The Effect of Sujok Therapy on Patient Comfort, Pain Intensity, and Anxiety Level in Cancer Patients With Port Catheter Placement

NCT06430177 | Completed

• 1 other identifier: 2024/07-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chemotherapy Effect

Keywords

Su Jok; Pain; Anxiety

Outcome Measures

Primary Outcomes (4)

• General Comfort Scale

  It is a four-point Likert type consisting of 48 items to measure the expected comfort result of the patient in order to test the taxonomic structure created after completing the conceptual studies of comfort. In this research, the scale adapted to Turkish by Kuğuoğlu and Karabacak was used. The scale is a four/six point Likert type and contains a total of 48 items. A four-point Likert type was preferred in the study due to its ease of use. Scale sub-dimensions; relief (16 items), relaxation (17 items) and overcoming problems (15 items). The response patterns of the scale, which consists of positive and negative items, are given in mixed order. Accordingly, in positive statements, a high score (4p) indicates high comfort, a low score (1p) indicates low comfort, in negative items, a low score (1p) indicates high comfort, and a high score (4p) indicates low comfort. In the evaluation of the scale; The negative scores obtained are reverse coded and added to the positive items.

  two hours later

• Visual Analog Scale - Anxiety

  The patients were asked to measure their anxiety level during rest or activity on a 10 cm long horizontal line. is requested to show. The value 0 is at the beginning of the line and 10 is at the end. 10 indicates extreme anxiety, 0 indicates not at all. It shows that there is no concern. VAS scale is used quite frequently during the evaluation of anxiety severity. is used

  two hours later

• Visual Analog Scale -Agrı

  It is used to convert some values that cannot be measured numerically into numerical values. Two extreme definitions of the parameter to be evaluated are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her situation is appropriate on this line by drawing a line, placing a dot, or pointing.

  two hours later

• State-Trait Anxiety Scale

  It is a scale developed to measure individuals' state and trait anxiety levels. It is a self-assessment scale whose Turkish validity and reliability studies have been conducted. In this study, the section of the scale measuring state anxiety was used to determine the state anxiety levels of the patients. State Anxiety Scale is a 4-point Likert type with 20 items and is scored according to the severity of the feelings, thoughts or behaviors expressed by the items as "not at all": 1, "somewhat": 2, "a lot": 3, "completely": 4. . The scale includes directly or reverse scored expressions.

  two hours later

Study Arms (2)

Experimental

EXPERIMENTAL

Su Jok will be done

Behavioral: Su Jok

Control

NO INTERVENTION

Interventions

Su Jok BEHAVIORAL

Su Jok will be done

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat university

Elâzığ, Center, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: November 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)