Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847816
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-08
First Post:
2023-04-03
Brief Title:
The Effects of Three Different Techniques During PIVC
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
The Effects of Three Different Techniques During Peripheral Intravenous Cannulation PIVC Administered in Vein Visibility Pain and Comfort in Cancer Patients Receiving Palliative Care
Status:
NOT_YET_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:
Purpose This study will conducted to the effect of three different techniques used during peripheral intravenous cannulation PIVC application on vein visibility pain and comfort in cancer patients receiving palliative care
Design This is a prospective randomized controlled experimental study Methods The population of the research will be cancer patients who applied to Ege University Medical Faculty Hospital Oncology unit between April 2023 and November 2024 The number of applications due to palliative care and cancer treatment in the clinic in 2021 is 352 patients For this reason direct sample selection was not made in the study and the sample calculation was made according to the number of patients registered in the unit and the results of previous research Chiao et al 2013 Aulagnier et al 2014 Calculations were made using the GPower-317 program with 95 confidence an effect size of 04 and a statistical test power of at least 80 Accordingly it was aimed to reach 120 patients including at least 40 in each group In the study randomization will be made according to vein visibility
Design This is a prospective randomized controlled experimental study Methods The population of the research will be cancer patients who applied to Ege University Medical Faculty Hospital Oncology unit between April 2023 and November 2024 The number of applications due to palliative care and cancer treatment in the clinic in 2021 is 352 patients For this reason direct sample selection was not made in the study and the sample calculation was made according to the number of patients registered in the unit and the results of previous research Chiao et al 2013 Aulagnier et al 2014 Calculations were made using the GPower-317 program with 95 confidence an effect size of 04 and a statistical test power of at least 80 Accordingly it was aimed to reach 120 patients including at least 40 in each group In the study randomization will be made according to vein visibility
Detailed Description:
Purpose This study will conducted to the effect of three different techniques used during peripheral intravenous cannulation PIVC application on vein visibility pain and comfort in cancer patients receiving palliative care We will implement of the study during the insert on PIVC the vascular imaging device group isometric hand exercise group and control group
Design This is a prospective randomized controlled experimental study
Methods Implementation of the study in the control group The patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form Since it is stated in the literature that the placement of the PIVK in the arm that is not actively used is important in preventing complications PIVK will be placed in the arm that the patient does not actively use in groups Ingram and Lavery 2005 INS 2011 After the tourniquet is attached the stopwatch will be started and the catheter intervention process will be started when the vein visibility reaches the level where the nurse can insert the catheter The stopwatch will be terminated at the stage of advancing the branule into the vein and fixing it with a plaster If the catheterization application is successful or unsuccessful in the first attempt it will be recorded PIC success will be evaluated according to whether the branule is placed in the vein Successful catheter insertion will be considered as blood coming into the chamber of the catheter If the vein cannot be entered or blood is not coming to the catheter the catheterization will be considered unsuccessful Patients with two unsuccessful attempts per group will be excluded from the study as more than two unsuccessful attempts may result in infiltration INS 2011 Vein visibility after tourniquet application catheter number used in the procedure time to determine the appropriate vein successful catheter placement time number of attempts for successful catheter placement will be recorded in the intravenous chemotherapy application registration form The pain and arm comfort levels in the form will be evaluated on a scale ranging from 0 to 10 with 0 none 10 many before and after the application at the 5th 30th and 60th minutes
Implementation of the study in the vascular imaging device group The patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form After the tourniquet is attached the stopwatch will be started and the catheter intervention process will be started when the vein visibility reaches the level where the nurse can insert the catheter The stopwatch will be terminated at the stage of advancing the branule into the vein and fixing it with a plaster If the catheterization application is successful or unsuccessful in the first attempt it will be recorded PIC success will be evaluated according to whether the branule is placed in the vein Successful catheter insertion will be considered as blood coming into the chamber of the catheter Patients with two unsuccessful attempts per group will be excluded from the study as more than two unsuccessful attempts may result in infiltration INS 2011 Vein visibility after tourniquet application catheter number used in the procedure time to determine the appropriate vein successful catheter placement time number of attempts for successful catheter placement will be recorded in the intravenous chemotherapy application registration form The pain and arm comfort levels in the form will be evaluated on a scale ranging from 0 to 10 with 0 none 10 many before and after the application at the 5th 30th and 60th minutes
Isometric hand exercise The patients to be included in this group will have applied isometric hand squeeze exercise which lasted for twenty minutes a day five days a week before the PIVK procedure On the fifth day the patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form Patients will be told how to use the stress ball 5 minutes before and during the PIVK procedure before the procedure Patients will be taught to count from one to three and tighten and loosen the stress ball once and they will be told to continue squeezing and loosening the stress ball in this way until the procedure is over Focus their attention on the stress ball during the procedure
Design This is a prospective randomized controlled experimental study
Methods Implementation of the study in the control group The patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form Since it is stated in the literature that the placement of the PIVK in the arm that is not actively used is important in preventing complications PIVK will be placed in the arm that the patient does not actively use in groups Ingram and Lavery 2005 INS 2011 After the tourniquet is attached the stopwatch will be started and the catheter intervention process will be started when the vein visibility reaches the level where the nurse can insert the catheter The stopwatch will be terminated at the stage of advancing the branule into the vein and fixing it with a plaster If the catheterization application is successful or unsuccessful in the first attempt it will be recorded PIC success will be evaluated according to whether the branule is placed in the vein Successful catheter insertion will be considered as blood coming into the chamber of the catheter If the vein cannot be entered or blood is not coming to the catheter the catheterization will be considered unsuccessful Patients with two unsuccessful attempts per group will be excluded from the study as more than two unsuccessful attempts may result in infiltration INS 2011 Vein visibility after tourniquet application catheter number used in the procedure time to determine the appropriate vein successful catheter placement time number of attempts for successful catheter placement will be recorded in the intravenous chemotherapy application registration form The pain and arm comfort levels in the form will be evaluated on a scale ranging from 0 to 10 with 0 none 10 many before and after the application at the 5th 30th and 60th minutes
Implementation of the study in the vascular imaging device group The patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form After the tourniquet is attached the stopwatch will be started and the catheter intervention process will be started when the vein visibility reaches the level where the nurse can insert the catheter The stopwatch will be terminated at the stage of advancing the branule into the vein and fixing it with a plaster If the catheterization application is successful or unsuccessful in the first attempt it will be recorded PIC success will be evaluated according to whether the branule is placed in the vein Successful catheter insertion will be considered as blood coming into the chamber of the catheter Patients with two unsuccessful attempts per group will be excluded from the study as more than two unsuccessful attempts may result in infiltration INS 2011 Vein visibility after tourniquet application catheter number used in the procedure time to determine the appropriate vein successful catheter placement time number of attempts for successful catheter placement will be recorded in the intravenous chemotherapy application registration form The pain and arm comfort levels in the form will be evaluated on a scale ranging from 0 to 10 with 0 none 10 many before and after the application at the 5th 30th and 60th minutes
Isometric hand exercise The patients to be included in this group will have applied isometric hand squeeze exercise which lasted for twenty minutes a day five days a week before the PIVK procedure On the fifth day the patients vital signs skin color and skin turgor will be evaluated and recorded in the peripheral intravenous chemotherapy application registration form Patients will be told how to use the stress ball 5 minutes before and during the PIVK procedure before the procedure Patients will be taught to count from one to three and tighten and loosen the stress ball once and they will be told to continue squeezing and loosening the stress ball in this way until the procedure is over Focus their attention on the stress ball during the procedure
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