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Completed

NCT Number: NCT04177745

Hot and Cold Applications on PVC Insertion

Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. PVC was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.

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Key information

Conditions

Peripheral Venous Catheterization Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

About this study

Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.

Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. The sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the Cardiology Clinic between November and December 2018.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • being able to speak and understand Turkish,
  • being over 18 years of age,
  • having unimpaired sense of time or place orientation,
  • having no psychiatric disorders,
  • having no visual or hearing problem,
  • having indication of IV catheter application,
  • having no administration of analgesic or anaesthetic agents prior to IV catheter insertion,
  • having catheter inserted in one attempt,
  • having no allergy to hot and cold applications,
  • being voluntary to participate in the study.

Exclusion criteria

  • infection
  • previous history of surgery,
  • scarring in the catheter insertion site,
  • psoriasis in the catheter insertion site,
  • active dermatitis in the catheter insertion site,
  • peripheral nerve disease,
  • diabetes,
  • peripheral neuropathy in the catheter insertion site

Treatment and study plan

Hot application

Other

Before PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute.

Cold Application

Other

Before PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute.

Primary outcomes

  1. Numeric Rating Scale for pain and anxiety

    Time frame: Before catheter insertion

    The number "0" on the scale means that they do not feel any pain / anxiety and the number "10" refers to the worst pain and the highest level of anxiety.

  2. Vein Assessment Scale

    Time frame: Before hot/cold application

    There are 5 assessment steps: (1) veins are neither visible nor palpable, (2) veins are visible but not palpable, (3) veins are barely visible and palpable, (4) veins are visible and palpable, and (5) veins are clearly visible and easily palpable

Secondary outcomes

  1. Numeric Rating Scale for pain and anxiety

    Time frame: During catheter insertion

    The number "0" on the scale means that they do not feel any pain / anxiety and the number "10" refers to the worst pain and the highest level of anxiety.

  2. Vein Assessment Scale

    Time frame: Immediately before insertion of the catheter

    There are 5 assessment steps: (1) veins are neither visible nor palpable, (2) veins are visible but not palpable, (3) veins are barely visible and palpable, (4) veins are visible and palpable, and (5) veins are clearly visible and easily palpable

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effectiveness of Local Hot and Cold Applications on Peripheral Intravenous Catheters: A Randomised Control Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2019
Registry last updated
Aug 31, 2020

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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