Clinical trial · Interventional
The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stress ball | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stress ball group
- description
- 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.
- interventionNames
- Other: Stress ball
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Same steps as above, but no intervention; only routine treatment is provided.
Primary outcomes (1)
- measure
- Distress Thermometer (DT):
- timeFrame
- 1 per month for 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available