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

NCT ID: NCT07276607

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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

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Intervention Effectiveness

Keywords

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Pain anxiety nada yoga music pap smear stress ball

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research was a prospective, parallel, randomized controlled trial with pretest, posttest, and follow-up measurements.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group 1

Nada Yoga Music

Group Type EXPERIMENTAL

Nada Yoga Music

Intervention Type OTHER

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

Group 2

Stress Ball

Group Type EXPERIMENTAL

Stress Ball group:

Intervention Type OTHER

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

Group 3

Nada Yoga Music + Stress Ball

Group Type EXPERIMENTAL

Nada Yoga Music + Stress Ball group

Intervention Type OTHER

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

Group 4

standard care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nada Yoga Music

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

Intervention Type OTHER

Stress Ball group:

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

Intervention Type OTHER

Nada Yoga Music + Stress Ball group

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Agri Ibrahim Cecen University

OTHER

Sponsor Role collaborator

Inonu University

OTHER

Sponsor Role lead

Responsible Party

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nurten özçalkap

Asistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten Özçalkap

Role: PRINCIPAL_INVESTIGATOR

AĞRI İBRAHİM ÇEÇEN UNIVERSTY

SİBEL YÜCETÜRK

Role: STUDY_CHAIR

SİNOP UNIVERSTY

Locations

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Ağri İbrahim Çeçen Universty

Ağrı, Ağrı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.

Reference Type RESULT
PMID: 30027283 (View on PubMed)

Other Identifiers

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2025/73

Identifier Type: -

Identifier Source: org_study_id