The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ataturk University
- Enrollment
- 50
- Primary Endpoint
- Distress Thermometer (DT):
Study Overview
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.
Detailed Description
METHOD This study is planned as a single-blind, randomized controlled experimental design. It will be conducted with breast cancer patients receiving chemotherapy at Rize Training and Research Hospital's Chemotherapy Unit.
POPULATION AND SAMPLE The study population consists of breast cancer patients receiving chemotherapy at the aforementioned hospital during the research period. Since no previous study has evaluated the effect of stress ball use on stress, anxiety, and vital signs in this population, the sample size was calculated using Cohen's large effect size (d = 0.80) via the G*Power 3.1.9.7 program. With α = 0.05 and power = 80%, the minimum required sample size was found to be 42. To account for possible data loss, 20% more participants will be included. Therefore, 25 patients will be assigned to each group, totaling 50 participants. The study will be reported in accordance with the CONSORT guidelines for randomized controlled trials.
INCLUSION CRITERIA Stage 2A-2B breast cancer
Receiving neoadjuvant chemotherapy
On a chemotherapy protocol administered every 21 days
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Stress ball group
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.
Intervention: Stress ball (Other)
Control Group
Same steps as above, but no intervention; only routine treatment is provided.
Outcomes
Primary Outcomes
Distress Thermometer (DT):
Time Frame: 1 per month for 3 months
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.
Secondary Outcomes
- State Anxiety Inventory (STAI):(1 per month for 3 months)
Investigators
Bedriye Cansu DEMİRKIRAN
assistant professor
Ataturk Training and Research Hospital