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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstanbul University

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

Qualifiers

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

Treatments tested in this trial

  • Stress Ball
  • Empathic Verbal-Tactile Intervention

Treatment groups

122 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators