Pregnant WomenNCT07299214
Music During Non-Stress Testing
A study testing Music intervention in people with Pregnant Women, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Aug 2025
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-45 years
- Completion of at least the 32nd week of gestation
- No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
- No multiple pregnancy
- Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
- Having eaten at least two hours before the NST procedure
Show all 10Show fewer
- No smoking or alcohol consumption for at least two hours before the NST procedure
- Ability to communicate effectively
- No hearing impairment
- Voluntary participation in the study
Who cannot join
- Pregnant women with fetal distress
- Cases for whom the physician considered emergency intervention necessary
- Individuals with an impaired NST requiring immediate intervention
- Individuals with a diagnosed psychiatric disorder
- Individuals with hearing impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University District, 2076 Street, No: 11
Karaman, Central, 70200
About this study
Official title: The Effect of Music During Non-Stress Testing on Women's Comfort, Vital Signs and Anxiety: A Randomized Controlled Study
Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.
- Conditions
- Pregnant Women
- Being tested
- Music intervention
- Keywords
- non-stress test, music, comfort, vital signs, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | After the pregnant women were positioned, while the NST procedure was implemented they listened to music for 20-30 minutes. The pregnant women listened to the music on an MP3 player during the application. The duration of the music recorded on the MP3 player was 30 minutes. The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect Receives: Other: Music intervention |
| Control Group | No intervention | Pregnant women were not subjected to any intervention during the NST procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
During Non-Stress Testing on Women's Comfort Level
Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is.
Measured: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Systolic Blood Pressure Level
The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
Measured: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Diastolic Blood Pressure Level
The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
Measured: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Heart Rate Level
Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm).
Measured: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
During Non-Stress Testing on Women's Anxiety Level
State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).
Measured: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jun 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Pregnant women meeting the study criteria were randomly assigned to the experimental and control groups using a simple randomization method via the Research Randomizer website application (https://www.randomizer.org/).
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAMZE GOKE ARSLAN, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299214
- Sponsor's protocol ID
- KMBU-NST-2025-01
- Other IDs
- 2169 (Ethics decision number)
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music During Non-Stress Testing on Women's Comfort, Vital Signs and Anxiety: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07299214
- Acronym / sponsor ID
- KMBU-NST-2025-01
- Conditions
- Pregnant Women
- Keywords
- non-stress test, music, comfort, vital signs, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 23 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.
Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women meeting the study criteria were randomly assigned to the experimental and control groups using a simple randomization method via the Research Randomizer website application (https://www.randomizer.org/).
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: Music interventionAfter the pregnant women were positioned, while the NST procedure was implemented they listened to music for 20-30 minutes. The pregnant women listened to the music on an MP3 player during the application. The duration of the music recorded on the MP3 player was 30 minutes. The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect |
| Control Group | No intervention | –Pregnant women were not subjected to any intervention during the NST procedure. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women aged 18-45 years
- Completion of at least the 32nd week of gestation
- No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
- No multiple pregnancy
- Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
Key exclusion criteria (5 listed)
- Pregnant women with fetal distress
- Cases for whom the physician considered emergency intervention necessary
- Individuals with an impaired NST requiring immediate intervention
- Individuals with a diagnosed psychiatric disorder
- Individuals with hearing impairment
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 |
|---|---|---|
| Music interventionThe music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect. | Other | Music Group |
Primary outcome
During Non-Stress Testing on Women's Comfort Level
Time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is.
During Non-Stress Testing on Women's Systolic Blood Pressure Level
Time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
During Non-Stress Testing on Women's Diastolic Blood Pressure Level
Time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg).
During Non-Stress Testing on Women's Heart Rate Level
Time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm).
During Non-Stress Testing on Women's Anxiety Level
Time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Music intervention in people with Pregnant Women, run by Karamanoğlu Mehmetbey 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 10 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 19 Oct 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?
During Non-Stress Testing on Women's Comfort Level (time frame: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)). The study lists 5 primary outcomes in all. 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 19 Oct 2026.