Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05647889 |
| Other study ID # |
ATATURKUNIVERSITYESRAAYDIN0029 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigation of the Effect of Jet Lidocaine and Ice Application on Pain and Anxiety in
Peripheral Venous Catheterization (PVC). The research will be carried out experimentally with
a single group post-test method. The universe of the research; Between June-December 2022,
all patients who need peripheral venous catheterization (PVK) for the treatment plan will be
formed in the internal clinics of Gümüşhane State Hospital. The sample of the study will
consist of 80 patients from the defined population who meet the inclusion criteria. Power
analysis was used to determine the number of samples in the study. First of all, patients who
are hospitalized in the internal clinics of Gümüşhane State Hospital and who meet the
inclusion criteria will be determined. Written and verbal consent will be obtained for their
participation by giving information about the research. PVK application will be applied to
all patients by the same investigator. Each patient will create their own control group in
order to control individual differences in pain and anxiety. In the study consisting of two
intervention and a control group; The same patients will be included in the intervention
groups and the control group. Randomization will be done to determine the order of
intervention to be applied to the patients. The interventions for each patient will be
numbered by the researcher and the order of procedure will be determined by drawing lots.
After the cephalic vein for the first attempt is randomly determined, the other extremity
vein will be used while performing consecutive PVC applications. To control the research in
terms of bias; During the data collection phase, help will be taken from the clinical nurse
who takes care of the patient. The nurse, who does not know which intervention is applied,
will be asked to evaluate the patient's pain and anxiety. In this respect, the research will
be considered single-blind.
Description:
This study was planned as a randomized controlled, single-blind experiment. The research will
be carried out in the internal clinics of Gümüşhane State Hospital. Internal clinics were
preferred because patients hospitalized in surgical clinics experienced intense pain and
anxiety due to surgical operations. The universe of the research; All patients who are
hospitalized in the relevant clinics within the specified time period and who need to apply
PVC for the treatment plan will be formed.
The sample of the research; It will consist of 80 patients who are hospitalized in internal
clinics, who need PVC for diagnosis or treatment, and who meet the research criteria. Power
analysis was used to determine the number of samples in the study.The data of the research;
Patient Information Form will be collected using the Visual Analog Scale for Pain (VAS-P),
Visual Analog Scale for Anxiety (VAS-A), Wong-Baker Faces Pain Rating Scale. Nursing
Intervention: The research will be conducted experimentally with a single group post-test
method. First of all, patients who meet the criteria for inclusion in the study will be
determined, and written and verbal consent will be obtained for their participation by giving
information about the research. PVC application will be applied to all patients by the same
investigator. Each patient will create their own control group in order to control individual
differences in pain and anxiety. In the study consisting of two intervention and a control
group; The same patients will be included in the intervention groups and the control group.
Randomization will be done to determine the order of intervention to be applied to the
patients. Interventions will be numbered for each patient and the order of procedure will be
determined by drawing lots. After the cephalic vein for the first attempt is randomly
determined, the other extremity vein will be used while performing consecutive PVC
applications. To control the research in terms of bias; During the data collection phase,
help will be taken from the clinical nurse who takes care of the patient. The nurse, who does
not know which intervention is applied, will be asked to evaluate the patient's pain and
anxiety. In this respect, the research will be considered single-blind.
Intervention group-I (Jet lidocaine will be applied before PVC and PVC will be performed 3
minutes later) Intervention group-II (Ice application will be made for 1 minute before PVC
and then PVC will be performed) It will be named as the control group (Standard PVC procedure
will be applied)
Process steps
Control group PVC Application Steps
1. Hands will be washed.
2. The treatment tray will be prepared.
3. The correct patient will be determined, the procedure will be explained to the patient
and permission will be obtained.
4. A "Patient Identification Form" will be applied to the individual before PVC.
5. The individual will be given a fowler, semi fowler or supine position.
6. The area where PVC will be applied will be checked for phlebitis, thrombophlebitis,
ecchymosis, hematoma and signs of local infection.
