Clinical Trials Directory

Trials / Completed

CompletedNCT07276607

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
128 (actual)
Sponsor
Inonu University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
OTHERNada Yoga MusicParticipants listened to Nada Yoga music through headphones for 15 minutes before and 15 minutes after the Pap smear procedure.
OTHERStress Ball group:Participants were instructed to perform squeeze-release exercises using a medium-firm stress ball during the procedure.
OTHERNada Yoga Music + Stress Ball groupParticipants both listened to Nada Yoga music and performed stress ball exercises concurrently.

Timeline

Start date
2025-04-01
Primary completion
2025-07-30
Completion
2025-10-31
First posted
2025-12-11
Last updated
2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07276607. Inclusion in this directory is not an endorsement.