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Completed

NCT Number: NCT06862921

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

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.

Completed

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Key information

Conditions

Tourniquets Anxiety Disorders INTRAVENOUS CATHETER APPLICATION Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 week–64 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34704, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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:

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  • 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.

Treatment and study plan

Control

Other

fawler position using a standard tourniquet

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Acronym: CATHETER

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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