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

NCT06862921 | Completed

• 2 other identifiers: Uskudar UniversityClinical Research Ethics Commi
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourniquets; INTRAVENOUS CATHETER APPLICATION

Keywords

Peripheral Catheterization; tourniquet; pain; anxiety

Outcome Measures

Primary Outcomes (4)

• Visual Infusion Phlebitis Diagnostic Scale

  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)

  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):

  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)

  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

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

standard tourniquet in the supine position

Other: Control

Experimental Group 2

EXPERIMENTAL

sphygmomanometer at 60 mmHg pressure in the fawler position

Other: Control

Experimental Group 3

EXPERIMENTAL

sphygmomanometer at 60 mmHg pressure in the supine position

Other: Control

Interventions

Control OTHER

fawler position using a standard tourniquet

Experimental Group 1; Experimental Group 2; Experimental Group 3

Eligibility Criteria

• Age: 18 Weeks - 64 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient
• Volunteering to participate in the research
• Be between the ages of 18-64,
• The planned length of hospitalization is not less than 96 hours.

You may not qualify if:

• In the patient
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• Coagulation, hematologic and hydration problems
• 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,
• The presence of an obstacle (such as mastectomy) in the arm to be treated.
• Expulsion criteria from the study:
• <!-- -->
• Dislodgement of the peripheral intravenous catheter for any reason.
• Failure of peripheral intravenous catheter placement more than twice.
• Discharge of the patient from the hospital.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Istanbul, 34704, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35125291 BACKGROUND

• 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.

  PMID: 30948254 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

TU (1)