Clinical Trial

Stress Ball and Empathic Verbal-Tactile Interventions for Reducing Anxiety and Pain in Mammography and Breast Ultrasonography: A Randomized Trial

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Summary
This prospective, randomized controlled trial aims to determine the effects of stress ball use and empathic verbal communication with therapeutic touch on anxiety and pain perception in women undergoing mammography and breast ultrasonography. The study will be conducted between May and September 2026 at Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital. A total of 122 women meeting the inclusion criteria will be randomly assigned into three groups: stress ball group (n=41), empathic verbal communication with touch group (n=41), and control group (n=40). Women in the stress ball group will be instructed to use a soft stress ball before and during the procedure. Participants in the empathic verbal-tactile group will receive structured verbal empathy combined with therapeutic touch. The control group will receive routine care without additional intervention. Data will be collected before and after the procedures using a Descriptive Characteristics Form, the State-Trait Anxiety Inventory, and a Numerical Rating Scale for pain assessment. The findings of this study are expected to provide evidence on the effectiveness of non-pharmacological interventions in reducing anxiety and pain during breast imaging procedures.
Trial Details
NCT Number NCT07562828
Lead Sponsor Istanbul University
Conditions Procedural Anxiety, Procedural Pain, Breast Imaging
Enrollment 122 participants
Start Date 2026-05-04
Primary Completion 2026-09-14 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-01