The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery

NCT06592807 | Completed

• 1 other identifier: 2023/262
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Surgery

Keywords

body temperature; perioperative; warm sock; hypothermia

Outcome Measures

Primary Outcomes (2)

• Tympanic temperature measurement

  It is the measurement of the patient's temperature via the tympanic route.

  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.

  It measured once at the 1st minute after surgery.

Secondary Outcomes (7)

• Subjectıve thermal comfort

  It measured at the 15th minutes after surgery.

• Visual analog scale: Pain

  It measured at the 15th minutes after surgery.

• Body temperature

  Measured every 15 minutes for the first hour after surgery.

• Pulse

  Measured every 15 minutes for the first hour after surgery.

• Spo2

  Measured every 15 minutes for the first hour after surgery.

Study Arms (2)

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.

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.

Interventions

Perioperative Warm Socks OTHER

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.

Warm Sock Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Hatice Merve Alptekin

Kocaeli, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 27783839 BACKGROUND

• Kim, J. S. (2004). Anesthesia and body temperature. Korean Journal of Anesthesiology, 47(5), 609-616.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21547171 BACKGROUND

• 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.

  PMID: 29396880 BACKGROUND

• 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.

  PMID: 21126665 BACKGROUND

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice Merve Alptekin, PhD

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers who collected data and analyzed the study results were different.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: July 18, 2023
• Primary Completion: July 18, 2023
• Study Completion: August 4, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

TU (1)