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

NCT07276607 | Completed

• 1 other identifier: 2025/73
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intervention Effectiveness

Keywords

Pain; anxiety; nada yoga music; pap smear; stress ball

Outcome Measures

Primary Outcomes (3)

• Personal Information Form

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

  Average 8 Years

• Visual Analog Scale

  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

  Average 8 Years

• Spielberger State Anxiety Inventory

  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.

  Average 8 Years

Study Arms (4)

Group 1

EXPERIMENTAL

Nada Yoga Music

Other: Nada Yoga Music

Group 2

EXPERIMENTAL

Stress Ball

Other: Stress Ball group:

Group 3

EXPERIMENTAL

Nada Yoga Music + Stress Ball

Other: Nada Yoga Music + Stress Ball group

Group 4

NO INTERVENTION

standard care group

Interventions

Nada Yoga Music OTHER

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

Group 1

Stress Ball group: OTHER

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

Group 2

Nada Yoga Music + Stress Ball group OTHER

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

Group 3

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: "Women undergoing a cervical cancer screening test (Pap smear)"
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agri Ibrahim Cecen University: lead

Study Sites (1)

Ağri İbrahim Çeçen Universty

Ağrı, Ağrı, 04100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30027283 RESULT

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Nurten Özçalkap

  AĞRI İBRAHİM ÇEÇEN UNIVERSTY

  PRINCIPAL INVESTIGATOR

• SİBEL YÜCETÜRK

  SİNOP UNIVERSTY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Model Details: This research was a prospective, parallel, randomized controlled trial with pretest, posttest, and follow-up measurements.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: April 1, 2025
• Primary Completion: July 30, 2025
• Study Completion: October 31, 2025
• Last Updated: April 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)