The Effect of Nada Yoga Music and Stress Ball Use on Anxiety and Pain Levels During Smear Smear Tests in Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Personal Information Form
研究概览
简要总结
This parallel-group randomized controlled trial was conducted between Aprıl 2025 and December 2025 at a Training and Research Hospital in Türkiye among women who applied for Pap smear testing. A total of 128 participants aged 30-56 years were included. Data were collected at three time points using the Personal Information Form, Visual Analog Scale (VAS), and State-Trait Anxiety Inventory (STAI). A mixed-model ANOVA was applied to address the effects of time, group, and time × group interactions. Statistical significance was set at p≤0.05.
详细描述
The study population consisted of women who applied for a Pap smear test at X Training and Research Hospital between Aprıl 2025 and December 2025 . The sample size was calculated using the G*Power 3.1.9.7 software (Faul et al., 2007). Based on a medium effect size (0.25), a two-way mixed-design ANOVA (repeated measures, within-between interaction), an alpha error of 0.05, an inter-measurement correlation of 0.5, and a statistical power of 95% (1-β = 0.95), the minimum required sample size was determined to be 60 (15 per group). The study was completed with a total of 128 voluntary participants, distributed equally across four groups: Nada Yoga Music (n = 32), Stress Ball (n = 32), Nada Yoga Music + Stress Ball (n = 32), and Control (n = 32). The inclusion criteria included being between 30 and 65 years of age, having no communication barriers, applying for a Pap smear test, and volunteering to participate in the study. The exclusion criteria included having any condition preventing music listening (e.g., hearing loss), having any limitation preventing stress ball use (e.g., hand or finger injuries), or having a diagnosed psychiatric disorder (e.g., depression, bipolar disorder).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being between 30 and 65 years of age
- •Having no communication barriers
- •Applying for a Pap smear test
- •Volunteering to participate in the study
排除标准
- •Having any condition that prevents listening to music (e.g., hearing loss)
- •Having any physical limitation that prevents the use of a stress ball
- •Having a diagnosed psychiatric disorder
研究组 & 干预措施
Group 1
Nada Yoga Music
干预措施: Nada Yoga Music (Other)
Group 2
Stress Ball
干预措施: Stress Ball group: (Other)
Group 3
Nada Yoga Music + Stress Ball
干预措施: Nada Yoga Music + Stress Ball group (Other)
Group 4
standard care group
结局指标
主要结局
Personal Information Form
时间窗: Average 8 Years
It is a form prepared by the researcher based on the relevant literature to assess the sociodemographic characteristics of the participants.
Spielberger State Anxiety Inventory
时间窗: Average 8 Years
Spielberger's State-Trait Anxiety Inventory (STAI): Developed in 1964 by Spielberger et al., the State-Trait Anxiety Inventory was designed to measure the state and trait anxiety levels of both normal and clinical populations. The scale was adapted into Turkish by Öner and Le Compte. It is a self-report instrument composed of brief statements. The State Anxiety Inventory (SAI) provides information only about how the individual feels at that specific moment, whereas the Trait Anxiety Inventory (TAI) was developed to assess anxiety experienced over the past seven days. The STAI consists of two subscales, each containing 20 items, rated on a 4-point Likert scale. In a study conducted with both healthy and clinical samples, in 2000 by Aydemir and Köroğlu reported reliability coefficients ranging from .83 to .87.
Personal Information Form
时间窗: Average 8 Years
It is a form prepared by the researcher based on the relevant literature to assess the sociodemographic characteristics of the participants.
Visual Analog Scale
时间窗: Average 8 Years
The Visual Analogue Scale (VAS) was first developed in 1921 by Hayes and Patterson. The standard VAS, as generally accepted, is a semi-quantitative, ordinal scale consisting of a 100-mm line. This scientifically accepted standard length aims to provide an easy and quantitative method of assessment. The VAS was first used as a self-rated tool to measure mood in 1969 by Zealley and Aitken. Studies conducted with VAS in patients experiencing pain have shown that the horizontal format is used more frequently. The VAS is typically defined as a 10-cm line, either horizontal or vertical, starting with "No Pain" and ending with "Unbearable Pain." This line may be presented as a simple straight line or divided into equal segments. When used to assess pain, it may also include descriptive pain labels placed along the line. The VAS has been a successful assessment tool in many studies for determining the effects of treatment. In our study, participants were asked to indicate their pain level o
次要结局
未报告次要终点
研究者
NURTEN ÖZÇALKAP
Asistant Professor
Agri Ibrahim Cecen University