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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04177745
Other study ID # 444
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date December 29, 2018

Study information

Verified date August 2020
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 29, 2018
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Peripheral Venous Catheterization

Intervention

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.
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.

Locations

Country Name City State
Turkey Erciyes University Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
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