The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal

NCT05214703 | Completed

• 1 other identifier: YuksekIU-ABAHAR-002
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal.

Conditions

Pain; Anxiety

Keywords

Cancer; Venous Port Catheter; Cold Therapy; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Vertical Visual Analog Scale(VAS)

  Pain scores of the experimental and control groups were evaluated with VAS. The pain scores in both groups were shown to the patients by the researchers by showing the VAS, and they were asked to show at which point they experienced pain. The VAS scores of the patients in both groups were measured 10 minutes before the port catheter was removed (1st measurement), immediately after the catheter was removed (2nd measurement), and 10 minutes after the catheter was removed (3rd measurement). Pain intensity was measured by using a vertical visual analog scale(VAS) from "0 to 10", with high numbers meaning greater pain intensity. Iıt is indicated that compared with other tools, the vas is more sensitive and reliable in the measurement of pain intensity. Pain intensity can be categorized as mild (score, 1-3), moderate (score, 4-6), and severe (score, 7-10) according to the scale.

  20 minutes

Secondary Outcomes (1)

• The StateTrait Anxiety Inventory(STAI-I)

  20 minutes

Study Arms (2)

cold therapy

EXPERIMENTAL

Pain scores were measured with a visual analog scale (VAS) before the port catheter was removed from the patients in the experimental group. Before the port catheters were removed, cold application with an ice pack was applied to the patients whose first visual analog scale measurement was made by the researchers. The cold application was terminated an average of 15 minutes after the body temperature decreased by 1 °C.

Other: cold therapy application

no intervention

NO INTERVENTION

The patients in the control group did not receive any intervention before and after port catheter removal.

Interventions

cold therapy application OTHER

cold therapy

cold therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of cancer disease
• years and over
• no analgesic medication before three hours before the catheter removal procedure
• conscious and cooperative
• no communication problems
• no visual no vision problems
• with stable vital signs
• without a diagnosis of anxiety disorder
• volunteer participation

You may not qualify if:

• Body mass index less than 18.5
• receiving Oxaliplatin infusions before venous port catheter removal

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Arzu Bahar

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Bahar A, Aktas D, Sonmez M. Effects of Cold Therapy on Pain and Anxiety During Needle Removal From Implanted Ports. J Infus Nurs. 2023 Jan-Feb 01;46(1):36-42. doi: 10.1097/NAN.0000000000000495.

  PMID: 36571826 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Arzu bahar, PhD

  Yuksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Parallel Assignment a clinical trial with experimental and control groups with

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 31, 2022
• Study Start: February 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)