Fetal HealthNCT05325840
Non Stress Test and Music Performance
A study testing music terapy in people with Fetal Health and Pregnancy Related, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Health, Pregnancy Related
- What is being tested?
- music terapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2022to 29 Aug 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Become literate
- Be in the 18-45 age range.
- Being at the 32nd and above gestational week
- Not carrying any risk factors during pregnancy (preeclampsia, IUGR, gestational diabetes, etc.)
- Have eaten at least two hours before the NST procedure
- No fetal defined cardiovascular disease
- The pregnant woman is open to communication and does not have mental or mental problems.
- Absence of auditory problems
Who cannot join
- Absence of illiteracy of the pregnant woman
- Uterine contraction in NST
- Pregnant women who need fetal distress and urgent intervention by the physician
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bingöl Solhan Devlet Hastanesi
Bingoel, Solhan Bingöl
About this study
Official title: Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. NST is a procedure in which fetal heart sounds are recorded and the relationship between fetal movements and fetal heart beat is monitored.3 Various methods are used to minimize the psychological effects that occur during pregnancy. Among these methods, it has been seen in the studies in the literature that music, which is a non-pharmacological method, has a positive effect on the pregnant woman and the fetus. It is easy and enjoyable to listen to music during the routine non-stress test process. However, there are not enough studies to prove the effect of music.
The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.
Read the detailed description
expected
- Conditions
- Fetal Health, Pregnancy Related
- Being tested
- music terapy
- Keywords
- music, pregnancy, nonstrest test, fetal, health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music terapyOther
The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| music therapy | Experimental | Experimental Group: Pre-test will be applied to pregnant women before the intervention. Since ST will be applied later, Nki will be applied to pregnant women, and their props will then be right lateral or lateral. NST registration form will be filled.
After the pregnancy is given, the type of music (Classical Turkish Music, Turkish Classical Music, Lullaby) is asked according to the preferences of the pregnant women and their music is given for 20 minutes. The NST process will be implemented from start to finish. In the application, music from pregnant women will be played on MP3 players. After the NST procedure is applied, the pregnant women will have a son. Receives: Other: music terapy |
| standard of care | No intervention | Control group: First of all, Personal Information Form, State Anxiety Scale and blood pressure measurement will be made to the pregnant women in the control group. In order to perform the NST procedure, the pregnant women will be given the left side or right side position to fix the probes. NST registration form will be filled. 20 minutes after positioning the pregnant women. During the routine NST procedure will be applied and no intervention will be made. After the NST procedure is completed, the State Anxiety Scale and blood pressure measurement will be repeated as the last test of the pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
The research is an experimentally planned randomized controlled trial.The sample of the study consists of pregnant women (69 experimental group, 68 control group) between 32nd and 41st weeks. The pregnant women were evaluated with the state anxiety scale. The scale consists of 20 items in total. Scoring is calculated by subtracting the total weighted score for the reverse statements from the total weighted score for the direct statements. A predetermined invariant value is added to this obtained number.This value is 50 for the state anxiety scale. The most recent value is the individual's anxiety score. As the score obtained from the scale increases, it indicates that the level of anxiety increases. 0-19 point no anxiety, 20-39 points mild anxiety, 40-59 points moderate anxiety, 60-79 points severe anxiety, 80 points severe anxiety.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 Nov 2022
- Primary completion4 Apr 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HealthStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel ÖZTÜRK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325840
- Sponsor's protocol ID
- Ataturk University SÖZTÜRK0002
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
- ClinicalTrials.gov ID
- NCT05325840
- Acronym / sponsor ID
- Ataturk University SÖZTÜRK0002
- Conditions
- Fetal Health, Pregnancy Related
- Keywords
- music, pregnancy, nonstrest test, fetal, health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 13 Apr 2022 (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.
Today, many methods are used in the evaluation of intrauterine fetal well-being. Non-stress test (NST) method is mostly used in the non-invasive evaluation of fetal well-being during pregnancy and labor. NST is a procedure in which fetal heart sounds are recorded and the relationship between fetal movements and fetal heart beat is monitored.3 Various methods are used to minimize the psychological effects that occur during pregnancy. Among these methods, it has been seen in the studies in the literature that music, which is a non-pharmacological method, has a positive effect on the pregnant woman and the fetus. It is easy and enjoyable to listen to music during the routine non-stress test process. However, there are not enough studies to prove the effect of music.
The aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure.
Detailed description
expected
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music therapy | Experimental | Other: music terapyExperimental Group: Pre-test will be applied to pregnant women before the intervention. Since ST will be applied later, Nki will be applied to pregnant women, and their props will then be right lateral or lateral. NST registration form will be filled. After the pregnancy is given, the type of music (Classical Turkish Music, Turkish Classical Music, Lullaby) is asked according to the preferences of the pregnant women and their music is given for 20 minutes. The NST process will be implemented from start to finish. In the application, music from pregnant women will be played on MP3 players. After the NST procedure is applied, the pregnant women will have a son. |
| standard of care | No intervention | –Control group: First of all, Personal Information Form, State Anxiety Scale and blood pressure measurement will be made to the pregnant women in the control group. In order to perform the NST procedure, the pregnant women will be given the left side or right side position to fix the probes. NST registration form will be filled. 20 minutes after positioning the pregnant women. During the routine NST procedure will be applied and no intervention will be made. After the NST procedure is completed, the State Anxiety Scale and blood pressure measurement will be repeated as the last test of the pregnant women. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Become literate
- Be in the 18-45 age range.
- Being at the 32nd and above gestational week
- Not carrying any risk factors during pregnancy (preeclampsia, IUGR, gestational diabetes, etc.)
- Have eaten at least two hours before the NST procedure
Key exclusion criteria (3 listed)
- Absence of illiteracy of the pregnant woman
- Uterine contraction in NST
- Pregnant women who need fetal distress and urgent intervention by the physician
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 terapyThe aim of this study was to examine the effects of the music concert applied during the nonstress test procedure on the health of the fetus, the anxiety level of the pregnant woman and blood pressure. | Other | music therapy |
Primary outcome
Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure
Time frame: Day 1
The research is an experimentally planned randomized controlled trial.The sample of the study consists of pregnant women (69 experimental group, 68 control group) between 32nd and 41st weeks. The pregnant women were evaluated with the state anxiety scale. The scale consists of 20 items in total. Scoring is calculated by subtracting the total weighted score for the reverse statements from the total weighted score for the direct statements. A predetermined invariant value is added to this obtained number.This value is 50 for the state anxiety scale. The most recent value is the individual's anxiety score. As the score obtained from the scale increases, it indicates that the level of anxiety increases. 0-19 point no anxiety, 20-39 points mild anxiety, 40-59 points moderate anxiety, 60-79 points severe anxiety, 80 points severe anxiety.
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 11 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Fetal Health
Recruiting
The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
Fetal Health Anxiety, Prenatal Distress
Recruiting
Virtual Reality-Based and Face-to-Face Relaxation Programs in Pregnant Women With Preeclampsia
Pre-Eclampsia, Maternal Health
Not yet recruiting
Artificial Intelligence Education and Climate Awareness in Pregnancy
Climate Change, Maternal Health
Recruiting
Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly
Fetal Diseases, Congenital Abnormalities
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 terapy in people with Fetal Health and Pregnancy Related, run by Ataturk 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 8 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 11 Sep 2023. 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?
Evaluation of the Effect of Music Played During the Non-Stress Test on Fetal Health, Anxiety Level of the Pregnant and Blood Pressure (time frame: Day 1). 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 11 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.