Pain and Anxiety in Peripheral Venous Catheterization, Jet Lidocaine, Ice Application

NCT05647889 | Completed

• 1 other identifier: ATATURKUNIVERSITYESRAAYDIN0029
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Venous Catheterization

Keywords

Pain; Anxiety; Ice application; Jet Lidocaine; Nursing; Peripheral venous catheterization

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for Pain (VAS-P)

  It is a scale used to evaluate the severity of pain. It is a 100 mm ruler with painlessness at one end and the most severe pain at the other. "0" denotes painlessness, and "100" denotes the most severe pain.A low score from the scale indicates that the application is beneficial.

  Within 1 minute after PVC application

Secondary Outcomes (1)

• Visual Analogue Scale for Anxiety (VAS-A)

  Within 1 minute after PVC application

Other Outcomes (1)

• Wong-Baker Faces Pain Rating Scale

  While performing the PVC application

Study Arms (3)

Jet lidocaine group

EXPERIMENTAL

Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later.

Drug: Jet lidocaine

Ice group

EXPERIMENTAL

Ice will be applied for 1 minute before PVC, and then PVC will be performed.

Combination Product: Ice

Control group

ACTIVE COMPARATOR

Standard PVC procedure will be applied

Other: Standard PVC procedure

Interventions

Jet lidocaine DRUG

Jet lidocaine will be applied before PVC and PVC will be performed 3 minutes later.

Also known as: Intervention group-I

Jet lidocaine group

Ice COMBINATION_PRODUCT

Ice will be applied for 1 minute before PVC, and then PVC will be performed.

Also known as: Intervention group-II

Ice group

Standard PVC procedure OTHER

Standard PVC procedure will be applied

Also known as: standard application group

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to speak and understand Turkish,
• Those between the ages of 18-50,
• Demanding peripheral venous catheter insertion,
• Having lidocaine request before PVC,
• Having no problems with vision and hearing,
• No history of secondary acute pain other than peripheral venous catheter,
• Having no physical barrier to insertion of a catheter from the cephalic veins,
• Not allergic to lidocaine and cold,
• No signs of phlebitis, scar tissue, dermatitis, incision and infection in the area to be operated,
• No history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain,
• Individuals without coagulation disorder, liver failure, kidney and cardiovascular failure will be included in the study.

You may not qualify if:

• Cannot speak or understand Turkish,
• Those who are outside the age range of 18-50,
• No request for peripheral venous catheter insertion,
• No lidocaine request before PVC,
• Having any problems with vision and hearing,
• Having a history of any secondary acute pain other than peripheral venous catheter,
• Having a physical obstacle to insertion of a catheter from the cephalic veins,
• Those who are allergic to lidocaine and cold,
• With phlebitis, scar tissue, dermatitis, incision and infection findings in the area to be operated,
• Having a history of peripheral nerve disease, peripheral neuropathy, paresis, plegia or hemiplegia that may affect the sensation of pain,
• Patients with coagulation disorder, liver failure, kidney and cardiovascular failure

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Ataturk University Faculty of Nursing

Erzurum, Centre, 25100, Turkey (Türkiye)

Location

Gumushane Health Services Vocational School

Gümüşhane, Centre, 29100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Ice

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Esra Aydın

  esraaydin@gumushane.edu.tr-0456 2331149

  PRINCIPAL INVESTIGATOR

• Gülçin Avşar

  gulcin.avsar@atauni.edu.tr-0 442 2311584

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: In the study, 80 individuals, including 2 experimental and 1 control group, were included in the study.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 13, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: September 1, 2023
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)