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

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.

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