Hypothermia Clinical Trial
Official title:
The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering in Healthy Volunteers
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
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | May 15, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tarsus University | Mersin University |
Agarwal DK, Viers BR, Rivera ME, Nienow DA, Frank I, Tollefson MK, Gettman MT. Physical activity monitors can be successfully implemented to assess perioperative activity in urologic surgery. Mhealth. 2018 Sep 26;4:43. doi: 10.21037/mhealth.2018.09.05. eCollection 2018. — View Citation
Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16. — View Citation
Baskan, A., & Goncu-Berk, G. (2022). User Experience of Wearable Technologies: A Comparative Analysis of Textile-Based and Accessory-Based Wearable Products. Applied Sciences. 12(21), 11154. https://doi.org/10.3390/app122111154.
Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4. — View Citation
Burns A, Adeli H. Wearable technology for patients with brain and spinal cord injuries. Rev Neurosci. 2017 Nov 27;28(8):913-920. doi: 10.1515/revneuro-2017-0035. — View Citation
Castellani JW, Young AJ. Human physiological responses to cold exposure: Acute responses and acclimatization to prolonged exposure. Auton Neurosci. 2016 Apr;196:63-74. doi: 10.1016/j.autneu.2016.02.009. Epub 2016 Feb 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body temperature | Hypothermia Monitoring Form: It is a form in which body temperature, shivering level and temperature comfort perception of healthy volunteers are recorded. The body temperature of the healthy volunteers in the study and control groups will be measured when they are admitted to the basic skills laboratory, 15 minutes after they are admitted to the laboratory, 30 minutes after they are admitted to the laboratory, 60 minutes after they are admitted to the laboratory and when they leave the laboratory, and their shivering level and temperature comfort perception will also be measured during these periods. In this form, the measurement times of body temperature values were determined based on the literature | 5 months | |
Primary | Shivering level | Tremor Level Diagnosis Form: The form, which Badjaita et al. (2008) determined the criteria by observation, determines the level of tremor according to the tremor in the extremities between 0 (no tremor) and 3 (severe tremor in the trunk, lower and upper extremities) points. | 5 months | |
Primary | Thermal comfort perception | Hypothermia Monitoring Form: It is a form in which body temperature, shivering level and temperature comfort perception of healthy volunteers are recorded. The body temperature of the healthy volunteers in the study and control groups will be measured when they are admitted to the basic skills laboratory, 15 minutes after they are admitted to the laboratory, 30 minutes after they are admitted to the laboratory, 60 minutes after they are admitted to the laboratory and when they leave the laboratory, and their shivering level and temperature comfort perception will also be measured during these periods. In this form, the measurement times of body temperature values were determined based on the literature | 5 months | |
Primary | Descriptive Characteristics | Descriptive Characteristics Form: The form created by the researcher in line with the literature consists of questions about descriptive characteristics of the voluntueers | 5 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Not yet recruiting |
NCT05306392 -
Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation
|
N/A | |
Completed |
NCT02685176 -
Head and Torso Rewarming Using a Human Model for Severe Hypothermia
|
N/A | |
Withdrawn |
NCT02812069 -
WarmSmart Warming Protocol
|
N/A | |
Completed |
NCT02586974 -
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
|
N/A | |
Completed |
NCT02177903 -
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
|
N/A | |
Not yet recruiting |
NCT02211703 -
National Epidemiologic Survey on the Incidence of Perioperative Hypothermia
|
N/A | |
Completed |
NCT02121574 -
Accuracy of Zero-flux and Ingestible Thermometers
|
N/A | |
Completed |
NCT02742818 -
Forced-air Warming in Endovascular Surgery: Testing Effectiveness of Two Different Blanket Models
|
N/A | |
Recruiting |
NCT01866384 -
Targeted Temperature Management After Intracerebral Hemorrhage
|
Phase 2 | |
Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
Completed |
NCT01793337 -
Core Body Temperature Measurement During Hot and Cold Environmental Exposure
|
N/A | |
Completed |
NCT01722955 -
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
|
N/A | |
Completed |
NCT01559675 -
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
|
N/A | |
Terminated |
NCT01018576 -
Delayed Cord Clamping in Premature Infants
|
N/A | |
Completed |
NCT00904228 -
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
|
N/A | |
Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
Completed |
NCT00334360 -
Dexmed/Buspirone Synergism on Shivering
|
Phase 4 | |
Completed |
NCT04399902 -
Study to Actively Warm Trauma Patients
|
N/A | |
Completed |
NCT03450668 -
mOm Incubator Pilot Study
|
N/A |