nctId: NCT06283771 id: TU-BOZKUL-007 briefTitle: The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-09-15 date: 2025-05-15 date: 2024-02-28 date: 2024-03-01 name: Tarsus University class: OTHER name: Mersin University briefSummary: In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\*Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy conditions: Wearable Technology conditions: Hypothermia conditions: Shivering conditions: Thermal Comfort Perception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study primaryPurpose: OTHER masking: TRIPLE maskingDescription: An independent biostatistician, who is not involved in the study, will select 70 individuals from the list of students enrolled between 1-250 by computer-generated randomization. The information that the volunteers included in the research sample were assigned to group A (experimental) and B (control) according to the randomization table will be kept by the researcher and the socks with the same appearance, with and without heating feature will be numbered from 1 to 70 according to the randomization table and given to the researcher. Thus, the practitioner will be blinded as he/she does not know which sock has a heating feature and which one does not. Healthy volunteers will be blinded because they do not know which group they are in. The data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Heated socks to be developed with wearable technology measure: Body temperature measure: Shivering level measure: Thermal comfort perception measure: Descriptive Characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False