About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female participants aged 18 years and older
Scheduled to undergo mammography and breast ultrasonography
Undergoing these imaging procedures for the first time
Literate (able to read and understand study materials)
Disqualifiers
Previous experience of mammography or breast ultrasonography
Presence of any cognitive impairment that may affect understanding or communication
Presence of any physical disability that may interfere with participation
Hearing or visual impairment that may hinder communication or completion of study procedures
Trial design
Parallel
Treatments tested in this trial
Stress Ball
BehavioralParticipants will be provided with a soft, smooth stress ball (approximately 6 cm in diameter) prior to the imaging procedure. They will be instructed to rhythmically squeeze and release the ball while waiting for mammography and to continue using it during breast ultrasonography until the procedure is completed.
Empathic Verbal-Tactile Intervention
BehavioralEmpathic Verbal Communication with Therapeutic Touch (Behavioral) Participants will be taken to a quiet waiting area before the procedure. Trained researchers will deliver standardized empathic verbal statements to provide reassurance and emotional support. At the same time, gentle therapeutic touch will be applied by placing a hand on the participant's shoulder. The intervention will be administered prior to the imaging procedure.
Treatment groups
Trial outcomes
Primary outcomes
Anxiety Level
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Higher scores indicate higher levels of anxiety
Pain Intensity
Pain intensity will be evaluated using a Numerical Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
Locations
Sponsors and contacts
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