NCT05220930

Foot Bath for Heel Warming Before Heel Lance

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Isparta University of Applied Sciences · Academic / Other
• Sex: All
• Age: 24 Hours – 72 Hours
• Healthy volunteers: Accepted

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.

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.

Conditions

• Nursing Caries

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2022-02-02
• Last updated: 2023-02-03

Locations

1 site across 1 country: Turkey (Türkiye)