Spinal SurgeryNCT06592807
The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery
A study testing Perioperative Warm Socks in people with Spinal Surgery, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
It is important to maintain the body temperature of patients during spine surgery because hypothermia that occurs during surgery can increase the risk of complications and negatively affect the recovery process. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- Perioperative Warm Socks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2023to 4 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must be between 18-64 years old
- Able to understand and speak Turkish
- In the ASA1,2,3 class according to the ASA classification
- Not have anemia, coagulation problems, peripheral circulation disorders or a metabolic disease
- Willing to undergo spine surgery (LDH,SDH, scoliosis, stabilization)
- Not undergoing spinal and local anesthesia
- Volunteering to participate in the study
Who cannot join
- The patient's surgery lasting less than 2 hours or more than 5 hours
- The patient's socks are removed during the surgery
- The patient's tympanic body temperature is not checked during the surgery
- Complications develop during and after the surgery
- The patient is taken to intensive care immediately after the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery: Randomized Controlled Trial
It is important to maintain the body temperature of patients during spine surgery because hypothermia that occurs during surgery can increase the risk of complications and negatively affect the recovery process. For this reason, various methods are being investigated to maintain the body temperature of patients during and after surgery. Warm socks application is a simple and effective method performed by putting warm socks on the feet of patients. This application has been shown to better maintain the body temperature of patients during the perioperative period and may reduce the incidence of hypothermia. Warm socks help maintain body temperature by increasing blood circulation and reducing heat loss. As a result, warm socking application is considered a useful and recommended method for maintaining body temperature in patients undergoing surgery.
Read the detailed description
Hypothermia during surgery is a common problem among patients undergoing surgery. It is known that approximately half of the patients who undergo surgery develop hypothermia. Hypothermia is defined as a central temperature below 36°C. The body temperature of patients decreases during the first hour of general anesthesia and continues to decrease when the surgery exceeds 2 hours. In the event of hypothermia, the patient develops a physiological shivering response. It can also increase patients oxygen consumption by up to 40%. Active and passive heating methods are used to prevent this. Warm socks are one of the passive heating methods.
In the preoperative period, putting pre-warmed socks on patients is effective in maintaining core body temperature, controlling shivering response and ensuring thermal comfort of patients. Pre-warmed socks are a noninvasive, easy-to-wear, painless and cost-effective method to prevent body temperature loss. The application of warm socks is also a method that allows the patient position to be changed and surgical preparation, is comfortable for the patient, reduces preoperative anxiety and can be applied without a physician order.
Study Population and Sampling: The universe of the study will consist of patients who underwent spinal surgery in the Operating Room of Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Nervous Diseases Education and Research Hospital on the specified dates.
Sample: In the study, Gpower was used to determine the effect of perioperative warm socks application on maintaining body temperature in patients undergoing spinal surgery. The study findings reported by Lee et al. were used to determine the d value, which is the effect size index. It was calculated as α= 0.05, power=0.80 d=0.63. The sample was determined as 32 people for each group, a total of 64 patients.
Randomization: The research was conducted as double blind randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously.
For this purpose, 64 sets were created by using the functions on the internet address ;https://www.random.org/integer-sets; and each of these sets included 8 subjects, 4 subjects from each study group. As the next process, 64 sets were shown with 1 number each, 8 numbers between 1 and 64 were generated using the ;RANDOMLY SEARCH; function in Excel, and 8 sets to be used in randomization were randomly determined. Each set will contain 8 (4 experimental, 4 control) patients.
Data Collection Method: Data were collected by the researcher using face-to-face interview technique.
Data Collection Tools:
Personal information form (sociodemographic characteristics): This form, prepared by the researcher in line with the literature, aims to obtain information about the participants; sociodemographic characteristics (gender, age, occupation, etc.) and the surgery (duration of the surgery, start and end time of the surgery, etc.).
Tympanic temperature table: It was measured just before the surgery and continued to be measured every half hour throughout the surgery.
Operating room temperature table: It was measured just before the surgery and continued to be measured every half hour throughout the surgery.
Shivering scale: To determine the degree of the patients shiver, the researcher observed the patient. Then, patient gave a score between 0 and 4 to rate. 0: No signs of shiver. 4: Mean teeth chattering shiver. Measured after surgery.
Subjectıve thermal comfort scale: The patient was asked to determine the temperature he felt. It was evaluated between 1 and 6. 1: very cold, 6: very hot. It was measured after the surgery.
Vital signs: Body temperature, pulse, respiration, blood pressure, and SpO2 values were measured every 15 minutes for the first hour after surgery.
Visual analog scale: The two extreme definitions of the parameter to be evaluated are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her own condition fits on this line by drawing a line, putting a dot, or marking. For example, for pain, I have no pain at one end, and very severe pain is written at the other end, and the patient marks his/her current condition on this line. The length of the distance from the place where there is no pain to the point marked by the patient indicates the patients pain.
