The Effect of Sock Developed with Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism
NCT ID: NCT05887518
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-12-01
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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EXPERIMENTAL 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 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.
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.
CONTROL GROUP
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
ALL
Yes
Sponsors
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Mersin University
OTHER
Tarsus University
OTHER
Responsible Party
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Gamze BOZKUL
Principal Investigator
Principal Investigators
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Gülay Altun Uğraş, Assoc. Dr.
Role: STUDY_DIRECTOR
Mersin University
Evren Değirmenci, Assoc.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin University
Murat Bozlu, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin University
References
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Other Identifiers
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MU-BOZKUL-002
Identifier Type: -
Identifier Source: org_study_id
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