- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07613736
Effect of Stress Ball Use on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-cut Biopsy (STRESS-BX)
The Effect of Stress Ball Application on Pain, Anxiety, and Vital Signs During Ultrasound-Guided Tru-Cut Biopsy Procedures: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of stress ball application on pain, anxiety, and vital signs in adult patients undergoing ultrasound-guided tru-cut biopsy procedures. Tru-cut biopsy is a commonly performed invasive diagnostic procedure that may cause procedural pain and anxiety despite standard local anesthesia. Nonpharmacological interventions such as distraction techniques may improve patient comfort during the procedure.
Participants are randomly assigned to either an intervention group receiving a stress ball application during the biopsy procedure or a control group receiving standard care alone. Pain intensity is assessed using the Visual Analog Scale (VAS), anxiety levels are evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I), and vital signs are recorded before and after the procedure.
The study is conducted at a single tertiary care training and research hospital and includes 79 adult participants. The primary objective of the study is to determine whether stress ball use reduces procedural pain and anxiety during Tru-Cut biopsy procedures. Secondary outcomes include changes in systolic blood pressure, diastolic blood pressure, heart rate, and procedure duration.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
A Tru-cut biopsy is a minimally invasive diagnostic procedure frequently used to evaluate suspicious lesions and tissue abnormalities. Although local anesthesia is routinely administered, patients commonly experience procedural pain, anxiety, and physiological stress responses during the procedure. Increased anxiety levels may negatively influence pain perception, procedural tolerance, and overall patient experience.
Nonpharmacological interventions have increasingly gained attention as supportive approaches for reducing pain and anxiety during invasive procedures. Among these interventions, distraction techniques are considered practical, low-cost, and easy to implement in clinical settings. Stress ball application is a simple distraction-based intervention that encourages active patient participation and may help redirect attention away from the procedure.
This study was designed as a prospective, single-center, parallel-group randomized controlled trial to evaluate the effect of stress ball application on pain, anxiety, and vital signs during ultrasound-guided Tru-Cut biopsy procedures. Participants were randomly assigned in a 1:1 ratio to either the intervention group, which received stress ball application during the procedure, or the control group, which received standard care alone.
Pain intensity was assessed using the Visual Analog Scale (VAS), and anxiety levels were evaluated using the State-Trait Anxiety Inventory (STAI Form TX-I). Vital signs, including systolic and diastolic blood pressure and heart rate, were recorded before and after the procedure. The study aimed to determine whether the use of stress balls could reduce procedural pain and anxiety and improve physiological responses during Tru-Cut biopsy procedures.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye), 34000
- Bakirkoy Dr. Sadi Konuk Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
Aged 18 years or older Scheduled for an ultrasound-guided tru-cut biopsy procedure Conscious and able to communicate Able to understand and respond to the study forms Provided written informed consent Patients with or without previous biopsy experience
Exclusion Criteria:
Received sedation prior to the procedure Had cognitive impairment or communication difficulties Had upper extremity limitations preventing stress ball use Experienced complications during the procedure Refused to participate in the study
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Experimental: Stress Ball Application
Experimental Arm Description Participants in the experimental group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to standard care. Patients were instructed to squeeze the stress ball continuously throughout the procedure as a distraction-based nonpharmacological intervention. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure. Control Arm Description Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure. No additional nonpharmacological intervention was applied. Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure. |
Participants in the intervention group received stress ball application during the ultrasound-guided tru-cut biopsy procedure in addition to routine standard care.
Patients were instructed to continuously squeeze a medium-resistance stress ball throughout the procedure as a distraction-based nonpharmacological intervention aimed at reducing procedural pain and anxiety.
The intervention was applied only during the biopsy procedure, and no pharmacological or additional behavioral intervention was administered as part of the study.
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Nessun intervento: No Intervention: Standard Care
Participants in the control group received routine standard care during the ultrasound-guided tru-cut biopsy procedure.
No additional nonpharmacological intervention or distraction technique was applied.
Pain intensity, anxiety levels, and vital signs were assessed before and after the procedure.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Post-procedural Pain Intensity
Lasso di tempo: Immediately after the procedure
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Pain intensity assessed after the ultrasound-guided tru-cut biopsy procedure using the Visual Analog Scale (VAS).
Higher scores indicate greater pain intensity.
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Immediately after the procedure
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Change in State Anxiety Level
Lasso di tempo: Before and immediately after the procedure
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Change in anxiety level measured using the State-Trait Anxiety Inventory Form TX-I (STAI) before and after the ultrasound-guided tru-cut biopsy procedure.
Higher scores indicate higher anxiety levels
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Before and immediately after the procedure
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Collaboratori e investigatori
Sponsor
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/39
- BSKEAH-2026-39 (Altro identificatore: Bakirkoy Dr. Sadi Konuk Training and Research Hospital)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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