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

NCT06522503 | Completed

• 1 other identifier: SB
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

cancer patient; perceived stress; pain; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pain level

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

Other Outcomes (1)

• patient satisfaction level

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

Study Arms (2)

intervention

EXPERIMENTAL

Behavioral: stress ball

control

NO INTERVENTION

Interventions

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Ayşegül Çelik

Izmir, Menemen, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

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

Study Officials

• Aslıhan Öztürk Çetin, MSc

  Izmir Bakircay University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof., RN, MSc, PhD

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 26, 2024
• Study Start: January 1, 2024
• Primary Completion: July 29, 2024
• Study Completion: July 31, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)