Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592807
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Perioperative Warm Socks on Maintaining Body Temperature in Patients Undergoing Spinal Surgery Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 36C 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 005 power080 d063 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 httpswwwrandomorginteger-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 hisher 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 hisher 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
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 005 power080 d063 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 httpswwwrandomorginteger-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 hisher 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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None