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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: cold therapy application

Detailed Description

Pain and anxiety experienced during diagnosis and treatment in cancer patients affect the physical, psychological, and interpersonal well-being of individuals and affect their lives in all aspects. Nurses play a very important role in pain control. Pain control is very important in terms of ensuring the comfort of patients and increasing their quality of life. In order to provide this control; nurses can use non-pharmacological treatment methods that they can apply independently in pain management. Patients experience procedural pain during insertion and removal of an implantable port catheter, which is one of the painful invasive procedures that are placed under the skin with a small incision, and insertion of a needle into the port catheter. When the literature is examined, it is seen that there are a limited number of studies in which non-pharmacological methods are used in the control of pain and anxiety related to the implantable venous port catheter procedure, and in these studies, distraction, music therapy, and inhaler aromatherapy. However, no study was found in which cold application was used to reduce the pain and anxiety caused by the removal of the port catheter in cancer patients. Therefore, the aim of the study is to evaluate the effectiveness of cold application on procedural pain and anxiety associated with port catheter removal, which is frequently used in the treatment of cancer patients. Cold therapy as an independent nursing intervention in reducing anxiety and pain management during port catheter removal in cancer/oncology patients; can be transferred to clinical practice by oncology nurses, improving the quality of nursing care, ensuring patient safety, and increasing patient satisfaction. In addition, the results of the research may contribute to the literature in terms of increasing evidence-based information on the use of the cold application in procedural pain and anxiety control in cancer patients.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Arzu Bahar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of cancer disease
• 18 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cold therapy; 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; cold therapy
No Intervention: no intervention; The patients in the control group did not receive any intervention before and after port catheter removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The StateTrait Anxiety Inventory(STAI-I)	The scores of the State-Trait Anxiety Inventory(STAI-I) Anxiety levels of the experimental and control groups were evaluated with STAI-I. The STAI-I scores of patients in both groups were measured 10 minutes before port catheter removal (1st measurement), and 10 minutes after catheter removal (2nd measurement). The patient's level of anxiety was evaluated by the State-Trait Anxiety Inventory(STAI-I.). While the first 20 items in the scale determine the state anxiety level, the second 20 items evaluate the trait anxiety level. The scores obtained from both scales theoretically vary between 20-80. In terms of anxiety levels in STAI-I, "0-19 points" from the scale, no anxiety, "20-39" points mild, "40-59" points moderate, "60-79" points severe, "80" score is evaluated as the level of panic and severe anxiety.	20 minutes

Collaborators and Investigators

• Sponsor: Yuksek Ihtisas University
• Investigators: Principal Investigator: Arzu bahar, PhD, Yuksek Ihtisas University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Pain; Anxiety; Venous Port Catheter; Cold Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: YuksekIU-ABAHAR-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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