Foot Bath for Heel Warming Before Heel Lance

NCT05220930 | Completed DMC

• 1 other identifier: IspartaUASNursingCare
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Caries

Keywords

Foot bath; Heel warming; Heel Lance; Newborn; Pain

Outcome Measures

Primary Outcomes (1)

• Prosedüre time measure

  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 Outcomes (1)

• NIPS (Neonatal Infant Pain Scale)

  Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).

Study Arms (2)

Foot bath for heel warming group

EXPERIMENTAL

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

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

Interventions

Foot bath for heel warming OTHER

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.

Foot bath for heel warming group

Ineffective heel warming with thermofor 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
• Akdeniz University: collaborator

Study Sites (1)

Isparta University of Applied Sciences

Isparta, 32100, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• Unal C, Welcome MO, Salako M, Abdullahi F, Abubakar NM, Pereverzev VA, Hartiningsih SS, Dane S. The effect of foot reflexotherapy on the dynamics of cortical oscillatory waves in healthy humans: An EEG study. Complement Ther Med. 2018 Jun;38:42-47. doi: 10.1016/j.ctim.2018.03.006. Epub 2018 Mar 20.

  PMID: 29857878 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fahriye PAZARCIKCI, PhD

  Isparta University of Applied Sciences

  STUDY DIRECTOR

• Ayla KAYA, PhD

  Akdeniz University

  STUDY CHAIR

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: Parallel Assignment

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 2, 2022
• Study Start: May 11, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: February 3, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)