- Conditions
- Spinal Surgery
- Being tested
- Perioperative Warm Socks
- Keywords
- body temperature, perioperative, warm sock, hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Warm SocksOther
The socks to be used in the study were provided by the researcher. The socks were suitable for foot sizes 36-45. The socks were white and made of cotton fabric. The socks were sterilized in an autoclave before use. The socks were put on the patients just before the surgery. The socks were heated to 40 degrees with an intravenous fluid warming machine.The socks remained on the patients feet throughout the surgery. After the surgery, the patients socks were removed and new heated socks were put on. The socks were kept on the patients feet for 1 hour. All socks were used for single use.
| Study group | Role | What they receive |
|---|---|---|
| Warm Sock Group | Experimental | 1. Before surgery, patients are informed about the study and their tympanic body temperatures are measured.
2. The socks that the patient will wear during the surgery are warmed and put on.
3. During the surgery, the operating room temperature is measured and recorded. The patient's tympanic body temperature is also measured and recorded. (Every half hour).
4. When the patient is taken to the postoperative care unit, the socks are changed to new heated socks.
5. After the surgery, patients are given a survey question regarding socio-demographic data. Patients' pain is assessed with VAS (visual analog scale). Patients' thermal comfort is assessed. Patients' shivering is assessed according to the shivering scale. In addition, patients' vital signs are assessed every 15 minutes for one hour. Receives: Other: Perioperative Warm Socks |
| Control Group | No intervention | 1. Before surgery, patients are informed about the study and their tympanic body temperatures are measured. 2. During the surgery, the operating room temperature is measured and recorded. The patient's tympanic body temperature is also measured and recorded. (Every half hour). 3. After the surgery, patients are given a survey question regarding socio-demographic data. Patients' pain is assessed with VAS (visual analog scale). Patients' thermal comfort is assessed. Patients' shivering is assessed according to the shivering scale. In addition, patients' vital signs are assessed every 15 minutes for one hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic temperature measurement
It is the measurement of the patient's temperature via the tympanic route.
Measured: Every half hour during the surgery. (Until the 5th hour)
Shivering
To determine the degree of the patient shiver, the researcher observed the patient. Then, patient gave a score between 0 and 4 to rate. 0: No signs of shiver. 4: Mean teeth chattering shiver.
Measured: It measured once at the 1st minute after surgery.
Secondary outcomes (7)
Subjectıve thermal comfort
The patients were asked to determine the temperature they felt. It was evaluated between 1 and 6. 1: very cold, 6: very hot.
Measured: It measured at the 15th minutes after surgery.
Visual analog scale: Pain
The two extreme definitions of the parameter to be evaluated are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her own condition fits on this line by drawing a line, putting a dot, or marking. For example, for pain, I have no pain at one end, and very severe pain is written at the other end, and the patient marks his/her current condition on this line. The length of the distance from the place where there is no pain to the point marked by the patient indicates the patients pain.
Measured: It measured at the 15th minutes after surgery.
Body temperature
It is the measurement of the patients temperature via the tympanic route
Measured: Measured every 15 minutes for the first hour after surgery.
Pulse
Measurements were made from the patients index finger with a pulse oximeter.
Measured: Measured every 15 minutes for the first hour after surgery.
Spo2
Measurements were made from the patients index finger with a pulse oximeter.
Measured: Measured every 15 minutes for the first hour after surgery.
Respiration
The patients breathing was counted for 1 minute.
Measured: Measured every 15 minutes for the first hour after surgery
Blood pressure
The patient was monitored by placing a cuff on patients arm to measure his blood pressure.
Measured: Measured every 15 minutes for the first hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Jul 2023
- Primary completion18 Jul 2023
- Study completion4 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Merve Alptekin, Kocaeli University
- Investigators
- Hatice Merve Alptekin, PhD, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592807
- Sponsor's protocol ID
- 2023/262
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frisch NB, Pepper AM, Rooney E, Silverton C. Intraoperative Hypothermia in Total Hip and Knee Arthroplasty. Orthopedics. 2017 Jan 1;40(1):56-63. doi: 10.3928/01477447-20161017-04. Epub 2016 Oct 27.
PubMed 27783839Kim, J. S. (2004). Anesthesia and body temperature. Korean Journal of Anesthesiology, 47(5), 609-616.
Collins, V. J. (1996). Temperature regulation and heat problems. In V. J. Collins (Ed.), Physiologic and pharmacologic bases of anesthesia (pp. 316-344). Baltimore, MD: Williams & Wilkins.
Shakya S, Chaturvedi A, Sah BP. Prophylactic low dose ketamine and ondansetron for prevention of shivering during spinal anaesthesia. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):465-9.
