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Enrolling by invitation NCT07679295

Port Catheter Needle Change: Pain, Anxiety and Patient Satisfaction

No phase Interventional Vascular Access

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stress ball.
Who it may be relevant to
Registry conditions: Vascular Access. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Stress Ball Application During Port Catheter Needle Change on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Study

Overview

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.

Interventions

  • Behavioral Stress ball
    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

Primary outcome measures

  • Patient-reported information and state anxiety level before port catheter needle replacement [Time frame: On the day of port catheter needle replacement, prior to the procedure]
Secondary outcome measures (3)
  • Pain intensity after port catheter needle replacement [Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement.]
  • Patient satisfaction after port catheter needle replacement [Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement]
  • State anxiety level after port catheter needle replacement [Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Şanlıurfa Mehmet Akif İnan Education and Research Hospital — Sanliurfa

Identifiers

NCT: NCT07679295 · Port

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