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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214703
• Other study ID #: YuksekIU-ABAHAR-002
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: January 2022
• Source: Yuksek Ihtisas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Other:
• cold therapy application
cold therapy

Locations

Country	Name	City	State
Turkey	Arzu Bahar	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Iit 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	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