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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: stress ball

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Menemen
    • Izmir, Menemen, Turkey, 35665
      • Ayşegül Çelik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: intervention	Behavioral: stress ball; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perceived stress level	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.	baseline and end of the port catheterisation procedure (mean time 10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain level	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.	End of the port catheterisation procedure (mean time 10 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction level	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.	End of the port catheterisation procedure (mean time 10 minutes)

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Investigators: Study Chair: Aslıhan Öztürk Çetin, MSc, Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pain; patient satisfaction; perceived stress; cancer patient
• Other Study ID Numbers: SB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No