The Effect of Warmed Socks Developed as Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering

Tarsus University

Status: Not yet enrolling

Conditions: Thermal Comfort Perception; Wearable Technology; Shivering; Hypothermia

Treatments: Other: Heated socks to be developed with wearable technology

Study type: Interventional

Funder types: Other

Identifiers

NCT06283771

TU-BOZKUL-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

EXPERIMENTAL GROUP

Experimental group

Description:

The study group will wear heated socks to be developed with wearable technology

Treatment:

Other: Heated socks to be developed with wearable technology

CONTROL GROUP

No Intervention group

Description:

The control group will wear socks that look exactly the same as the heated socks developed with wearable technology worn by the study group, but with a closed heating circuit.