7. The vein to be administered will be evaluated by observing and palpating in terms of
intervention.
8. By wearing gloves, the side grip sections of the peripheral venous catheter (22 G) will
be brought to the horizontal position.
9. A tourniquet will be attached 10-15 cm above the area where the catheter will be
entered.
10. The catheter will be held between the thumb and forefinger with the tapered side of the
needle facing up.
11. The individual will be asked to turn their head in the opposite direction to the side
where the peripheral venous catheter will be inserted.
12. Cleaning of the area will be done with a cotton pad with antiseptic in a single movement
in the direction of arterial blood circulation and it will be waited for about 5 seconds
for the area to dry.
13. The catheter will be held at an angle of 30-45° to the skin, approximately 1 cm below
the area where the vein is to be entered, and the vein will be accessed.
14. As soon as the needle enters the vein, it will be slowly advanced into the vein,
reducing the angle to approximately 15°.
15. It will be checked whether there is blood coming to the blood stopper valve and if there
is blood, the catheter will continue to be advanced in the vein.
16. At this stage, the needle of the catheter will be withdrawn with the passive hand, while
the plastic part will be advanced into the vein with the active hand simultaneously.
17. The level of pain related to the PVC application during the insertion of the catheter
will be evaluated by the clinical nurse with the Wong-Baker Faces Pain Rating Scale.
18. Without moving the catheter in the vein, the tourniquet will be loosened with the
inactive hand, fixed temporarily with a small patch, the needle of the catheter will be
removed and the cap of the catheter will be closed.
19. Permanent fixation of the catheter will be performed.
20. Contaminated materials will be removed from the environment.
21. Within 1 minute after catheter placement, patients' pain and anxiety levels related to
PVC application will be evaluated with VAS-A and VAS-P.
Intervention group-I PVC Application Steps
1. Implementation steps 1-7 of the Control Group will be done.
2. A tourniquet will be tied 10-15 cm above the area where the catheter will be inserted by
wearing gloves.
3. After the area to be intervened is determined, the tourniquet will be dissolved, the
area will be cleaned with a cotton pad with antiseptic from top to bottom in a single
movement, and the area will be waited for 5 seconds to dry.
4. The dermis layer on the vein determined for intervention will be pulled to the side with
the help of the passive hand (without any venous intervention), and the head of the
lidocaine-loaded jet device will be firmly placed on the cit at an angle of 90°.
5. Since 0.3 ml of lidocaine solution or 3 mg of total dose will not pose a problem in
terms of drug toxicity; 0.3 ml 1% lidocaine will be applied with a Jet device and waited
for 5 seconds.
6. After waiting for 5 seconds, the Jet device will be lifted and the skin will be
released.
7. Catheter intervention will be performed after 3 min to achieve optimal anesthetic
conditions.
8. The lateral grips of the peripheral venous catheter (22 G) will be placed in the
horizontal position.
9. The process will be completed by performing the steps between 9-11 and 13-21 of the
Control Group.
Initiative Group-II PVC Application Steps
1. Implementation steps of the Control Group 1-7 will be done.
2. In order to create an anesthetic effect; Ice will be applied for 1 minute to the
designated area to enter before PVC.
3. The process will be completed by performing the 8-21 application steps of the Control
Group.Variables of the Study Dependent variables were: Visual Analog Scale Score for
Anxiety (VAS-A), Visual Analog Scale Score for Pain (VAS-P), and Wong-Baker Faces Pain
Rating Scale Score.
Independent variables:
0.3 ml Jet lidocaine application before peripheral venous catheterization
1 minute ice application before peripheral venous catheterization
Control variables:
Peripheral venous catheterization site (Cephalic vein), Catheter diameter and length (22 G)
Evaluation of data: The data will be evaluated in the SPSS (Statistical Package for Social
Sciences for Windows, Version 22.0) package program. In the evaluation of the data, the
statistical significance value will be accepted as 0.05, the Type 1 error will be kept at 5%
and the evaluation will be made with a 95% confidence interval
