Maternal AnxietyNCT07452861
Ney Music During Non-Stress Test and Maternal Anxiety
A study testing Ney Music in people with Maternal Anxiety and Stress, run by Hediye Karakoç at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Anxiety, Stress
- What is being tested?
- Ney Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 30 Aug 2024
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ≥18 years,
- gestational age ≥32 weeks,
- singleton pregnancy,
- absence of known fetal cardiovascular anomalies,
- no visual or hearing impairments,
- having eaten at least two hours before the NST,
- bladder emptied prior to the procedure,
- voluntary participation.
Who cannot join
- pre-existing maternal medical conditions (hypertension, diabetes, obesity),
- multiple pregnancy,
- smoking,
- known fetal abnormalities or fetal distress,
- inherited anemia or sexually transmitted infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ney Music During the Non-Stress Test on Maternal State Anxiety, Autonomic Regulation, and Fetal Reactivity: A Randomized Controlled Trial
This randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. A total of 126 pregnant women at ≥32 weeks' gestation were randomly assigned to either an intervention group (ney music during NST) or a control group (standard NST care). Maternal state anxiety (State-Trait Anxiety Inventory-State), perceived stress and anxiety (DASS-21), blood pressure, heart rate, respiratory rate, oxygen saturation, and NST reactivity were assessed before and after the procedure. The primary objective is to determine whether ney music reduces acute maternal state anxiety during NST. Secondary objectives include evaluating its effects on autonomic physiological parameters and fetal NST reactivity.
- Conditions
- Maternal Anxiety, Stress
- Being tested
- Ney Music
- Keywords
- non-stress test, music intervention, maternal anxiety, autonomic regulation, fetal reactivity, ney music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ney MusicBehavioural
Listening to prerecorded ney music through headphones during the 20-minute NST procedure.
| Study group | Role | What they receive |
|---|---|---|
| Ney Music During NST | Experimental | Pregnant women listened to ney music ("Aşkın Yolculuğu") via headphones for 20 minutes during routine non-stress testing (NST). Receives: Behavioral: Ney Music |
| Standard NST (No Music) | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety (STAI-S Score)
Change in maternal state anxiety measured using the State-Trait Anxiety Inventory-State (STAI-S) before and immediately after the non-stress test (NST).
Measured: Immediately before NST and immediately after NST (20 minutes)
Secondary outcomes (6)
Systolic Blood Pressure (mmHg)
Measured: Before and immediately after NST (20 minutes)
Diastolic Blood Pressure (mmHg)
Measured: Before and immediately after NST (20 minutes)
Heart Rate (beats per minute)
Measured: Before and immediately after NST (20 minutes)
Respiratory Rate (breaths per minute)
Measured: Before and immediately after NST (20 minutes)
Oxygen Saturation (%)
Measured: Before and immediately after NST (20 minutes)
NST Reactivity (Reactive vs Non-reactive)
Measured: During 20-minute NST session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 May 2024
- Primary completion30 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnxietyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hediye Karakoç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hediye Karakoç, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452861
- Sponsor's protocol ID
- 2023/016
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ney Music During the Non-Stress Test on Maternal State Anxiety, Autonomic Regulation, and Fetal Reactivity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07452861
- Acronym / sponsor ID
- 2023/016
- Conditions
- Maternal Anxiety, Stress
- Keywords
- non-stress test, music intervention, maternal anxiety, autonomic regulation, fetal reactivity, ney music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hediye KarakoçUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Mar 2026 (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 randomized controlled trial evaluates the effects of listening to ney music during routine non-stress testing (NST) on maternal psychological and physiological responses and fetal reactivity. Maternal anxiety during NST may activate sympathetic pathways and potentially influence fetal heart rate patterns. A total of 126 pregnant women at ≥32 weeks' gestation were randomly assigned to either an intervention group (ney music during NST) or a control group (standard NST care). Maternal state anxiety (State-Trait Anxiety Inventory-State), perceived stress and anxiety (DASS-21), blood pressure, heart rate, respiratory rate, oxygen saturation, and NST reactivity were assessed before and after the procedure. The primary objective is to determine whether ney music reduces acute maternal state anxiety during NST. Secondary objectives include evaluating its effects on autonomic physiological parameters and fetal NST reactivity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ney Music During NST | Experimental | Behavioral: Ney MusicPregnant women listened to ney music ("Aşkın Yolculuğu") via headphones for 20 minutes during routine non-stress testing (NST). |
| Standard NST (No Music) | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age ≥18 years,
- gestational age ≥32 weeks,
- singleton pregnancy,
- absence of known fetal cardiovascular anomalies,
- no visual or hearing impairments,
Key exclusion criteria (5 listed)
- pre-existing maternal medical conditions (hypertension, diabetes, obesity),
- multiple pregnancy,
- smoking,
- known fetal abnormalities or fetal distress,
- inherited anemia or sexually transmitted infections.
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 |
|---|---|---|
| Ney MusicListening to prerecorded ney music through headphones during the 20-minute NST procedure. | Behavioural | Ney Music During NST |
Primary outcome
State Anxiety (STAI-S Score)
Time frame: Immediately before NST and immediately after NST (20 minutes)
Change in maternal state anxiety measured using the State-Trait Anxiety Inventory-State (STAI-S) before and immediately after the non-stress test (NST).
6 secondary outcomes
Systolic Blood Pressure (mmHg)
Time frame: Before and immediately after NST (20 minutes)
Diastolic Blood Pressure (mmHg)
Time frame: Before and immediately after NST (20 minutes)
Heart Rate (beats per minute)
Time frame: Before and immediately after NST (20 minutes)
Respiratory Rate (breaths per minute)
Time frame: Before and immediately after NST (20 minutes)
Oxygen Saturation (%)
Time frame: Before and immediately after NST (20 minutes)
NST Reactivity (Reactive vs Non-reactive)
Time frame: During 20-minute NST session
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 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ney Music in people with Maternal Anxiety and Stress, run by Hediye Karakoç 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 8 inclusion and 5 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 9 Mar 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?
State Anxiety (STAI-S Score) (time frame: Immediately before NST and immediately after NST (20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.