PubMed 21547171Lee HY, Kim G, Shin Y. Effects of perioperative warm socks-wearing in maintaining core body temperature of patients undergoing spinal surgery. J Clin Nurs. 2018 Apr;27(7-8):1399-1407. doi: 10.1111/jocn.14284. Epub 2018 Mar 26.
PubMed 29396880Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
PubMed 21126665
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06592807
- Acronym / sponsor ID
- 2023/262
- Conditions
- Spinal Surgery
- Keywords
- body temperature, perioperative, warm sock, hypothermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 4 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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.
It is important to maintain the body temperature of patients during spine surgery because hypothermia that occurs during surgery can increase the risk of complications and negatively affect the recovery process. For this reason, various methods are being investigated to maintain the body temperature of patients during and after surgery. Warm socks application is a simple and effective method performed by putting warm socks on the feet of patients. This application has been shown to better maintain the body temperature of patients during the perioperative period and may reduce the incidence of hypothermia. Warm socks help maintain body temperature by increasing blood circulation and reducing heat loss. As a result, warm socking application is considered a useful and recommended method for maintaining body temperature in patients undergoing surgery.
Detailed description
Hypothermia during surgery is a common problem among patients undergoing surgery. It is known that approximately half of the patients who undergo surgery develop hypothermia. Hypothermia is defined as a central temperature below 36°C. The body temperature of patients decreases during the first hour of general anesthesia and continues to decrease when the surgery exceeds 2 hours. In the event of hypothermia, the patient develops a physiological shivering response. It can also increase patients oxygen consumption by up to 40%. Active and passive heating methods are used to prevent this. Warm socks are one of the passive heating methods.
In the preoperative period, putting pre-warmed socks on patients is effective in maintaining core body temperature, controlling shivering response and ensuring thermal comfort of patients. Pre-warmed socks are a noninvasive, easy-to-wear, painless and cost-effective method to prevent body temperature loss. The application of warm socks is also a method that allows the patient position to be changed and surgical preparation, is comfortable for the patient, reduces preoperative anxiety and can be applied without a physician order.
Study Population and Sampling: The universe of the study will consist of patients who underwent spinal surgery in the Operating Room of Istanbul Bakırköy Prof. Dr. Mazhar Osman Mental Health and Nervous Diseases Education and Research Hospital on the specified dates.
Sample: In the study, Gpower was used to determine the effect of perioperative warm socks application on maintaining body temperature in patients undergoing spinal surgery. The study findings reported by Lee et al. were used to determine the d value, which is the effect size index. It was calculated as α= 0.05, power=0.80 d=0.63. The sample was determined as 32 people for each group, a total of 64 patients.
Randomization: The research was conducted as double blind randomized and controlled experimental study. A simple computer-assisted randomization method was used to distribute the groups homogeneously.
For this purpose, 64 sets were created by using the functions on the internet address ;https://www.random.org/integer-sets; and each of these sets included 8 subjects, 4 subjects from each study group. As the next process, 64 sets were shown with 1 number each, 8 numbers between 1 and 64 were generated using the ;RANDOMLY SEARCH; function in Excel, and 8 sets to be used in randomization were randomly determined. Each set will contain 8 (4 experimental, 4 control) patients.
Data Collection Method: Data were collected by the researcher using face-to-face interview technique.
Data Collection Tools:
Personal information form (sociodemographic characteristics): This form, prepared by the researcher in line with the literature, aims to obtain information about the participants; sociodemographic characteristics (gender, age, occupation, etc.) and the surgery (duration of the surgery, start and end time of the surgery, etc.).
Tympanic temperature table: It was measured just before the surgery and continued to be measured every half hour throughout the surgery.
Operating room temperature table: It was measured just before the surgery and continued to be measured every half hour throughout the surgery.
Shivering scale: To determine the degree of the patients shiver, the researcher observed the patient. Then, patient gave a score between 0 and 4 to rate. 0: No signs of shiver. 4: Mean teeth chattering shiver. Measured after surgery.
Subjectıve thermal comfort scale: The patient was asked to determine the temperature he felt. It was evaluated between 1 and 6. 1: very cold, 6: very hot. It was measured after the surgery.
Vital signs: Body temperature, pulse, respiration, blood pressure, and SpO2 values were measured every 15 minutes for the first hour after surgery.
