The Effect of Perioperative Heated Sock Use in Preventing Hypothermia During Total Hip Prosthesis Surgery

NCT06541054 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Warm sock application; It has been proven that wearing battery-operated warm socks on patients in the preoperative period strengthens the central thermoregulation system, maintains core body temperature, controls the shivering response, and ensures the subjective thermal comfort of patients.

Conditions

Hip Fractures; Hip Injuries

Outcome Measures

Primary Outcomes (1)

• The Effect of Perioperative Heated Sock Use in Preventing Hypothermia During Total Hip Prosthesis Surgery: A Randomized Controlled Trial

  As 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.

  36 weeks

Study Arms (2)

control group

NO INTERVENTION

Body temperature, pulse, arterial blood pressure, SPO2 will be measured and recorded every fifteen minutes in the control group one hour before the operation. The patients in the control group will not be dressed in warm socks and general preparations will be made. During the operation, the patient's body temperature, pulse, arterial blood pressure, SPO2 values will be monitored every fifteen minutes and the total amount of drainage during the operation will be recorded in the same department. Body temperature, pulse, arterial blood pressure, SPO2 values, tremors, and total drainage in the postoperative care unit will be recorded every fifteen minutes. Body temperature, heart rate, arterial blood pressure, SPO2 values will be measured after transferring to the bed and every fifteen minutes for a total of 180 minutes, chills, shivering states, and 24-hour total drainage amount will be recorded in the same section.

experiment group

EXPERIMENTAL

One hour before the operation,warm socks will be put on the experimental group,body temperature,heart rate,blood pressure,SPO2 will be measured and recorded every fifteen minutes.During the surgery,body temperature,heart rate,blood pressure,SPO2 value, drainage amount will be measured and recorded every fifteen minutes.The patient will be transferred to the postoperative care unit with warm socks and will stay on his feet in the postoperative care unit.Body temperature, heart rate,blood pressure,SPO2 values will be recorded every fifteen minutes.He will be transferred from the postoperative care unit to the clinic with socks.will stay. After transferring to the bed,body temperature,heart rate, arterial blood pressure, SPO2 will be recorded every fifteen minutes for a total of 180minutes.Chills,chills and the total drainage amount for 24hours will be recorded in the same section.

Other: WARM SOCKS

Interventions

WARM SOCKS OTHER

One hour before the operation,warm socks will be put on the experimental group,body temperature,heart rate,blood pressure,SPO2 will be measured and recorded every fifteen minutes.During the surgery,body temperature,heart rate,blood pressure,SPO2 value, drainage amount will be measured and recorded every fifteen minutes.The patient will be transferred to the postoperative care unit with warm socks and will stay on his feet in the postoperative care unit.Body temperature, heart rate,blood pressure,SPO2 values will be recorded every fifteen minutes.He will be transferred from the postoperative care unit to the clinic with socks.will stay. After transferring to the bed,body temperature,heart rate, arterial blood pressure, SPO2 will be recorded every fifteen minutes for a total of 180minutes.Chills,chills and the total drainage amount for 24hours will be recorded in the same section.

experiment group

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)

Location

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 RESULT

MeSH Terms

Conditions

Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• SEVAL ULUBAY, phd

  IUC

  STUDY DIRECTOR

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: PhD

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: August 7, 2024
• Study Start: May 1, 2022
• Primary Completion: June 10, 2022
• Study Completion: May 31, 2023
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2022-2023
• Access Criteria: sevalulubay@gmail.com

Locations

TU (1)