[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":24,"collaborators":18,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":18,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":49,"overallStatus":55,"whyStopped":18,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":18},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stress ball group","EXPERIMENTAL","Stress Ball Group\n\nFirst Interview: Consent is obtained; group allocation is done.\n\nPre-test: Patient information form, DT, STAI, and vital signs are assessed.\n\nIntervention: Stress ball use for 15-20 minutes during chemotherapy.\n\nPost-test: Same measurements are repeated.",[13],"Other: Stress ball",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Same steps as above, but no intervention; only routine treatment is provided.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Stress ball","First Interview: Consent is obtained; group allocation is done.\n\nPre-test: Patient information form, DT, STAI, and vital signs are assessed.\n\nIntervention: Stress ball use for 15-20 minutes during chemotherapy.\n\nPost-test: Same measurements are repeated.",[9],{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":28,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Bedriye Cansu DEMİRKIRAN","assistant professor","Ataturk Training and Research Hospital","100598489","the-effect-of-stress-ball-use-on-stress-anxiety-and-vital-signs-in-patients-undergoing-chemotherapy-for-breast-cancer-100598489",false,"NCT07072156","The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer","Stressball","Inclusion Criteria:\n\n* Stage 2A-2B breast cancer\n* Receiving neoadjuvant chemotherapy\n* On a chemotherapy protocol administered every 21 days\n* Receiving second or subsequent chemotherapy cycle\n* No migraine, vertigo, active nausea, vomiting, or headache\n* No history of seizures\n* No primary or metastatic brain cancer\n* No visual, hearing, or cognitive impairment\n* Age 18 or older\n* No communication barriers\n* Voluntary participation\n\nExclusion Criteria:\n\n* Cancer types other than breast cancer\n* Unilateral or bilateral mastectomy\n* Any condition preventing hand use (e.g., pain, fracture, open wound)\n* IV access in both arms\n* Psychiatric diagnosis\n* Diagnosed anxiety disorder or current anti-anxiety medication use","ALL","18 Years","90 Years",{"count":40,"type":41},50,"ESTIMATED","INTERVENTIONAL",[44],"NA","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.\n\nMETHOD 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.\n\nORIGINALITY \u002F 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.\n\nEXPECTED 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.",[47,48],"Chemotherapy","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[50,51,52,53,54],"Stress Ball","breast cancer","stress","Anxiety","Vital Signs","NOT_YET_RECRUITING","2025-07-16",{"date":58,"type":59},"2025-07-18","ACTUAL",{"date":61,"type":41},"2025-08-01",{"date":63,"type":41},"2026-12-01",{"name":5,"class":6}]