Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888818
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2023-05-03
Brief Title:
The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period
Sponsor:
Zonguldak Bulent Ecevit University
Organization:
Zonguldak Bulent Ecevit University
Study Overview
Official Title:
The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period - Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-05
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:
None
Brief Summary:
As a result of the literature review it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting and academic studies on this subject are needed
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period
The research hypotheses are as follows
H1Cold application method reduces nausea and vomiting in the early postoperative period
H1The cold application method reduces the need for antiemetic drugs in the early postoperative period
H1Cold application method in the early postoperative period increases patient satisfaction
Condition or disease
Postoperative nausea and vomitingPostoperative antiemetic use statusPatient satisfactionEffects of cold application method
Interventiontreatment
There is an intervention group in which the cold application method is applied
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period
The research hypotheses are as follows
H1Cold application method reduces nausea and vomiting in the early postoperative period
H1The cold application method reduces the need for antiemetic drugs in the early postoperative period
H1Cold application method in the early postoperative period increases patient satisfaction
Condition or disease
Postoperative nausea and vomitingPostoperative antiemetic use statusPatient satisfactionEffects of cold application method
Interventiontreatment
There is an intervention group in which the cold application method is applied
Detailed Description:
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period
The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024Çalışmanın örneklemini laparoskopik kolesistektomi planlanan dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır
As a result of the GPower power analysis it was calculated that at least 60 people at least 30 people for each group who met the inclusion criteria of the research should be taken in order to obtain 80 power at the 95 confidence interval for the d08 effect size
Data collecting
The collection of research data will be carried out in three stages
1 stagePatients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria and eligible patients will be invited to participate in the studyThe purpose of the research will be explained to the patients the informed consent form will be read written and verbal consent will be obtained and a copy of the form will be given to the patientsThen the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique and the answers given by the patients will be recorded
2 stage The surgery will be held in the recovery roomWhile the patients in the intervention group are in the recovery room after the surgery their routine applications will be made and the state of consciousness and alertness will be checkedAfter the application the presence of nausea severity vomiting status vital signs blood pressure pulse respiratory rate body temperature will be measuredThen a cold application with a cold gel pack will be applied to the nape area for 5 minutesPresence of nausea severity vomiting status vital signs will be re-measured immediately after the applicationAntiemetic drug use and opioid drug use will be questioned
3 stagePresence severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patientsAntiemetic drug use and opioid drug use will be questionedPatient satisfaction will be evaluated
The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024Çalışmanın örneklemini laparoskopik kolesistektomi planlanan dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır
As a result of the GPower power analysis it was calculated that at least 60 people at least 30 people for each group who met the inclusion criteria of the research should be taken in order to obtain 80 power at the 95 confidence interval for the d08 effect size
Data collecting
The collection of research data will be carried out in three stages
1 stagePatients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria and eligible patients will be invited to participate in the studyThe purpose of the research will be explained to the patients the informed consent form will be read written and verbal consent will be obtained and a copy of the form will be given to the patientsThen the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique and the answers given by the patients will be recorded
2 stage The surgery will be held in the recovery roomWhile the patients in the intervention group are in the recovery room after the surgery their routine applications will be made and the state of consciousness and alertness will be checkedAfter the application the presence of nausea severity vomiting status vital signs blood pressure pulse respiratory rate body temperature will be measuredThen a cold application with a cold gel pack will be applied to the nape area for 5 minutesPresence of nausea severity vomiting status vital signs will be re-measured immediately after the applicationAntiemetic drug use and opioid drug use will be questioned
3 stagePresence severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patientsAntiemetic drug use and opioid drug use will be questionedPatient satisfaction will be evaluated
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