[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657897":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":57,"overallOfficials":63,"centralContacts":67,"locations":76,"responsibleParty":91,"collaborators":39,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":39,"eligibilityCriteria":100,"healthyVolunteers":97,"sex":101,"minAge":102,"maxAge":39,"enrollmentInfo":103,"targetDuration":39,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":79,"whyStopped":39,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"TC Erciyes University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Score Assessed by Visual Analog Scale (VAS)","Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.","Immediately after the biopsy procedure",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)","Situational anxiety will be assessed using the State Anxiety Scale (STAI-S). Scores range from 20 to 80, with higher scores reflecting higher anxiety levels.","Baseline (before the procedure) and immediately after the biopsy procedure",{"measure":19,"description":20,"timeFrame":12},"Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)","General anxiety disposition will be assessed using the Trait Anxiety Scale (STAI Form TX-2 \u002F STAI-T). The total score ranges from 20 to 80, with higher scores reflecting higher levels of trait anxiety.",{"measure":22,"description":23,"timeFrame":17},"Changes in Vital Signs (Body Temperature)","Body temperature (°C) will be recorded.",{"measure":25,"description":26,"timeFrame":17},"Changes in Vital Signs (Heart Rate)","Heart rate will be recorded in beats per minute (bpm).",{"measure":28,"description":29,"timeFrame":17},"Changes in Vital Signs (Respiratory Rate)","Respiratory rate will be recorded in breaths per minute.",{"measure":31,"description":32,"timeFrame":17},"Changes in Vital Signs (Systolic Blood Pressure)","Systolic blood pressure (mmHg) will be recorded.",{"measure":34,"description":35,"timeFrame":17},"Changes in Vital Signs (Diastolic Blood Pressure)","Diastolic blood pressure (mmHg) will be recorded.",{"measure":37,"description":38,"timeFrame":17},"Changes in Vital Signs (Peripheral Oxygen Saturation)","Peripheral oxygen saturation (SpO2, %) will be recorded.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Stress Ball","EXPERIMENTAL","Participants in this group will squeeze a stress ball during the breast biopsy procedure.",[52],"Behavioral: Using a Stress Ball",{"label":54,"type":55,"description":56,"interventionNames":39},"Routine Care","NO_INTERVENTION","Participants will receive standard care without any stress ball application.",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":39},"BEHAVIORAL","Using a Stress Ball","Participants will squeeze a stress ball during the biopsy procedure",[48],[64],{"name":65,"affiliation":5,"role":66},"Evrim Bayraktar, Assoc. Prof. Dr.","STUDY_DIRECTOR",[68,72],{"name":65,"role":69,"phone":70,"phoneExt":39,"email":71},"CONTACT","+905332156825","ealbayrak@erciyes.edu.tr",{"name":73,"role":69,"phone":74,"phoneExt":39,"email":75},"Meryem Tuğba Ton, RN, BSN","+905078781249","meryemtubaton@gmail.com",[77],{"facility":78,"status":79,"city":80,"state":39,"zip":39,"country":81,"countryCode":39,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Erciyes University Faculty of Medicine Hospitals","RECRUITING","Kayseri","Turkey (Türkiye)",{"type":83,"coordinates":84},"Point",[85,86],35.48528,38.73222,{"lat":86,"lon":85},[89],{"name":65,"role":69,"phone":90,"phoneExt":39,"email":71},"+90 352 437 9281",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Meryem Tugba Ton","Nurse","100657897","the-effect-of-using-a-stress-ball-on-pain-anxiety-and-vital-signs-during-breast-biopsy-100657897",false,"NCT07844395","The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy","Inclusion Criteria:\n\n* Scheduled for Tru-Cut breast biopsy\n* Aged 18 years and older\n* Undergoing breast biopsy for the first time\n* Able to speak Turkish\n* Female sex\n* Not pregnant\n* Not breastfeeding\n* No cognitive, verbal, or hearing impairments that could impede communication\n* Voluntarily agreeing to participate in the study with written and verbal informed consent\n\nExclusion Criteria:\n\n* Chronic pain disorders or regular use of analgesics\n* Having taken analgesic medication on the day of the procedure\n* Inability to use the hands or impaired grip\u002Fgrasp function","FEMALE","18 Years",{"count":104,"type":105},53,"ESTIMATED","INTERVENTIONAL",[108],"NA","Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Therefore, non-pharmacological nursing interventions that are simple, low-cost, and easy to implement may be useful in managing procedural distress.\n\nThis study aims to investigate the effect of stress ball use during breast biopsy on patients' pain, anxiety, and vital signs. Participants will be assigned to an intervention group using a stress ball during the biopsy procedure or a control group receiving standard care. Pain and anxiety levels, as well as vital signs, will be assessed and compared between the two groups.",[111,112,113,114],"Breast Biopsy","Procedural Pain","Anxiety","Vital Signs",[116,117,118],"stress ball","distraction","nursing intervention","2026-09-21",{"date":121,"type":122},"2026-09-28","ACTUAL",{"date":124,"type":122},"2026-09-11",{"date":126,"type":105},"2026-10-31",{"name":5,"class":6},1]