Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06171347
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-27
Brief Title:
The Effect of Oral Cold Water Spray Application on Thirst Severity in Patients Undergoing Spinal Surgery
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
The Effect of Oral Cold Water Spray Application on Thirst Severity in Patients Undergoing Spinal Surgery A Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The aim of this study was to determine the effect of oral cold water spray application on thirst severity and patient satisfaction after spinal surgery
H1 Oral cold water spray application has an effect on thirst severity after spinal surgery
H2 Oral cold water spray application has an effect on salivary pH after spinal surgery
H3 Oral cold water spray application affects the satisfaction of patients after spinal surgery
H1 Oral cold water spray application has an effect on thirst severity after spinal surgery
H2 Oral cold water spray application has an effect on salivary pH after spinal surgery
H3 Oral cold water spray application affects the satisfaction of patients after spinal surgery
Detailed Description:
The randomized controlled trial will be conducted in the brain and neurosurgery service of Trakya University Health Research and Application Centre Date of research will be conducted between December 2023 and March 2024 The research sample will consist of 62 volunteer patients The sample was determined using power analysis at the research planning stage The minimum number of people to be included in the sample was calculated as 62 each group consisting of 31 11 patients with an effect size of 075 95 confidence level 5 tolerance and 80 power ratio using the GPower 3194 program Data Collection Forms Patient information form The form was developed by the researchers in line with the literature and consisted of 9 questions inquiring information about age gender educational status height body weight marital status habits physician diagnosis presence of chronic diseases etc
ostoperative patient follow-up form There are 11 questions in the form The answers to the first 9 questions will be obtained by interviewing the patient face to face The eleventh question type of fluid taken during surgery and the answer to the twelfth question amount of bleeding during surgery will be obtained from the anaesthesia transfer form
The severity of thirst and discomfort levels of the patients will be evaluated numerically four times and saliva pH levels will be evaluated twice before the first application and 1 hour after the end of the whole application with the chart at the end of the form Visual Analogue Scale values The Visual Analogue Scale which is used to convert data that cannot be evaluated numerically into numerical form is 10 cm long and is graded on a horizontal or vertical line Since thirst is a state of discomfort consisting of subjective experiences expressed by the person it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies The scale includes 2 questions evaluating the severity of thirst and the severity of discomfort from thirst numerically between 0-10 Patient satisfaction form The satisfaction of the patients in the experimental group with the oral cold water spray application will be evaluated with a numerical rating scale ranging from 0 to 10 points 0 I am not satisfied at all 10 I am very satisfied
Data collection process Patients who meet the inclusion criteria will be informed verbally and in writing about the study scales etc in the preoperative period and the informed consent form will be signed Patient Information Form will be applied in the preoperative period The data of the study will be collected by the researcher in the patient room by face-to-face interview method
On postoperative day 0 all patients will be verbally informed by the ward nurses about the standard guidelines and care to be followed after spinal surgery after admission to the ward
Patients in the control group will not receive any intervention to quench thirst The questions in the postoperative patient follow-up form will be asked by the researcher and the postoperative patient follow-up form will be filled out
After the standard care of the service is applied to the patients in the experimental group the patients will be evaluated by the researcher nurse with the Safe Protocol in the Management of Thirst in the Early Postoperative Period in the 2nd postoperative hour after admission to the service The postoperative patient follow-up form will be applied to patients with appropriate criteria Saliva pH will be evaluated before the first set Afterwards 05 ml of oral cold water spray kept in the 40C service refrigerator will be applied Thirty minutes later 05 ml of oral cold water spray which has been kept in the 40C service refrigerator will be applied for the second time The first set will be completed In the third hour the severity of thirst and discomfort due to thirst will be evaluated with the chart in the postoperative patient follow-up form In the fourth hour 05 ml oral cold water spray kept in the 40C service refrigerator will be applied Thirty minutes later 05 ml of oral cold water spray kept in the 40C service refrigerator will be applied again The second set will be completed In the fifth hour the severity of thirst and discomfort due to thirst and saliva Ph will be evaluated with the chart in the postoperative patient follow-up form In addition patients satisfaction with oral cold water spray application will be evaluated Data collection will end after the completion of the questionnaire applications
ostoperative patient follow-up form There are 11 questions in the form The answers to the first 9 questions will be obtained by interviewing the patient face to face The eleventh question type of fluid taken during surgery and the answer to the twelfth question amount of bleeding during surgery will be obtained from the anaesthesia transfer form
The severity of thirst and discomfort levels of the patients will be evaluated numerically four times and saliva pH levels will be evaluated twice before the first application and 1 hour after the end of the whole application with the chart at the end of the form Visual Analogue Scale values The Visual Analogue Scale which is used to convert data that cannot be evaluated numerically into numerical form is 10 cm long and is graded on a horizontal or vertical line Since thirst is a state of discomfort consisting of subjective experiences expressed by the person it is stated in the literature that the use of the Visual Analogue Scale in the evaluation of thirst is appropriate and can be used safely in studies The scale includes 2 questions evaluating the severity of thirst and the severity of discomfort from thirst numerically between 0-10 Patient satisfaction form The satisfaction of the patients in the experimental group with the oral cold water spray application will be evaluated with a numerical rating scale ranging from 0 to 10 points 0 I am not satisfied at all 10 I am very satisfied
Data collection process Patients who meet the inclusion criteria will be informed verbally and in writing about the study scales etc in the preoperative period and the informed consent form will be signed Patient Information Form will be applied in the preoperative period The data of the study will be collected by the researcher in the patient room by face-to-face interview method
On postoperative day 0 all patients will be verbally informed by the ward nurses about the standard guidelines and care to be followed after spinal surgery after admission to the ward
Patients in the control group will not receive any intervention to quench thirst The questions in the postoperative patient follow-up form will be asked by the researcher and the postoperative patient follow-up form will be filled out
After the standard care of the service is applied to the patients in the experimental group the patients will be evaluated by the researcher nurse with the Safe Protocol in the Management of Thirst in the Early Postoperative Period in the 2nd postoperative hour after admission to the service The postoperative patient follow-up form will be applied to patients with appropriate criteria Saliva pH will be evaluated before the first set Afterwards 05 ml of oral cold water spray kept in the 40C service refrigerator will be applied Thirty minutes later 05 ml of oral cold water spray which has been kept in the 40C service refrigerator will be applied for the second time The first set will be completed In the third hour the severity of thirst and discomfort due to thirst will be evaluated with the chart in the postoperative patient follow-up form In the fourth hour 05 ml oral cold water spray kept in the 40C service refrigerator will be applied Thirty minutes later 05 ml of oral cold water spray kept in the 40C service refrigerator will be applied again The second set will be completed In the fifth hour the severity of thirst and discomfort due to thirst and saliva Ph will be evaluated with the chart in the postoperative patient follow-up form In addition patients satisfaction with oral cold water spray application will be evaluated Data collection will end after the completion of the questionnaire applications
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