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

Primary Purpose

Transurethral Resection, Wearable Devices, Venous Thromboembolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Socks Developed with Wearable Technology
Sponsored by
Tarsus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transurethral Resection focused on measuring transurethral resection, Wearable devices, venous thromboembolism, hypothermia, nurse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written and verbal permission to participate in the study was obtained, Conscious, orientated and co-operative, Who speaks and understands Turkish, Undergoing TUR surgery, Not hypothermic in the preoperative period, No peripheral vascular disease, Not allergic to sock material, Patients without devices that send electric current into the body (pacemaker, etc.) Exclusion Criteria: Written and verbal permission to participate in the research could not be obtained, Unconscious, disorientated and uncooperative, Speaking Turkish and not understanding it, No TUR surgery, Hypothermic in the pre-operative period, With peripheral vascular disease, Allergic to sock material Patients with devices that send electric current into the body (pacemaker, etc.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    EXPERIMENTAL GROUP

    CONTROL GROUP

    Arm Description

    In addition to the routine treatment and care practices of the operating theatre, the patients included in the study group will wear antiembolytic socks and warming socks to be developed with wearable technology. After the antiembolitic socks are put on the patients in the ward, the socks to be developed with wearable technology will be put on the study group before they are sent to the operating theatre and will be removed one day after the operation. The socks to be used in the research (heating socks developed with wearable technology will be developed by the researchers and patent application will be made. The application of socks to be developed with wearable technology in the research will be applied to all patients by the same executive. Verbal and written consent will be obtained from the patient/relative before the start of the study.

    In the control group, the same looking sock will be worn before the patient is sent to the operating theatre and will be removed one day after the operation. The sock to be used in the research will be developed by the researchers and a patent application will be made. Verbal and written consent will be obtained from the patient/relative before the start of the study. The data obtained from the patients will be recorded in the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before the TUR. The application of socks to be developed with wearable technology will be carried out in accordance with the following application steps.

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    May 7, 2023
    Last Updated
    October 21, 2023
    Sponsor
    Tarsus University
    Collaborators
    Mersin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887518
    Brief Title
    The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism
    Official Title
    The Effect of Sock Developed wıth Wearable Technology for Patıents Undergoıng Transurethral Resectıon Surgery on the Development of Hypothermıa and Venous Thromboembolısm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tarsus University
    Collaborators
    Mersin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    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 01October 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" .Control group: Patients will be fitted with antiembolitic socks in the ward, and the control group will be fitted with the same looking socks developed before the patient is sent to the operating theatre and will be removed one day after the operation. In the study, the same-looking socks will be applied to all patients by the same coordinator. Verbal and written permission will be obtained from the patient/relative before the study is started. The data obtained from the patients will be recorded in the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form" before TUR. Study group: In addition to the routine treatment and care practices of the operating theatre, the patients included in the study group will wear antiembolytic socks and a heater sock to be developed with wearable technology. After the patients are fitted with antiembolitic socks in the ward, the socks to be developed with wearable technology will be fitted to the study group before the patient is sent to the operating theatre and will be removed one day after the operation. The socks to be used in the research (socks with the same appearance as the heating socks developed with wearable technology) will be developed by the researchers and a patent application will be made. The socks to be developed with wearable technology in the study will be applied to all patients by the same responsible researcher. Verbal and written consent will be obtained from the patient/relative before the start of the study. The data obtained from the patients will be recorded in the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form" before TUR. The "Hypothermia Monitoring Form" will be filled in when the patients' vital signs are taken into the operating room, after anaesthesia is given, at the 15th, 30th and 60th minutes of the surgical procedure, at the end of the surgical procedure, when they come to the recovery room, and when they are transferred from the recovery room to the ward.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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transurethral Resection, Wearable Devices, Venous Thromboembolism, Hypothermia, Nurse
    Keywords
    transurethral resection, Wearable devices, venous thromboembolism, hypothermia, nurse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, two-arm (1:1), randomised controlled, double-blind clinical trial
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    A total of 70 patients in the sample group determined by randomisation will be divided according to the A and B groups formed by the same statistician in the computer environment. The information that the patients included in the research sample were assigned to group A and B according to the randomisation table will be kept by the consultant, and the socks with and without heating feature will be numbered from 1 to 70 according to the randomisation table and given to the practitioner so that the practitioner will be blinded when he/she does not know which sock has heating feature and which one does not. Thus, patients will be blinded as they do not know which group they are in.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EXPERIMENTAL GROUP
    Arm Type
    Experimental
    Arm Description
    In addition to the routine treatment and care practices of the operating theatre, the patients included in the study group will wear antiembolytic socks and warming socks to be developed with wearable technology. After the antiembolitic socks are put on the patients in the ward, the socks to be developed with wearable technology will be put on the study group before they are sent to the operating theatre and will be removed one day after the operation. The socks to be used in the research (heating socks developed with wearable technology will be developed by the researchers and patent application will be made. The application of socks to be developed with wearable technology in the research will be applied to all patients by the same executive. Verbal and written consent will be obtained from the patient/relative before the start of the study.
    Arm Title
    CONTROL GROUP
    Arm Type
    No Intervention
    Arm Description
    In the control group, the same looking sock will be worn before the patient is sent to the operating theatre and will be removed one day after the operation. The sock to be used in the research will be developed by the researchers and a patent application will be made. Verbal and written consent will be obtained from the patient/relative before the start of the study. The data obtained from the patients will be recorded in the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before the TUR. The application of socks to be developed with wearable technology will be carried out in accordance with the following application steps.
    Intervention Type
    Device
    Intervention Name(s)
    Socks Developed with Wearable Technology
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body temperature
    Description
    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).
    Time Frame
    Perioperative period
    Title
    Shivering level
    Description
    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.
    Time Frame
    Perioperative period
    Title
    Comfort perception
    Description
    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.
    Time Frame
    Perioperative period
    Secondary Outcome Measure Information:
    Title
    Development of venous thromboembolism
    Description
    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.
    Time Frame
    Perioperative period
    Title
    Descriptive Characteristics
    Description
    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.
    Time Frame
    Perioperative period

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written and verbal permission to participate in the study was obtained, Conscious, orientated and co-operative, Who speaks and understands Turkish, Undergoing TUR surgery, Not hypothermic in the preoperative period, No peripheral vascular disease, Not allergic to sock material, Patients without devices that send electric current into the body (pacemaker, etc.) Exclusion Criteria: Written and verbal permission to participate in the research could not be obtained, Unconscious, disorientated and uncooperative, Speaking Turkish and not understanding it, No TUR surgery, Hypothermic in the pre-operative period, With peripheral vascular disease, Allergic to sock material Patients with devices that send electric current into the body (pacemaker, etc.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gamze Bozkul, Res. Ass.
    Phone
    (0324) 600 00 33
    Email
    gamze.bozkul@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gülay ALTUN UĞRAŞ, Assoc.Dr.
    Phone
    0-324-3610001
    Email
    gulaltun@mersin.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gülay Altun Uğraş, Assoc. Dr.
    Organizational Affiliation
    Mersin University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Evren Değirmenci, Assoc.Dr.
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Murat Bozlu, Prof. Dr.
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    All datasets will support enriched data to be available and accessible online. Aperta Turkey Open Archive is a platform where data uploads are made by researchers, called a data repository, which can be used free of charge and provides data management, protection and storage. Since publications will be obtained from these data produced during the project, it is planned to be shared in APERTA, the Open Archive of TÜBİTAK, in line with FAIR principles (findable, accessible, interoperable, reusable) and the data will be reused for new research
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    The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism

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