Clinical trial NCT05887518: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Transurethral Resection
Wearable Devices
Venous Thromboembolism
Hypothermia
Nurse
Keywords: transurethral resection
Wearable devices
venous thromboembolism
hypothermia
nurse
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2023-06-02
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two-arm (1:1), randomised controlled, double-blind clinical trial
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Body temperature
timeFrame: Perioperative period
measure: Shivering level
timeFrame: Perioperative period
measure: Comfort perception
timeFrame: Perioperative period
Secondary outcomes:
measure: Development of venous thromboembolism
timeFrame: Perioperative period
measure: Descriptive Characteristics
timeFrame: Perioperative period
Other outcomes:
Locations:
Study officials:
affiliation: Mersin University
name: Gülay Altun Uğraş, Assoc. Dr.
role: STUDY_DIRECTOR
affiliation: Mersin University
name: Evren Değirmenci, Assoc.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Murat Bozlu, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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