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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Procedural Pain; Procedural Anxiety; Breast Imaging
• Intervention / Treatment: Behavioral: Stress Ball; Behavioral: Empathic Verbal-Tactile Intervention

Detailed Description

This study is designed as a prospective, parallel-group randomized controlled trial to examine the effects of stress ball use and empathic verbal communication combined with therapeutic touch on anxiety levels and pain perception in women undergoing mammography and breast ultrasonography. The research will be carried out between May and September 2026 at Istanbul Bakırköy Dr. Sadi Konuk Training and Research Hospital.

Prior to participant recruitment, all necessary ethical approvals will be secured. Eligible women presenting for mammography and breast ultrasonography will be informed about the study purpose, procedures, and voluntary nature of participation, and written informed consent will be obtained. Inclusion criteria consist of being 18 years of age or older, undergoing these imaging procedures for the first time, being literate, and having no sensory or motor impairment affecting the upper extremities. Women with previous experience of these procedures, as well as those with cognitive, physical, visual, or hearing impairments, will be excluded.

The sample size was determined as 122 participants based on a 95% confidence level and 5% margin of error. Participants will be allocated into three groups in a 1:1:1 ratio: stress ball group (n=41), empathic verbal communication with therapeutic touch group (n=41), and control group (n=40).

Randomization and Allocation Procedure Participants will be randomized individually on the day of their scheduled mammography and breast ultrasonography appointments. After confirming eligibility and obtaining written informed consent, participants will be assigned to one of three groups (stress ball, empathic verbal communication with therapeutic touch, or control) using a computer-generated randomization sequence.

Block randomization with a 1:1:1 allocation ratio will be used to ensure balanced group sizes throughout the study period. The randomization list will be prepared in advance by an independent researcher who is not involved in recruitment, intervention delivery, or data collection.

To maintain allocation concealment, group assignments will be placed in sequentially numbered, opaque, sealed envelopes. These envelopes will be opened only after participant enrollment, in the order of inclusion.

Randomization will be implemented continuously on a daily basis as participants present for their scheduled appointments, ensuring that group assignment remains unpredictable and independent of appointment timing.

Due to the nature of the interventions, blinding of participants and intervention providers is not feasible. However, outcome data will be collected using standardized and validated self-report instruments to minimize bias.

Intervention Procedures Participants assigned to the stress ball group will be provided with a soft, smooth stress ball (6 cm in diameter) and instructed to repeatedly squeeze and relax it while waiting for the procedure and during ultrasonography.

Participants in the empathic verbal communication with therapeutic touch group will be taken to a quiet waiting area. Trained researchers will use predefined empathic statements and simultaneously apply gentle touch by placing a hand on the participant's shoulder.

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

Data Collection and Outcomes Data will be collected immediately before and after the imaging procedures. A Descriptive Characteristics Form will be used to obtain sociodemographic and clinical information. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), and pain intensity will be measured using a Numerical Rating Scale ranging from 0 (no pain) to 10 (worst possible pain).

The primary aim of the study is to evaluate the effectiveness of these non-pharmacological interventions in reducing anxiety and perceived pain during breast imaging procedures.

Data Analysis Statistical analyses will be conducted using statistical software. Descriptive statistics will summarize baseline characteristics. Between-group differences in anxiety and pain scores will be assessed using appropriate tests based on data distribution (e.g., one-way ANOVA or Kruskal-Wallis test), while within-group changes will be analyzed using paired comparisons. Post hoc analyses will be performed where applicable. Statistical significance will be set at p < 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Ball Intervention; 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; 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.
Experimental: Empathic Verbal Communication with Therapeutic Touch; 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; 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.
No Intervention: Control (Routine Care); Participants in the control group will receive routine clinical care without any additional intervention beyond standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural
• Other Study ID Numbers: 2025/67

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No