The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer

NCT07072156 | Not Yet Recruiting

• 1 other identifier: Stresballbreastca
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

AIM This study aims to investigate the effects of stress ball use on stress, anxiety, and vital signs in patients receiving chemotherapy for breast cancer. METHOD This study will be conducted with 50 breast cancer patients receiving chemotherapy at the Outpatient Chemotherapy Unit of Rize Training and Research Hospital, using a randomized controlled experimental design. Simple randomization will be used for group assignment. Data will be collected using a Breast Cancer Patient Information Form, Distress Thermometer, and State Anxiety Inventory. It is planned that data will be collected both before and after the chemotherapy session. ORIGINALITY / SCIENTIFIC CONTRIBUTION To date, no study has been found in the literature evaluating the effects of stress balls on stress, anxiety, and vital signs in breast cancer patients undergoing chemotherapy. Therefore, this project is considered original and is expected to contribute to both national and international scientific literature. If successful, the project will provide evidence for a new non-pharmacological intervention that is easy to use during chemotherapy sessions and can help improve patients' stress, anxiety, and vital signs. Patients may experience more comfort and better treatment compliance during chemotherapy. EXPECTED OUTCOMES It is expected that the use of a stress ball will have a positive effect on reducing stress and anxiety levels and improving vital signs in breast cancer patients receiving chemotherapy.

Conditions

Chemotherapy; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Stress Ball; breast cancer; stress; Anxiety; Vital Signs

Outcome Measures

Primary Outcomes (1)

• Distress Thermometer (DT):

  It assesses the state anxiety an individual feels due to the stressful situation they are in, their predisposition to this anxiety, and the trait anxiety that generally characterizes the situations they find themselves in as stressful. The total score on the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.

  1 per month for 3 months

Secondary Outcomes (1)

• State Anxiety Inventory (STAI):

  1 per month for 3 months

Study Arms (2)

Stress ball group

EXPERIMENTAL

Stress Ball Group First Interview: Consent is obtained; group allocation is done. Pre-test: Patient information form, DT, STAI, and vital signs are assessed. Intervention: Stress ball use for 15-20 minutes during chemotherapy. Post-test: Same measurements are repeated.

Other: Stress ball

Control Group

NO INTERVENTION

Same steps as above, but no intervention; only routine treatment is provided.

Interventions

Stress ball OTHER

First Interview: Consent is obtained; group allocation is done. Pre-test: Patient information form, DT, STAI, and vital signs are assessed. Intervention: Stress ball use for 15-20 minutes during chemotherapy. Post-test: Same measurements are repeated.

Stress ball group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 2A-2B breast cancer
• Receiving neoadjuvant chemotherapy
• On a chemotherapy protocol administered every 21 days
• Receiving second or subsequent chemotherapy cycle
• No migraine, vertigo, active nausea, vomiting, or headache
• No history of seizures
• No primary or metastatic brain cancer
• No visual, hearing, or cognitive impairment
• Age 18 or older
• No communication barriers
• Voluntary participation

You may not qualify if:

• Cancer types other than breast cancer
• Unilateral or bilateral mastectomy
• Any condition preventing hand use (e.g., pain, fracture, open wound)
• IV access in both arms
• Psychiatric diagnosis
• Diagnosed anxiety disorder or current anti-anxiety medication use

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Stress Ball Group First Interview: Consent is obtained; group allocation is done. Pre-test: Patient information form, DT, STAI, and vital signs are assessed. Intervention: Stress ball use for 15-20 minutes during chemotherapy. Post-test: Same measurements are repeated.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 18, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL