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Clinical Trials/NCT06460974
NCT06460974
Not yet recruiting
Not Applicable

The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer: A Randomized Controlled Study

Mersin University1 site in 1 country74 target enrollmentJune 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients With Breast Cancer
Sponsor
Mersin University
Enrollment
74
Locations
1
Primary Endpoint
General Comfort Scale
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

This research was conducted as a randomized controlled study to determine the effect of stress ball application on stress, anxiety and comfort in women with breast cancer receiving chemotherapy.

Detailed Description

The research was conducted as a randomized controlled study. A total of 74 patients were randomly assigned to the stress ball group (n=37) and the control group (n=37).

Registry
clinicaltrials.gov
Start Date
June 2024
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Birgul Vural Dogru

Associate Professor

Mersin University

Eligibility Criteria

Inclusion Criteria

  • who is literate in Turkish,
  • who was diagnosed with stage 1, 2 and 3 breast cancer
  • who had the second cure or above chemotherapy receiving treatment
  • over 18 years of age
  • platelet level \>50,000 mm3
  • not having any physical problems squeezing a stress ball

Exclusion Criteria

  • those who did not agree to participate in the study
  • those who received chemotherapy for the first time,
  • those who had any physical disability to squeeze a stress ball
  • Any receiving intravenous treatment from both arms,
  • having had a unilateral or bilateral mastectomy and having a problem squeezing a stress ball,
  • having any psychiatric disease,

Outcomes

Primary Outcomes

General Comfort Scale

Time Frame: 6 months

The scale contains a total of 48 items in a four-point Likert type and consists of four sub-dimensions (physical, psycho-spiritual, environmental, and socio-cultural sub-dimensions).

Distress Thermometer

Time Frame: 6 months

Distress level is determined by a visual analog scale ranging from "0-10". Patients express the psychological distress they feel with the numbers on the thermometer; "0 points" means that the patient does not experience any distress, and "10 points" means that the patient experiences the highest level of distress

State-Trait Anxiety Inventory

Time Frame: 6 months

It evaluates the state of anxiety felt by the individual due to the stressful situation he is in. The first 20 items, consisting of short statements, measure the individual's state anxiety level.

Study Sites (1)

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