Clinical trial NCT06283771: The Effect of Warmed Socks Developed as Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering
Official title: The Effect of Warmed Socks Developed as Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wearable Technology
Hypothermia
Shivering
Thermal Comfort Perception
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2024-02-28
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study
Primary purpose: OTHER

Brief summary: 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

Detailed description: Increasing developments in science have led to rapid advances in health technology. One of these developments is wearable technology. Wearable devices play a key role in the field of healthcare, especially since they play an active role in providing data by monitoring changes in vital signs in real time. Textile-based sensors, electrodes and other devices are used in conjunction with wearable technological devices due to their low cost, flexibility and ease of application. Existing studies have focused on the impact of wearable technologies on positive patient outcomes in different fields. However, previously developed textile-based medical products, patents or utility model examples have not been designed to prevent hypothermia in healthy adults by providing temperature control. 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, taking into account the losses with 95% power and a maximum of 5% type error in both directions. 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 analysis.

Eligibility criteria: Inclusion Criteria:

* -Written and verbal permission to participate in the study was obtained,
* No communication problems,
* Speaks and understands Turkish,
* Non-hypothermic,
* Not diagnosed with a chronic disease,
* Not allergic to sock material,
* No peripheral vascular disease,
* Without a device that sends electric current into the body (pacemaker, etc.),
* Healthy volunteers with a body mass index within normal limits (18.5-24.9 kg/m2).

Exclusion Criteria:

* Written and verbal permission to participate in the research could not be obtained,
* Communication problems,
* Speaking Turkish but not understanding it,
* Diagnosed with a chronic disease,
* Hypothermic,
* Peripheral vascular disease,
* Allergic to sock material,
* A person with a device (pacemaker, etc.) that sends electric current into the body,
* Healthy volunteers with a body mass index not within normal limits (\<18.5 kg/m2- \>25 kg/m2)

Primary outcomes:
measure: Body temperature
timeFrame: 5 months
measure: Shivering level
timeFrame: 5 months
measure: Thermal comfort perception
timeFrame: 5 months
measure: Descriptive Characteristics
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tarsus University
name: Gamze Bozkul
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Evren Değirmenci
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Murat BOZLU
role: PRINCIPAL_INVESTIGATOR
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