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Completed

NCT Number: NCT06522503

Effect of Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients

The objective of this study was to ascertain the impact of stress ball utilisation on perceived stress, pain and satisfaction levels during port catheter intervention in cancer patients. In this study, which was conducted in a randomised controlled design, a control group of cancer patients receiving chemotherapy (n=37) was assigned to receive standard care during port catheter needle insertion. An intervention group (n=37) was also formed, comprising patients who received stress ball application in addition to standard care. The intervention group was provided with a stress ball in both hands five minutes prior to the insertion of the port catheter needle and instructed to squeeze the ball in their hands at regular intervals until the conclusion of the procedure. Prior to the application, the descriptive characteristics of both groups were ascertained, and their perceived stress levels were assessed. Subsequently, the pain and perceived stress levels of both groups were documented. Additionally, the satisfaction levels of the intervention group regarding the stress ball application were evaluated.

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Key information

Conditions

Cancer Behavior Health Behavior Neoplasms 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

Ayşegül Çelik

Izmir, Menemen, 35665, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years and older
  • Diagnosed with cancer
  • Undergoing active chemotherapy
  • Willing to participate in the research .

Exclusion criteria

  • Communication difficulties
  • Complaints of peripheral neuropathy
  • Refusal to participate in the research

Treatment and study plan

stress ball

Behavioral

The intervention group was provided with a stress ball to be held in both hands for a period of five minutes prior to the insertion of the port catheter needle. They were instructed to squeeze the ball in their hands at regular intervals until the conclusion of the procedure.

Primary outcomes

  1. perceived stress level

    Time frame: baseline and end of the port catheterisation procedure (mean time 10 minutes)

    Perceived Stress Scale: The Perceived Stress Scale, comprising a total of 14 items, has been developed to assess the degree to which an individual perceives specific circumstances in their life as stressful. The scale is a 5-point Likert-type scale, with each item ranging from "Never (0)" to "Very often (4)". The total score obtained from the scale is indicative of the individual's stress level.

Secondary outcomes

  1. pain level

    Time frame: End of the port catheterisation procedure (mean time 10 minutes)

    The Visual Analogue Scale (VAS): The Visual Analogue Scale is a frequently employed instrument for the assessment of pain intensity. It is a unidimensional scale with a length of 0-10 cm. The scale is anchored at 0 cm, which is defined as no pain, and 10 cm, which is defined as unbearable pain. As the score obtained from the scale increases, the pain intensity also increases.

Other outcomes

  1. patient satisfaction level

    Time frame: End of the port catheterisation procedure (mean time 10 minutes)

    Visual Analog Scale-Satisfaction Level (VAS): The Visual Analogue Scale (VAS), comprising a 10-cm line, represents a valid and reliable instrument for measuring subjective emotions such as mood. In this study, a visual analogue scale (VAS) was employed as a means of evaluating patient satisfaction levels.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

The Effect of a Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients: A Distraction-Based Intervention

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Nov 13, 2024

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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