Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622850
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Effect of Acupressure on Pain Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Acupressure on Pain Anxiety and Hemodynamic Variables in Patients Undergoing Urodynamics a Randomized Controlled Study
Status:
NOT_YET_RECRUITING
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:
The study was planned as a randomized controlled experimental study to determine the effect of acupressure on pain anxiety and hemodynamic variables in patients undergoing urodynamics The study conducted by Azarkhavarani et al 2024 to determine the effect of acupressure on pain in elderly female patients undergoing extracorporeal shock wave lithotripsy was used as a reference in the calculation of sample size In the study the effect size of the difference between pain intensity after acupressure 633 054 in the experimental group and 736 054 in the control group was calculated as Cohen39s d 1907 In order to reach a higher sample size the minimum sample size was calculated as 34 in each group in the GPower 31 program with d08 1- α bidirectional 90 power taking the large effect size limit of 08 as a reference Descriptive Information Form Visual Analog Scale State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect the research data After the forms are applied to the patients and recorded it will be determined whether they will be in the study or control group according to the randomization schedule Acupressure will be applied to the patients in the study group by a certified researcher who has completed acupressure courses The control group will receive routine care After the acupressure application is completed urodynamics will be performed Pain anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure The data obtained in the study will be analyzed using SPSS Statistical Package for Social Sciences for Windows 250 program Descriptive statistical methods will be used to evaluate the data Parametric nonparametric tests will be used according to the suitability of the data used for normal distribution
Detailed Description:
The study was planned as a randomized controlled experimental study to determine the effect of acupressure on pain anxiety and hemodynamic variables in patients undergoing urodynamics The study conducted by Azarkhavarani et al 2024 to determine the effect of acupressure on pain in elderly female patients undergoing extracorporeal shock wave lithotripsy was used as a reference in the calculation of sample size In the study the effect size of the difference between pain intensity after acupressure 633 054 in the experimental group and 736 054 in the control group was calculated as Cohen39s d 1907 In order to reach a higher sample size the minimum sample size was calculated as 34 in each group in the GPower 31 program with d08 1- α bidirectional 90 power taking the large effect size limit of 08 as a reference Descriptive Information Form Visual Analog Scale State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect the research data After the forms are applied to the patients and recorded it will be determined whether they will be in the study or control group according to the randomization schedule Acupressure will be applied to the patients in the study group by a certified researcher who has completed acupressure coursesThe points to be used in acupressure will be Shen Men HT7 located in the transverse wrist bend in the small depression between the pisiform and ulna bones LI11 located at the end of the bend when the elbow is in the bent position and Hegu LI4 located in the space between the thumb and index finger will be marked by the certified researcher GB with an acetate pen in the patients in the study group And the application will be performed by the certified researcher GB Patients in the control group will not receive any application and will receive routine care After the acupressure application is completed urodynamics will be performed Pain anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure The data obtained in the study will be analyzed using SPSS Statistical Package for Social Sciences for Windows 250 program Descriptive statistical methods will be used to evaluate the data Parametric nonparametric tests will be used according to the suitability of the data used for normal distribution
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