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

NCT07562828 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-01

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2026-09-14
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562828 on ClinicalTrials.gov