The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery

NCT06988696 | Recruiting

• 1 other identifier: Heated Sock
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of perioperative use of heated socks on the prevention of hypothermia and its impact on vital signs in patients undergoing bladder tumor surgery. It is anticipated that the data obtained from the study will provide evidence that the use of perioperative heated socks can help prevent hypothermia and positively influence vital signs in patients undergoing bladder tumor surgery.

Conditions

Bladder Tumor

Outcome Measures

Primary Outcomes (1)

• The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial

  IAs a result of the measurement in this study: Body temperature is measured tympanically. Hypothermia is generally classified based on cases where the body temperature falls below 35.0 °C. Hypothermia symptoms may vary as body temperature drops, so hypothermia is divided into three levels according to its severity.Body Temperature: Monitoring body temperature before and after surgery. Specifically, evaluating whether preoperative warm sock application helps maintain body temperature within normal ranges. Target Body Temperature: Assessing whether the targeted body temperature range (e.g., 36-37°C) for preventing hypothermia is achieved.

  40 weeks

Study Arms (2)

The Effect of Warm Sock Application on Hypothermia

EXPERIMENTAL

After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention. Eligible patients will be informed about the study by reading the voluntary informed consent form, which includes information about the purpose, content, and methodology of the research. Both verbal and written consent will be obtained from patients who agree to voluntarily participate in the study. Initially, the Descriptive Characteristics Form will be administered to the patients. One group will be given heated socks, one group will be given regular socks, and one group will not receive any intervention. The effect of these interventions on hypothermia will be examined.

Other: The Effect of Warm Sock Application on Hypothermia After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention.

The Effect of Warm Sock Application on Vital Signs

EXPERIMENTAL

After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention. Eligible patients will be informed about the study by reading the voluntary informed consent form, which includes information about the purpose, content, and methodology of the research. Both verbal and written consent will be obtained from patients who agree to voluntarily participate in the study. Initially, the Descriptive Characteristics Form will be administered to the patients. One group will be given heated socks, one group will be given regular socks, and one group will not receive any intervention. The effect of these interventions on vital signs will be examined.

Other: The Effect of Warm Sock Application on Hypothermia After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention.

Interventions

The Effect of Warm Sock Application on Hypothermia After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention. OTHER

The Effect of Warm Sock Application on Hypothermia After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention. Eligible patients will be informed about the study by reading the voluntary informed consent form, which includes information about the purpose, content, and methodology of the research. Both verbal and written consent will be obtained from patients who agree to voluntarily participate in the study. Initially, the Descriptive Characteristics Form will be administered to the patients. One group will be given heated socks, one group will be given regular socks, and one group will not receive any intervention. The effect of these interventions on hypothermia will be examined.

Also known as: The Effect of Warm Sock Application on Vital Signs After admission to the urology ward, patients who meet the sample selection criteria will be identified one day prior to the surgical intervention.

The Effect of Warm Sock Application on Hypothermia; The Effect of Warm Sock Application on Vital Signs

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The duration of surgical intervention is between 2 and 4 hours,
• Ability to read, write, understand and communicate in Turkish,
• Voluntary participation in the study,
• Does not require follow-up in intensive care before or after surgery,
• Dementia, alzheimer etc. absence of disease affecting cognitive functions,
• Absence of a disease that may affect thermoregulation due to systemic effects such as chronic obstructive pulmonary disease (COPD), cancer, intracranial benign/malignant tumor, epilepsy, multiple sclerosis, Parkinson's disease, and thyroid-related diseases,
• Absence of drug use that may affect thermoregulation,
• It is not uncomfortable to wear heat socks during application.

You may not qualify if:

• Mental retardation and the presence of any psychiatric disorder,
• Being addicted to alcohol and drugs,
• Dementia, alzheimer etc. have a disease that affects cognitive functions,
• Having drug use that may affect thermoregulation,
• Discomfort from wearing heat socks during application,
• Having any disease that affects tissue perfusion,
• Presence of any peripheral arterial and venous disease,
• The need for intensive care before or after surgery

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Seval Ulubay

Samsun, Atakum/Samsun, 55200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Lauronen SL, Kalliomaki ML, Aho AJ, Kalliovalkama J, Riikonen JM, Makinen MT, Leppikangas HM, Yli-Hankala AM. Thermal suit in preventing unintentional intraoperative hypothermia during general anaesthesia: a randomized controlled trial. Acta Anaesthesiol Scand. 2017 Oct;61(9):1133-1141. doi: 10.1111/aas.12945. Epub 2017 Jul 25.

  PMID: 28741744 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• SEVAL ULUBAY, PHD

  SAMSUN GAZI STATE HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEVAL ULUBAY, PHD

CONTACT

+905424300793; sevalulubay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 25, 2025
• Study Start: November 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 30, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: August 2025-march 2026
• Access Criteria: sevalulubay@gmail.com

Locations

TU (1)