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

NCT07562828 | Not Yet Recruiting

• 1 other identifier: 2025/67
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Procedural Anxiety; Procedural Pain; Breast Imaging

Outcome Measures

Primary Outcomes (2)

• Anxiety Level

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

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

• 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.

  Immediately after mammography and breast ultrasonography (same day)

Study Arms (3)

Stress Ball Intervention

EXPERIMENTAL

Participants in this group will be provided with a soft, smooth stress ball (approximately 6 cm in diameter) before the imaging procedure. They will be instructed to rhythmically squeeze and relax the ball while waiting for the procedure and to continue its use during breast ultrasonography.

Behavioral: Stress Ball

Empathic Verbal Communication with Therapeutic Touch

EXPERIMENTAL

Participants in this group will be guided to a quiet waiting area where trained researchers will deliver standardized empathic verbal statements. Simultaneously, gentle therapeutic touch will be applied by placing a hand on the participant's shoulder to provide reassurance and emotional support prior to the procedure.

Behavioral: Empathic Verbal-Tactile Intervention

Control (Routine Care)

NO INTERVENTION

Participants in the control group will receive routine clinical care without any additional intervention beyond standard practice.

Interventions

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.

Stress Ball Intervention

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.

Empathic Verbal Communication with Therapeutic Touch

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• No sensory or motor impairment affecting the upper extremities (hands/arms)
• Willing to participate and able to provide written informed consent

You may not qualify if:

• 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
• Refusal to participate or inability to provide informed consent

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of Stress Ball Use and Empathic Verbal Communication with Therapeutic Touch on Anxiety and Pain Perception in Women Undergoing Mammography and Breast Ultrasonography: A Randomized Controlled Trial

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04