Intervention EffectivenessNCT07276607
The Effect of Nada Yoga Music and Stress Ball Use on Anxiety and Pain Levels
A study testing Nada Yoga Music, Stress Ball group: and Nada Yoga Music + Stress Ball group in people with Intervention Effectiveness, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intervention Effectiveness
- What is being tested?
- Nada Yoga Music, Stress Ball group: and Nada Yoga Music + Stress Ball group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 30 and 65 years of age
- Having no communication barriers
- Applying for a Pap smear test
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağri İbrahim Çeçen Universty
Ağrı, Ağrı, 04100
About this study
Official 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
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.
Read the 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
- Intervention Effectiveness
- Being tested
- Nada Yoga Music, Stress Ball group:, Nada Yoga Music + Stress Ball group
- Keywords
- Pain, anxiety, nada yoga music, pap smear, stress ball
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nada Yoga MusicOther
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 groupOther
Participants both listened to Nada Yoga music and performed stress ball exercises concurrently.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Nada Yoga Music Receives: Other: Nada Yoga Music |
| Group 2 | Experimental | Stress Ball Receives: Other: Stress Ball group: |
| Group 3 | Experimental | Nada Yoga Music + Stress Ball Receives: Other: Nada Yoga Music + Stress Ball group |
| Group 4 | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
It is a form prepared by the researcher based on the relevant literature to assess the sociodemographic characteristics of the participants.
Measured: 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
Measured: 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.
Measured: Average 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intervention EffectivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was a prospective, parallel, randomized controlled trial with pretest, posttest, and follow-up measurements.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
- Investigators
- Nurten Özçalkap, Principal investigator, AĞRI İBRAHİM ÇEÇEN UNIVERSTYSİBEL YÜCETÜRK, Study chair, SİNOP UNIVERSTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276607
- Sponsor's protocol ID
- 2025/73
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
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.
PubMed 30027283
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07276607
- Acronym / sponsor ID
- 2025/73
- Conditions
- Intervention Effectiveness
- Keywords
- Pain, anxiety, nada yoga music, pap smear, stress ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This research was a prospective, parallel, randomized controlled trial with pretest, posttest, and follow-up measurements.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Nada Yoga MusicNada Yoga Music |
| Group 2 | Experimental | Other: Stress Ball group:Stress Ball |
| Group 3 | Experimental | Other: Nada Yoga Music + Stress Ball groupNada Yoga Music + Stress Ball |
| Group 4 | No intervention | –standard care group |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between 30 and 65 years of age
- Having no communication barriers
- Applying for a Pap smear test
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nada Yoga MusicParticipants listened to Nada Yoga music through headphones for 15 minutes before and 15 minutes after the Pap smear procedure. | Other | Group 1 |
| Stress Ball group:Participants were instructed to perform squeeze-release exercises using a medium-firm stress ball during the procedure. | Other | Group 2 |
| Nada Yoga Music + Stress Ball groupParticipants both listened to Nada Yoga music and performed stress ball exercises concurrently. | Other | Group 3 |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Results publication: PubMed 30027283Yanes 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.
- Individual participant dataSharing planned: No. we don't share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurten Özçalkap principal investigator
AĞRI İBRAHİM ÇEÇEN UNIVERSTY
SİBEL YÜCETÜRK study chair
SİNOP UNIVERSTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nada Yoga Music, Stress Ball group: and Nada Yoga Music + Stress Ball group in people with Intervention Effectiveness, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: Average 8 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07276607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.