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Completed

NCT Number: NCT07276607

The Effect of Nada Yoga Music and Stress Ball Use on Anxiety and Pain Levels

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.

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Key information

Conditions

Intervention Effectiveness Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ağri İbrahim Çeçen Universty

Ağrı, 04100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between 30 and 65 years of age
  • Having no communication barriers
  • Applying for a Pap smear test
  • Volunteering to participate in the study

Exclusion criteria

  • 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

Treatment and study plan

Nada Yoga Music

Other

Participants listened to Nada Yoga music through headphones for 15 minutes before and 15 minutes after the Pap smear procedure.

Stress Ball group:

Other

Participants were instructed to perform squeeze-release exercises using a medium-firm stress ball during the procedure.

Nada Yoga Music + Stress Ball group

Other

Participants both listened to Nada Yoga music and performed stress ball exercises concurrently.

Primary outcomes

  1. Personal Information Form

    Time frame: Average 8 Years

    It is a form prepared by the researcher based on the relevant literature to assess the sociodemographic characteristics of the participants.

  2. Visual Analog Scale

    Time frame: 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

  3. Spielberger State Anxiety Inventory

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Agri Ibrahim Cecen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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