Clinical trial NCT05214703: The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal
Official title: The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Cancer
Venous Port Catheter
Cold Therapy
Pain
Anxiety
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment a clinical trial with experimental and control groups with
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vertical Visual Analog Scale(VAS)
timeFrame: 20 minutes
Secondary outcomes:
measure: The StateTrait Anxiety Inventory(STAI-I)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Arzu Bahar
Study officials:
affiliation: Yuksek Ihtisas University
name: Arzu bahar, PhD
role: PRINCIPAL_INVESTIGATOR
References: