Bladder TumorNCT06988696
The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery
A study testing 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. in people with Bladder Tumor, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Bladder Tumor
- What is being tested?
- 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Seval Ulubay
Samsun, Atakum/Samsun, 55200
seval ulubay, +905424300793 ext. +905424300793, sevalulubay@gmail.com
mehmet ulubay, DR, +905457815561 ext. +905424300793, sevalygz@gmail.com
About this study
Official title: The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial
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.
Read the detailed description
Bladder cancer accounts for 2-3% of all malignant tumors and constitutes 6-8% of all malignancies in men and 2-3% in women. Globally, it ranks as the seventh most common cancer in men and the seventeenth in women. Bladder cancer is a significant cause of morbidity and mortality worldwide, with approximately 350,000 new cases and 150,000 deaths annually. At the time of initial diagnosis, around 75% of patients with bladder tumors are diagnosed with non-muscle-invasive bladder cancer. Of those with muscle-invasive bladder cancer, 20% are cases that have progressed from lower-stage disease. If left untreated, approximately 85% of patients with muscle-invasive bladder cancer will die from the disease . For invasive bladder tumors, the gold standard treatment is radical cystectomy. Radical cystectomy combined with pelvic lymph node dissection provides the best disease-specific survival in patients with invasive bladder tumors . Following radical cystectomy, the average 10-year disease-free survival rate is approximately 50-66%.
During the surgical process, heat loss may occur due to the evaporation of cold solutions or through perspiration. Additional factors contributing to heat loss include the patient's exposure to the operating room environment without clothing, radiation exposure, and conduction due to contact with cold materials or the stretcher. Furthermore, preoperative hypothermia, fasting, and fluid deprivation; exposure of large body surface areas during surgery; use of volatile solutions for skin preparation; evaporation of cold solutions; perspiration; major open cavity surgical interventions; administration of cold IV fluids; prolonged surgical duration and exposure to anesthesia; intraoperative blood loss; peripheral vasodilation; anesthetic drugs; absence of clothing in the operating room; radiation; contact with cold materials or the stretcher; and impaired normal thermoregulation are all factors that may contribute to hypothermia.
- Conditions
- Bladder Tumor
- Being tested
- 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.
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Nov 2024
- Primary completion15 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder TumorStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Ulubay, Istanbul University - Cerrahpasa
- Investigators
- SEVAL ULUBAY, PHD, Principal investigator, Gazi State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988696
- Sponsor's protocol ID
- Heated Sock
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the approval of the board, heated socks to be used in my thesis work were obtained. Permission was granted by Samsun Gazi State Hospital, where the research would be conducted. Ethics Committee Approval was obtained from Samsun Health Sciences University Samsun Training and Research Hospital. The groups were determined through randomization over a pre-calculated sample. The pilot study is planned to begin after the randomization, and following the pilot study, necessary corrections will be made before proceeding to the data collection phase.
Publications
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.
PubMed 28741744
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06988696
- Acronym / sponsor ID
- Heated Sock
- Conditions
- Bladder Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bladder cancer accounts for 2-3% of all malignant tumors and constitutes 6-8% of all malignancies in men and 2-3% in women. Globally, it ranks as the seventh most common cancer in men and the seventeenth in women. Bladder cancer is a significant cause of morbidity and mortality worldwide, with approximately 350,000 new cases and 150,000 deaths annually. At the time of initial diagnosis, around 75% of patients with bladder tumors are diagnosed with non-muscle-invasive bladder cancer. Of those with muscle-invasive bladder cancer, 20% are cases that have progressed from lower-stage disease. If left untreated, approximately 85% of patients with muscle-invasive bladder cancer will die from the disease . For invasive bladder tumors, the gold standard treatment is radical cystectomy. Radical cystectomy combined with pelvic lymph node dissection provides the best disease-specific survival in patients with invasive bladder tumors . Following radical cystectomy, the average 10-year disease-free survival rate is approximately 50-66%.
During the surgical process, heat loss may occur due to the evaporation of cold solutions or through perspiration. Additional factors contributing to heat loss include the patient's exposure to the operating room environment without clothing, radiation exposure, and conduction due to contact with cold materials or the stretcher. Furthermore, preoperative hypothermia, fasting, and fluid deprivation; exposure of large body surface areas during surgery; use of volatile solutions for skin preparation; evaporation of cold solutions; perspiration; major open cavity surgical interventions; administration of cold IV fluids; prolonged surgical duration and exposure to anesthesia; intraoperative blood loss; peripheral vasodilation; anesthetic drugs; absence of clothing in the operating room; radiation; contact with cold materials or the stretcher; and impaired normal thermoregulation are all factors that may contribute to hypothermia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Effect of Warm Sock Application on Hypothermia | Experimental | 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.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. |
| The Effect of Warm Sock Application on Vital Signs | Experimental | 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.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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.Also: 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 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, The Effect of Warm Sock Application on Vital Signs |
Primary outcome
The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial
Time frame: 40 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 28741744Lauronen 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.
- Individual participant dataSharing planned: Yes. After the approval of the board, heated socks to be used in my thesis work were obtained. Permission was granted by Samsun Gazi State Hospital, where the research would be conducted. Ethics Committee Approval was obtained from Samsun Health Sciences University Samsun Training and Research Hospital. The groups were determined through randomization over a pre-calculated sample. The pilot study is planned to begin after the randomization, and following the pilot study, necessary corrections will be made before proceeding to the data collection phase.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEVAL ULUBAY, PHD principal investigator
Gazi State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Bladder Tumor, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVAL ULUBAY, PHD (+905424300793, sevalulubay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Perioperative Heated Sock Application on Hypothermia and Vital Signs in Bladder Tumor Surgery:A Randomized Controlled Trial (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.