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

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

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

WITHDRAWAL CRITERIA Patient requests to withdraw

Change in institution or city

Any illness developed during the intervention

Patient's death

RANDOMIZATION Patients meeting inclusion criteria and consenting to participate will be randomized into two groups using simple randomization via Excel's RAND function. Patients assigned even numbers will be placed in the stress ball group, and those with odd numbers in the control group.

BLINDING To minimize bias, both the researcher and the statistician will be blinded. Randomization will be performed by a researcher not involved in data collection. While the researcher administering the intervention will be aware of group allocation, data entry into SPSS will label groups as "Group 1" and "Group 2" without revealing the group type to the statistician.

IMPLEMENTATION OF THE RESEARCH Fifty eligible and consenting patients will be selected. After collecting pre-test data (prior to chemotherapy), patients in the intervention group will receive a stress ball following premedication. They will be instructed to focus on and squeeze the ball for 15-20 minutes during chemotherapy. The control group will continue with routine treatment and care. Post-test data will be collected after the chemotherapy session.

STRESS BALL DETAILS The stress ball is made of high-quality silicone, regaining its shape after squeezing. The ball used in this study is medium firmness (blue), elliptical, and 6 cm in diameter, suitable for adult use. Patients will be taught how to use the stress ball, including coordinated breathing techniques (inhale when squeezing, exhale when releasing). Stress balls will be given to intervention group patients to keep. Control group patients may request a ball after the study concludes.

DATA COLLECTION TOOLS Data will be collected using the Breast Cancer Patient Information Form, Distress Thermometer, and State Anxiety Inventory. Pre- and post-chemotherapy session measurements are planned.

Breast Cancer Patient Information Form:

Includes 11 items regarding age, marital status, education, economic status, employment, smoking and alcohol use, disease duration and stage, presence of chronic illness, and family history of cancer.

Distress Thermometer (DT):

Assess psychosocial distress in cancer patients. It uses a scale from 0 (no distress) to 10 (extreme distress). Scores ≥4 are considered clinically significant. Turkish validity and reliability studies were conducted by Özalp et al.

State Anxiety Inventory (STAI):

This study uses the state anxiety subscale to assess anxiety triggered by specific situations. It consists of 20 items scored on a 4-point Likert scale, where total scores range from 20 to 80. Higher scores indicate greater anxiety.

DATA ANALYSIS Data will be analyzed using SPSS version 26. Descriptive statistics (number, percentage, mean, standard deviation) will be used. For within-group comparisons: paired samples t-test (normal distribution) or Wilcoxon test (non-normal). For between-group comparisons: independent samples t-test (normal) or Mann-Whitney U test (non-normal). A p-value of \<0.05 will be considered statistically significant.

STUDY FLOWCHART SUMMARY 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.

• State Anxiety Inventory (STAI): [Срок оценки: 1 per month for 3 months]