The Effect of Stress Ball Application on Stress, Anxiety and Comfort During Chemotherapy in Women With Breast Cancer

June 11, 2024 updated by: Birgul Vural Dogru, Mersin University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Mersin, Turkey, 33110
        • Mersin University
        • Contact:
        • Sub-Investigator:
          • Hatice ŞİMŞEK, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • female
  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stress ball group
A stress ball was applied to the patients in the stress ball group during chemotherapy treatment
Other: stress ball
A stress ball was applied to the patients in the during chemotherapy treatment.
No Intervention: Control group
Standard care without any additional application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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.
6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Investigators

  • Principal Investigator: Birgül VURAL DOĞRU, Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-HF-BVD-02

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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