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

NCT ID: NCT06862921

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-01

Brief Summary

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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

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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.

Conditions

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Tourniquets INTRAVENOUS CATHETER APPLICATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Group 1

standard tourniquet in the supine position

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

fawler position using a standard tourniquet

Experimental Group 2

sphygmomanometer at 60 mmHg pressure in the fawler position

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

fawler position using a standard tourniquet

Experimental Group 3

sphygmomanometer at 60 mmHg pressure in the supine position

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

fawler position using a standard tourniquet

Interventions

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Control

fawler position using a standard tourniquet

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Weeks

Maximum Eligible Age

64 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Şerife Kelle Dikbaş

MSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35125291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30948254 (View on PubMed)

Other Identifiers

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Clinical Research Ethics Commi

Identifier Type: REGISTRY

Identifier Source: secondary_id

Uskudar University

Identifier Type: -

Identifier Source: org_study_id

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