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NCT05887518 Clinical Trial

The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title:
The Effect of Sock Developed wıth Wearable Technology for Patıents Undergoıng Transurethral Resectıon Surgery on the Development of Hypothermıa and Venous Thromboembolısm

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05887518
Other study ID # MU-BOZKUL-002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date October 1, 2024

Study information
Verified date May 2024
Source Tarsus University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of the sock to be developed with wearable technology for patients who will undergo TUR surgery on the development of hypothermia and VTE. The population of the study will consist of patients who will undergo TUR surgery between 01 October 2023 and 01 October 2024. patients will be included in the study. The study was planned as a prospective, two-arm (1:1), randomised controlled, double-blind clinical trial. The data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form". The hypothermia follow-up form includes "Shivering Level Diagnosis Form" and "Temperature Comfort Perception Scale" The descriptive variables of the patients included in the study will be expressed as mean ± standard deviation and median (maximum-minimum), percentage and frequency. In data analysis; dependent and independent t test will be used when parametric test preconditions are met. 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 analyses as further analysis. Post hoc power analysis will be performed after the sample size reaches 70.

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Socks Developed with Wearable Technology
This new material will have the ability to prevent hypothermia by rewarming the patient when the body temperature drops below 360C and will reduce the risk of DVT that may develop in patients due to hypothermia. Thus, a single material will be used for two important complications of the surgical process, such as hypothermia and DVT, which negatively affect patient outcomes. This situation suggests that this material developed with an innovative approach will be more cost effective.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Tarsus University Mersin University

References & Publications (23)

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Outcome
Type Measure Description Time frame Safety issue
Primary Body temperature Hypothermia Monitoring Form: It is a form in which the body temperature, shivering level and temperature comfort perception of the patients and the time when the body temperature reached 360C in the postoperative period are recorded. Body temperature is recorded preoperatively (when the patient comes to the operating theatre preop preparation room, when the patient is taken to the operating room), intraoperatively (when anaesthesia is given, at the 30th and 60th minutes of the surgical intervention, at the end of the surgery). The level of shivering and temperature comfort perception will be measured preoperatively (when the patient comes to the operating theatre preop preparation room, when the patient is taken to the operating room) and postoperatively (when the patient comes to the recovery room, when the patient is transferred from the recovery room to the ward). Perioperative period
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. Perioperative period
Primary Comfort perception Temperature Comfort Perception Scale: It is a visual analogue scale developed by Wagner (2006) to provide objective assessment of temperature comfort perception. In the scale, the level of temperature comfort perception is evaluated between 0 (extremely cold) - 10 (extremely hot) according to the patient's report. Perioperative period
Secondary Development of venous thromboembolism Descriptive Characteristics Form: In the form prepared by the researchers in line with the literature, VTE development status will be questioned and recorded during hospitalisation. Perioperative period
Secondary Descriptive Characteristics Descriptive Characteristics Form: The form created by the researcher in line with the literature consists of questions about the age, gender, educational status of the patients and the characteristics of the procedure. Perioperative period
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