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Enrolling by Invitation

NCT Number: NCT07679295

Port Catheter Needle Change: Pain, Anxiety and Patient Satisfaction

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.

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Key information

Conditions

Vascular Access Anxiety Disorders Behavior Health Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Şanlıurfa Mehmet Akif İnan Education and Research Hospital

Sanliurfa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Pain intensity after port catheter needle replacement

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

    Numerical Rating Scale The scale used to diagnose pain has numerical values between 0 and 10. The patient is asked to indicate their pain on the scale. During the evaluation, an 11-point scale was used, where "0" represents "no pain" and "10" represents "the most severe pain imaginable".

  2. Patient satisfaction after port catheter needle replacement

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

    Visual Analog Patient Satisfaction Scale The visual patient satisfaction scale (visual analog patient satisfaction scale) overlaps with the characteristics of the VAS. This scale is a vertical straight line between 0 and 10. "0" (Not satisfied at all), "10" (Very satisfied). The patient indicates the point on the vertical line corresponding to their degree of medical satisfaction with a cross mark and is scored out of ten.

  3. State anxiety level after port catheter needle replacement

    Time frame: Data will be collected within 15 minutes after completion of 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.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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