Hot and Cold Applications on PVC Insertion

NCT04177745 | Completed

• 1 other identifier: 444
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Venous Catheterization

Keywords

Peripheral venous catheter; hot application; cold application; pain; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Numeric Rating Scale for pain and anxiety

  During catheter insertion

• Vein Assessment Scale

  Immediately before insertion of the catheter

Study Arms (3)

Hot Application

EXPERIMENTAL

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

Cold Application

EXPERIMENTAL

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

Standard Practice

NO INTERVENTION

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.

Interventions

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.

Hot Application

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.

Cold Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sevda Korkut, Ph.D

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: November 20, 2018
• Primary Completion: November 20, 2018
• Study Completion: December 29, 2018
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

TU (1)