Effects of Dıfferent Tournıques and Posıtıons on Paın, Anxıety Levels and Applıcatıon Success in Perıpheral Intravenous Catheter Applıcatıon: a Randomızed Controlled Study (CATHETER)

March 3, 2025 updated by: Şerife Kelle Dikbaş, Istanbul University - Cerrahpasa

Aim:

The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.

Design:

Randomized controlled experimental design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim:

The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.

Primary purpose:investigate the effect of different tourniquet and position on pain, Secondary purpose:investigate the effect of different tourniquet and position on anxiety level and success of peripheral intravenous catheter (PIC) application.

Design:

Randomized controlled experimental design.

Methods:

The randomized controlled experimental design study was conducted with 110 adult patients in the orthopedic department of a Training and Research Hospital between May 2024 and July 2024. Data were collected using the Patient Information Form, Visual Infusion Phlebitis Diagnostic Scale, Infiltration Scale, Visual Pain Scale, and Facial Anxiety Scale. PIC was applied to patients in the "Experimental Group 1" using a standard tourniquet in the supine position, to patients in the "Experimental Group 2" using a sphygmomanometer at 60 mmHg pressure in the fawler position, and to patients in the "Experimental Group 3" using a sphygmomanometer at 60 mmHg pressure in the supine position. In the control group, a peripheral intravenous catheter was applied in the fawler position using a standard tourniquet. Patients were asked to evaluate the level of pain and anxiety before and after the application. The patients were followed up for phlebitis and extravasation findings at eight-hour intervals after the application. Except for complications requiring removal of the peripheral intravenous catheter during follow-up, the PIC was removed 96 hours after application. The results were evaluated at 95% confidence intervals with a significance level of p ≤ 0.05.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇stanbul
      • İstanbul, İ̇stanbul, Turkey, 34704
        • Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient

    1. Volunteering to participate in the research
    2. Be between the ages of 18-64,

    3. The planned length of hospitalization is not less than 96 hours.

      Exclusion Criteria:

      In the patient

    1. Coagulation, hematologic and hydration problems
    2. Oncological, allergic diseases, any incision or scar tissue in the antecubital area, presence of complications due to a previously opened catheter, presence of pain, hematoma, ecchymosis in the application area, or presence of any other injection in the antecubital area on treatment days,

    3. The presence of an obstacle (such as mastectomy) in the arm to be treated.

      Expulsion criteria from the study:

    1. Dislodgement of the peripheral intravenous catheter for any reason.
    2. Failure of peripheral intravenous catheter placement more than twice.
    3. Discharge of the patient from the hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1
standard tourniquet in the supine position
Other: Control
fawler position using a standard tourniquet
Experimental: Experimental Group 2
sphygmomanometer at 60 mmHg pressure in the fawler position
Other: Control
fawler position using a standard tourniquet
Experimental: Experimental Group 3
sphygmomanometer at 60 mmHg pressure in the supine position
Other: Control
fawler position using a standard tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Infusion Phlebitis Diagnostic Scale
Time Frame: 3 month
This scale developed by Schultze and Gallant (2006) was published by the Infusion Nurses Society (2006) and is a widely used scale in the clinical evaluation of infusion phlebitis. Phlebitis assessment was evaluated by the investigator using the VIFFS once every eight hours until the PIC was removed and recorded on the patient follow-up form.
3 month
Infiltration Scale (IS)
Time Frame: 3 month
Infiltration Scale (IS): This scale was published by the Intravenous Nurses Association (2006) and its psychometric properties were evaluated by Groll et al. Infiltration assessment was evaluated by the investigator using the IS once every eight hours until the PIC was removed and recorded on the patient follow-up form
3 month
Visual Pain Scale (VAS):
Time Frame: 3 month
Visual Pain Scale (VAS): This scale was developed by Hayes and Patterson in 1921 and is used to assess pain intensity. Pain intensity is measured using a 10 cm visual scale; mean pain scores ranging from 0 to 10 are given. zero indicates the absence of pain, ten indicates the presence of severe pain. A VAS value of one to four indicates mild pain, five to six indicates moderate pain, and seven to ten indicates severe pain. The researcher asked the patient to indicate the severity of pain according to VAS before and after PIC placement and recorded the value on the patient follow-up form.
3 month
Facial Anxiety Scale (FAS)
Time Frame: 3 month
Facial Anxiety Scale (FAS): The Turkish validity and reliability of the scale developed by McKinley, Coote, and Stein-Parbury (2003) was performed by İyigün, Pazar, and Taştan (2016). The Face Anxiety Scale is 11 × 42 cm in size. It consists of five different facial expressions, the leftmost facial expression indicates the absence of anxiety, while the level of anxiety increases from left to right. The FAS is scored from zero to five from left to right, respectively. A score of three on this scale indicates moderate anxiety, while a score of four and above indicates high anxiety. In this scale, the patient evaluates his/her own anxiety (McKinley 2004). The researcher showed the scale to the patient before and after PIC placement and asked the patient to evaluate which facial expression corresponded to his/her anxiety level and recorded the result on the patient follow-up form.Application of research
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uskudar University
  • Clinical Research Ethics Commi (Registry Identifier: 2024/74)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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