Port Catheter Needle Change: Pain, Anxiety and Patient Satisfaction

NCT07679295 | Enrolling By Invitation

• 1 other identifier: Port
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Port catheters play a significant role in the management of cancer patients and eliminate the need for serial peripheral access by reducing patient anxiety associated with repeated venous punctures. In particular, inserting the needle into a subcutaneous port can be painful, frightening, and uncomfortable, even when the skin is numbed with a local anesthetic. Therefore, this study aims to investigate the effects of stress ball use on pain, anxiety, and patient satisfaction during port catheter needle changes in oncology patients.

Conditions

Vascular Access

Keywords

Vascular Access Devices; pain; anxiety; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient-reported information and state anxiety level before port catheter needle replacement

  The State Anxiety Scale is a 20-item, 4-point Likert-type scale designed to determine how an individual feels at a given moment and under specific conditions. In the State Anxiety Inventory, the individual is asked to rate how they feel "right now" and choose one of the following options based on the intensity of the emotion or behavior expressed in the items: (1) "none", (2) "a little", (3) "a lot", and (4) "completely". The highest score of 4 is given for choosing "completely", and the lowest score of 1 is given for choosing "none". The lowest possible total score on the State Anxiety Scale is 20, and the highest is 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.

  On the day of port catheter needle replacement, prior to the procedure

Secondary Outcomes (3)

• Pain intensity after port catheter needle replacement

  Data will be collected within 15 minutes after completion of port catheter needle replacement.

• Patient satisfaction after port catheter needle replacement

  Data will be collected within 15 minutes after completion of port catheter needle replacement

• State anxiety level after port catheter needle replacement

  Data will be collected within 15 minutes after completion of port catheter needle replacement.

Study Arms (2)

Control Group

NO INTERVENTION

This is control group

Stress ball

EXPERIMENTAL

experimenal group

Behavioral: Stress ball

Interventions

Stress ball BEHAVIORAL

After randomization, patients assigned to the intervention group will be informed about the study beforehand and their informed consent will be obtained. Subsequently, each patient will be given both theoretical and practical instructions on how to use the stress ball, and will be asked to practice. Patients will be given individual stress balls approximately 6 cm in diameter, of medium firmness, and made of medical-grade silicone. Patients who successfully use the stress ball will be instructed to take deep breaths, squeeze the stress ball in their hands, and exhale to release it for approximately 5-10 minutes during the port catheter change procedure. The practice will be observed by the researcher to ensure standardization. Throughout the study, all port catheter changes will be performed by the same nurse in the clinic, who is not involved in the study.

Stress ball

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age,
• Receiving treatment and care in the oncology ward,
• Having the hand function to physically use a stress ball,
• Patients who volunteer to participate in the study will be included.

You may not qualify if:

• Patients who cannot be communicated with,
• Those with peripheral neuropathic complaints,
• Those with psychiatric diagnoses,
• Patients who refuse to participate in the study will not be included.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Şanlıurfa Mehmet Akif İnan Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 1, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): September 29, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

TU (1)