Clinical trial

Investigation of the Effect of Jet Lidocaine and Ice Application on Reduction of Pain and Anxiety Related to Peripheral Venous Catheterisation in Adult Patients: A Randomised Controlled Trial

Name
ATATURKUNIVERSITYESRAAYDIN0029
Description
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.
Trial arms
Trial start
2022-02-15
Estimated PCD
2022-07-15
Trial end
2023-09-01
Status
Completed
Treatment
Jet lidocaine
Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later.
Arms:
Jet lidocaine group
Other names:
Intervention group-I
Ice
Ice will be applied for 1 minute before PVC, and then PVC will be performed.
Arms:
Ice group
Other names:
Intervention group-II
Standard PVC procedure
Standard PVC procedure will be applied
Arms:
Control group
Other names:
standard application group
Size
80
Primary endpoint
Visual Analogue Scale for Pain (VAS-P)
Within 1 minute after PVC application
Eligibility criteria
Inclusion Criteria: 1. Able to speak and understand Turkish, 2. Those between the ages of 18-50, 3. Demanding peripheral venous catheter insertion, 4. Having lidocaine request before PVC, 5. Having no problems with vision and hearing, 6. No history of secondary acute pain other than peripheral venous catheter, 7. Having no physical barrier to insertion of a catheter from the cephalic veins, 8. Not allergic to lidocaine and cold, 9. No signs of phlebitis, scar tissue, dermatitis, incision and infection in the area to be operated, 10. No history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain, 11. Individuals without coagulation disorder, liver failure, kidney and cardiovascular failure will be included in the study. Exclusion Criteria: 1. Cannot speak or understand Turkish, 2. Those who are outside the age range of 18-50, 3. No request for peripheral venous catheter insertion, 4. No lidocaine request before PVC, 5. Having any problems with vision and hearing, 6. Having a history of any secondary acute pain other than peripheral venous catheter, 7. Having a physical obstacle to insertion of a catheter from the cephalic veins, 8. Those who are allergic to lidocaine and cold, 9. With phlebitis, scar tissue, dermatitis, incision and infection findings in the area to be operated, 10. Having a history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain, 11. Patients with coagulation disorder, liver failure, kidney and cardiovascular failure
Protocol
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Updated at
2023-10-17

1 organization

2 products

1 indication

Organization
Ataturk University
Product
Ice