Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357429
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2024-03-30
Brief Title:
Evaluation of the Effect of the LI4 Cold Application
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
Evaluation of the Effect of Cold Application on the LI4 Point After Surgery on Acute Pain Nausea and Anxiety Level
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LI4
Brief Summary:
It is an experimental study conducted to evaluate the effectiveness of cold application to the LI4 point of the hand to reduceeliminate pain nausea and anxiety in postoperative patients The population of the study consisted of 116 individuals who underwent abdominal surgery with the open surgery method in a state hospital between February 2022 and November 2022 and were followed up in the inpatient ward The study was completed with 80 individuals constituting the experimental group n40 and the control group n40 Patient information form Mcgill Melzack short pain form Visual Analog Scale STAI - TX and Cold Application Evaluation Form were used to collect data Patients in the experimental group underwent cold application with ice cubes for a total of 20 minutes as 2 minutes of cold application and 15 seconds of waiting 4-6 hours after the patient was admitted to the clinic after surgical intervention Follow-up was performed before cold application immediately after cold application 30 minutes after the end of cold application 1 hour and 2 hours after the end of cold application
Detailed Description:
It is a prospective study in which cold application is planned to reduceeliminate the pain nausea and anxiety experienced by patients after surgery There are 2 different sample groups in the study The first group consists of the experimental group in which cold application is planned to be applied to the hand LI4 point after surgical intervention and the control group in which routine interventions in the clinic are applied
Hypotheses H1 The pain levels of individuals who received cold application to the LI4 point after surgery are lower than those who received routine care
H2 Anxiety levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care
H3 The nausea levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care
Variables of the Study Independent Variables Cold Application Dependent Variables Socio-demographic characteristics pain level anxiety level vital signs body temperature blood pressure pulse respiration analgesic drug use nausea level The study was conducted in the inpatient wards of a state hospital
Research data were collected every weekday between February 28 2022 and November 18 2022 on Monday-Tuesday-Wednesday-Thursday-Thursday-Friday
The study population consisted of 116 individuals who underwent abdominal surgery and were followed up in the inpatient ward Inclusion Criteria
Over 18 years of age
Can speak and understand Turkish
Does not have any cognitive affective and verbal problems that prevent them from communicating
No postoperative complications developed
Underwent surgery with general anesthesia
No cold allergies
Standardized analgesia protocol implemented
Intensive care follow-up continues as of the fourth hour of the postoperative period
Women without a physical hand or arm disability will be included Patient information form Mcgill Melzack short pain form Visual Analog Scale STAI - TX and Cold Application Evaluation Form were used to collect data In order to evaluate the comprehensibility of the forms created for data collection and the designed cold application process a pre-application was performed with the participation of 10 patients who underwent open surgical intervention in the abdominal region in the inpatient ward of the hospital
The data of the patients within the scope of the preliminary application were not included in the sample
After the patient was taken to the individual room hisher clinical status was evaluated The purpose of the study LI4 cold application method and its effect on pain were explained Life findings were measured Then pain assessment was performed using the SCS and Mcgill Pain Scale Short Form State Anxiety Scale and Trait Anxiety Scale were completed by the researcher using face-to-face interview method After the end of the application the patients vital signs were evaluated The efficacy of cold application was evaluated with SCS Mcgill Pain Scale Short Form State Anxiety Scale At 30 60 and 120 minutes after cold application the same evaluations made after the application were repeated and recorded After the 120th minute evaluation the Cold Application Evaluation Form was completed
Hypotheses H1 The pain levels of individuals who received cold application to the LI4 point after surgery are lower than those who received routine care
H2 Anxiety levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care
H3 The nausea levels of individuals who underwent cold application to the LI4 point after surgery are lower than those who received routine care
Variables of the Study Independent Variables Cold Application Dependent Variables Socio-demographic characteristics pain level anxiety level vital signs body temperature blood pressure pulse respiration analgesic drug use nausea level The study was conducted in the inpatient wards of a state hospital
Research data were collected every weekday between February 28 2022 and November 18 2022 on Monday-Tuesday-Wednesday-Thursday-Thursday-Friday
The study population consisted of 116 individuals who underwent abdominal surgery and were followed up in the inpatient ward Inclusion Criteria
Over 18 years of age
Can speak and understand Turkish
Does not have any cognitive affective and verbal problems that prevent them from communicating
No postoperative complications developed
Underwent surgery with general anesthesia
No cold allergies
Standardized analgesia protocol implemented
Intensive care follow-up continues as of the fourth hour of the postoperative period
Women without a physical hand or arm disability will be included Patient information form Mcgill Melzack short pain form Visual Analog Scale STAI - TX and Cold Application Evaluation Form were used to collect data In order to evaluate the comprehensibility of the forms created for data collection and the designed cold application process a pre-application was performed with the participation of 10 patients who underwent open surgical intervention in the abdominal region in the inpatient ward of the hospital
The data of the patients within the scope of the preliminary application were not included in the sample
After the patient was taken to the individual room hisher clinical status was evaluated The purpose of the study LI4 cold application method and its effect on pain were explained Life findings were measured Then pain assessment was performed using the SCS and Mcgill Pain Scale Short Form State Anxiety Scale and Trait Anxiety Scale were completed by the researcher using face-to-face interview method After the end of the application the patients vital signs were evaluated The efficacy of cold application was evaluated with SCS Mcgill Pain Scale Short Form State Anxiety Scale At 30 60 and 120 minutes after cold application the same evaluations made after the application were repeated and recorded After the 120th minute evaluation the Cold Application Evaluation Form was completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None