Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT05228366
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.
Detailed Description:
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.
Study:
NCT05228366
Study Brief:
Protocol Section:
NCT05228366