutes after the heel stick

Study Arms (3)

Heel warming with mild thermofor group

EXPERIMENTAL

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 with hot thermofor group

EXPERIMENTAL

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

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.

Other: Ineffective heel warming with thermofor group

Interventions

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 mild thermofor group

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

Heel warming with hot thermofor group

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.

Ineffective heel warming with thermofor group

Eligibility Criteria

• Age: 24 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isparta University of Applied Sciences: lead

Study Sites (1)

Isparta University of Applied Sciences

Isparta, 32100, Turkey (Türkiye)

Location

Related Publications (1)

• Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.

  PMID: 24476226 BACKGROUND

Study Officials

• Fahriye PAZARCIKCI

  Isparta University of Applied Sciences, Isparta, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-armed randomized controlled trial

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 8, 2022
• Study Start: May 11, 2022
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: March 14, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)