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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Hatice Merve Alptekin

    Kocaeli

Other trials in Turkey (Türkiye)

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 groups in NCT06592807
Study groupRoleWhat they receive
Warm Sock GroupExperimental1. 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 GroupNo intervention1. 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.

  1. 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)

  2. 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)
  1. 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.

  2. 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.

  3. 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.

  4. Pulse

    Measurements were made from the patients index finger with a pulse oximeter.

    Measured: Measured every 15 minutes for the first hour after surgery.

  5. Spo2

    Measurements were made from the patients index finger with a pulse oximeter.

    Measured: Measured every 15 minutes for the first hour after surgery.

  6. Respiration

    The patients breathing was counted for 1 minute.

    Measured: Measured every 15 minutes for the first hour after surgery

  7. 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.

  1. First posted19 Sep 2024
  2. Study start18 Jul 2023
  3. Primary completion18 Jul 2023
  4. Study completion4 Aug 2024

Resources

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)
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 27783839
  • Kim, 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 21547171
  • Lee 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 29396880
  • Hooper 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

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.

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