Clinical trial NCT06430177: The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement
Official title: The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement: A Randomized, Placebo and Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Chemotherapy Effect
Keywords: Su Jok
Pain
Anxiety
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer is a fatal disease characterized by uncontrolled growth and proliferation of tissues and organs in the human body. Among cancer treatments, chemotherapy is the most commonly used treatment method. The drugs used in chemotherapy cause vascular toxic effects during administration, frequent blood samples taken from the patient, antibiotic treatments applied, parenteral nutrition treatments. Subcutaneous venous port catheter (SCVPK), which is a permanent and long-term vascular access route that can be used for medical purposes and in emergency situations, is a frequently preferred and safe intravenous access route because it is not visible outside the body, is well tolerated by the patient, and has a low risk of infection. However, invasive procedures such as port needle insertion and replacement can also cause pain, anxiety and changes in vital signs in patients. Nowadays, the use of non-pharmacological approaches as well as pharmacological methods is increasing in the management of symptoms such as anxiety before the invasive procedure and pain during application in patients receiving chemotherapy treatment. These approaches improve the quality of life of patients and have a positive physiological effect. One of these approaches is sujok therapy. In Su Jok application; The reflection points of the organs are on the hands and feet. These points reflect to the body organ in that area and healing occurs. By finding the right point, energy flow is provided by massaging with appropriate applicators. This research will be conducted to examine the effect of Sujok therapy on pain intensity and anxiety level in cancer patients who have undergone port catheter placement.

The research will be conducted as a randomized experimental and placebo study with a pretest-posttest control group in the oncology service of Fethi Sekin City Hospital. 90 (30 experimental, 30 control, 30 placebo) cancer patients who accept the research and meet the sample criteria of the study will be subjected to port catheter application. Application areas for pain, anxiety and stress before the port catheter to the patients in the experimental group will be determined with the help of a probe (diagnostic stick), and seeds will be added to these points approximately 45 minutes before the application and fixed with a patch. For cancer patients in the placebo group, the same procedure will be performed with seeds that have a neutral effect on the body. No procedure will be applied to the patients in the control group. Patient Information Form, General Comfort Scale (GAS), Visual Analog Scale -Pain (VAS-P), Visual Analog Scale -Anxiety (VAS-A) and State-Trait Anxiety Scale were used as data collection tools. (DSKÖ) scale will be used. SPPS 21.0 (Statistical Programme for Social Sciences) package program will be used to evaluate the data obtained from the research. It is thought that if the objectives of the study are achieved, it will help reduce the level of pain and anxiety that may occur during and after port catheter application. In addition, it will contribute to the professional advancement of the project manager, which is a career development project. The positive results in this study will guide other interventions to increase the comfort level of cancer patients who will undergo port catheterization and reduce the level of pain and anxiety.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Ability to communicate adequately
* Being diagnosed with cancer
* Will receive chemotherapy treatment
* Port catheter placement will be performed
* Suitable for Implantable Port Catheter Placement

Exclusion Criteria:

* Loss of sensation in the hands, amputation, injury, etc. that would prevent practice. to be
* Patients with chronic pain or anxiety disorders, using any analgesics or anxiolytics

Primary outcomes:
measure: General Comfort Scale
timeFrame: two hours later
measure: Visual Analog Scale - Anxiety
timeFrame: two hours later
measure: Visual Analog Scale -Agrı
timeFrame: two hours later
measure: State-Trait Anxiety Scale
timeFrame: two hours later
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat university
state: Center
Study officials:
References: