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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 主要终点
- Anxiety Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Stress Ball (Behavioral)
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.
干预措施: Empathic Verbal-Tactile Intervention (Behavioral)
Control (Routine Care)
Participants in the control group will receive routine clinical care without any additional intervention beyond standard practice.
结局指标
主要结局
Anxiety Level
时间窗: Immediately before and immediately after mammography and breast ultrasonography (same day)
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Higher scores indicate higher levels of anxiety
Pain Intensity
时间窗: Immediately after mammography and breast ultrasonography (same day)
Pain intensity will be evaluated using a Numerical Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
次要结局
未报告次要终点
研究者
Betül Güven
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
Istanbul University