Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-01 @ 10:16 AM
Study NCT ID:
NCT05228366
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-armed randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prosedüre time measure', 'timeFrame': 'During the procedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Total crying time', 'timeFrame': 'Up to 5 minutes after the heel stick', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heel warming', 'Heel Lance', 'Newborn', 'Total crying time', 'Processing time'], 'conditions': ['Nursing Caries']}, 'referencesModule': {'references': [{'pmid': '24476226', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMethod: 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.\n\nThe sample of the study was determined as 120 healthy term newborn (40 control, 40 intervention 1, 40 intervention 2).\n\nIntervention: 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.\n\nData collection instruments: Newborn Information Form (NIF).\n\nData 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'minimumAge': '24 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Born between 38-42 gestational weeks (term newborns)\n* Newborns with a birth weight of 2500-4400 grams\n* Newborns with stable physiological parameters and general condition\n* Newborns with vitamin K and hepatitis B vaccine in the delivery room\n* Newborns with eight or more Apgar scores in the first and fifth minutes\n\nExclusion Criteria:\n\n* Newborns with problems during pregnancy, labor and postpartum\n* Newborns with congenital anomaly\n* Newborns receiving pharmacological or non-pharmacological pain management intervention before the procedure\n* Newborns with receiving oxygen therapy\n* Newborns with having undergone a surgical procedure\n* Newborns with sepsis or suspected sepsis\n* Newborns whose parents state that they want to leave the study while the study continues'}, 'identificationModule': {'nctId': 'NCT05228366', 'briefTitle': 'Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance', 'organization': {'class': 'OTHER', 'fullName': 'Isparta University of Applied Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IspartaUASNursingCare2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heel warming with mild thermofor group', 'description': '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.', 'interventionNames': ['Other: Heel warming with mild thermofor group']}, {'type': 'EXPERIMENTAL', 'label': 'Heel warming with hot thermofor group', 'description': '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.', 'interventionNames': ['Other: Heel warming with hot thermofor group']}, {'type': 'OTHER', 'label': 'Ineffective heel warming with thermofor group', 'description': '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.', 'interventionNames': ['Other: Ineffective heel warming with thermofor group']}], 'interventions': [{'name': 'Heel warming with mild thermofor group', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Heel warming with mild thermofor group']}, {'name': 'Heel warming with hot thermofor group', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Heel warming with hot thermofor group']}, {'name': 'Ineffective heel warming with thermofor group', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Ineffective heel warming with thermofor group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32100', 'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Isparta University of Applied Sciences', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}], 'overallOfficials': [{'name': 'Fahriye PAZARCIKCI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Isparta University of Applied Sciences, Isparta, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'N/O'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isparta University of Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}