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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Stress Ball

    Behavioral

    Participants 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

    Behavioral

    Empathic 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

122 Participants
are divided into 3 treatment groups
Group A: Stress Ball InterventionExperimental treatment 1 intervention
Group B: Empathic Verbal Communication with Therapeutic TouchExperimental treatment 1 intervention
Group C: Control (Routine Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Anxiety Level

Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Higher scores indicate higher levels of anxiety

Time frame
Immediately before and immediately after mammography and breast ultrasonography (same day)
2

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.

Time frame
Immediately after mammography and breast ultrasonography (same day)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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