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

NCT06283771 | Not Yet Recruiting

• 1 other identifier: TU-BOZKUL-007
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Wearable Technology; Hypothermia; Shivering; Thermal Comfort Perception

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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

Other: Heated socks to be developed with wearable technology

CONTROL GROUP

NO INTERVENTION

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.

Interventions

Heated socks to be developed with wearable technology OTHER

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

EXPERIMENTAL GROUP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tarsus University: lead
• Mersin University: collaborator

Related Publications (6)

• 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.

  PMID: 30363722 BACKGROUND

• 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.

  PMID: 18927450 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33664502 BACKGROUND

• 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.

  PMID: 28850551 BACKGROUND

• 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.

  PMID: 26924539 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Gamze Bozkul

  Tarsus University

  PRINCIPAL INVESTIGATOR

• Evren Değirmenci

  Mersin University

  PRINCIPAL INVESTIGATOR

• Murat BOZLU

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülay Altun UĞRAŞ

CONTACT

0-324-3610001; gulay.altun@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share