Clinical trial NCT06862921: Effects of Dıfferent Tournıques and Posıtıons on Paın, Anxıety Levels and Applıcatıon Success in Perıpheral Intravenous Catheter Applıcatıon: a Randomızed Controlled Study
Official title: Effects of Dıfferent Tournıques and Posıtıons on Paın, Anxıety Levels and Applıcatıon Success in Perıpheral Intravenous Catheter Applıcatıon: a Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourniquets
INTRAVENOUS CATHETER APPLICATION
Keywords: Peripheral Catheterization; tourniquet; pain; anxiety
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

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  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:

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  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.

Primary outcomes:
measure: Visual Infusion Phlebitis Diagnostic Scale
timeFrame: 3 month
measure: Infiltration Scale (IS)
timeFrame: 3 month
measure: Visual Pain Scale (VAS):
timeFrame: 3 month
measure: Facial Anxiety Scale (FAS)
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital
state: İ̇stanbul
Study officials:
References:
citation: Tran QK, Flanagan K, Fairchild M, Yardi I, Pourmand A. Nurses and Efficacy of Ultrasound-Guided Versus Traditional Venous Access: A Systemic Review and Meta-Analysis. J Emerg Nurs. 2022 Mar;48(2):145-158.e1. doi: 10.1016/j.jen.2021.12.003. Epub 2022 Feb 4.
citation: Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.