Visual analog scale: The two extreme definitions of the parameter to be evaluated are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her own condition fits on this line by drawing a line, putting a dot, or marking. For example, for pain, I have no pain at one end, and very severe pain is written at the other end, and the patient marks his/her current condition on this line. The length of the distance from the place where there is no pain to the point marked by the patient indicates the patients pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm Sock Group | Experimental | Other: Perioperative Warm Socks1. Before surgery, patients are informed about the study and their tympanic body temperatures are measured. 2. The socks that the patient will wear during the surgery are warmed and put on. 3. During the surgery, the operating room temperature is measured and recorded. The patient's tympanic body temperature is also measured and recorded. (Every half hour). 4. When the patient is taken to the postoperative care unit, the socks are changed to new heated socks. 5. After the surgery, patients are given a survey question regarding socio-demographic data. Patients' pain is assessed with VAS (visual analog scale). Patients' thermal comfort is assessed. Patients' shivering is assessed according to the shivering scale. In addition, patients' vital signs are assessed every 15 minutes for one hour. |
| Control Group | No intervention | –1. Before surgery, patients are informed about the study and their tympanic body temperatures are measured. 2. During the surgery, the operating room temperature is measured and recorded. The patient's tympanic body temperature is also measured and recorded. (Every half hour). 3. After the surgery, patients are given a survey question regarding socio-demographic data. Patients' pain is assessed with VAS (visual analog scale). Patients' thermal comfort is assessed. Patients' shivering is assessed according to the shivering scale. In addition, patients' vital signs are assessed every 15 minutes for one hour. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The patient must be between 18-64 years old
- Able to understand and speak Turkish
- In the ASA1,2,3 class according to the ASA classification
- Not have anemia, coagulation problems, peripheral circulation disorders or a metabolic disease
- Willing to undergo spine surgery (LDH,SDH, scoliosis, stabilization)
Key exclusion criteria (5 listed)
- The patient's surgery lasting less than 2 hours or more than 5 hours
- The patient's socks are removed during the surgery
- The patient's tympanic body temperature is not checked during the surgery
- Complications develop during and after the surgery
- The patient is taken to intensive care immediately after the surgery
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 |
|---|---|---|
| Perioperative Warm SocksThe socks to be used in the study were provided by the researcher. The socks were suitable for foot sizes 36-45. The socks were white and made of cotton fabric. The socks were sterilized in an autoclave before use. The socks were put on the patients just before the surgery. The socks were heated to 40 degrees with an intravenous fluid warming machine.The socks remained on the patients feet throughout the surgery. After the surgery, the patients socks were removed and new heated socks were put on. The socks were kept on the patients feet for 1 hour. All socks were used for single use. | Other | Warm Sock Group |
Primary outcome
Tympanic temperature measurement
Time frame: Every half hour during the surgery. (Until the 5th hour)
It is the measurement of the patient's temperature via the tympanic route.
Shivering
Time frame: It measured once at the 1st minute after surgery.
To determine the degree of the patient shiver, the researcher observed the patient. Then, patient gave a score between 0 and 4 to rate. 0: No signs of shiver. 4: Mean teeth chattering shiver.
7 secondary outcomes
Subjectıve thermal comfort
Time frame: It measured at the 15th minutes after surgery.
Visual analog scale: Pain
Time frame: It measured at the 15th minutes after surgery.
Body temperature
Time frame: Measured every 15 minutes for the first hour after surgery.
Pulse
Time frame: Measured every 15 minutes for the first hour after surgery.
Spo2
Time frame: Measured every 15 minutes for the first hour after surgery.
Respiration
Time frame: Measured every 15 minutes for the first hour after surgery
Blood pressure
Time frame: Measured every 15 minutes for the first hour after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 27783839Frisch NB, Pepper AM, Rooney E, Silverton C. Intraoperative Hypothermia in Total Hip and Knee Arthroplasty. Orthopedics. 2017 Jan 1;40(1):56-63. doi: 10.3928/01477447-20161017-04. Epub 2016 Oct 27.
- BackgroundKim, J. S. (2004). Anesthesia and body temperature. Korean Journal of Anesthesiology, 47(5), 609-616.
- BackgroundCollins, V. J. (1996). Temperature regulation and heat problems. In V. J. Collins (Ed.), Physiologic and pharmacologic bases of anesthesia (pp. 316-344). Baltimore, MD: Williams & Wilkins.
- Background: PubMed 21547171Shakya S, Chaturvedi A, Sah BP. Prophylactic low dose ketamine and ondansetron for prevention of shivering during spinal anaesthesia. J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):465-9.
- Background: PubMed 29396880Lee HY, Kim G, Shin Y. Effects of perioperative warm socks-wearing in maintaining core body temperature of patients undergoing spinal surgery. J Clin Nurs. 2018 Apr;27(7-8):1399-1407. doi: 10.1111/jocn.14284. Epub 2018 Mar 26.
- Background: PubMed 21126665Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
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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. This study is not recruiting at the moment.
Hatice Merve Alptekin, PhD principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Warm Socks in people with Spinal Surgery, run by Kocaeli University 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanic temperature measurement (time frame: Every half hour during the surgery. (Until the 5th hour)). The study lists 2 primary outcomes in all. 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 NCT06592807, which also lists 6 linked publications.
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 10 Mar 2025.