Hot and Cold Applications on PVC Insertion

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Venous Catheterization
• Intervention / Treatment: Other: Hot application; Other: Cold application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hot Application; 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. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm.	Other: Hot application; 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.
Experimental: Cold Application; 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. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm.	Other: Cold application; 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.
No Intervention: Standard Practice; The standard practice of the clinic was made. Accordingly, the researcher performed the vein assessment after the participants filled out the questionnaire, and then inserted the 20-G catheter into the inner surface of their forearm without any application. Afterwards, she assessed the pain and anxiety levels of the patients twice before and after the catheter insertion procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale for pain and anxiety	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.	Before catheter insertion
Vein Assessment Scale	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	Before hot/cold application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale for pain and anxiety	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.	During catheter insertion
Vein Assessment Scale	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	Immediately before insertion of the catheter

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: Sevda Korkut, Ph.D, TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): December 29, 2018

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pain; anxiety; Peripheral venous catheter; cold application; hot application
• Other Study ID Numbers: 444

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No