Delivery FearNCT06271889
The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery
A study testing Non-stress test in people with Delivery Fear and Labor Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped… 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
- Delivery Fear, Labor Pain, Maternal-Fetal Relations
- What is being tested?
- Non-stress test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2021to 24 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
- Who are december the age range of 18- 35,
- The least literate,
- Which is the primiparous,
- who is at the 38-42 week of gestation
- With a single pregnancy in the vertex position,
- Who does not have a systemic disease that will interfere with normal delivery (gestational diabetes, preeclampsia, etc.),
- Who is in the active phase of labor * Pregnant women who have agreed to participate in the study and received informed consent will be included in the study
Who cannot join
- 37. week 42. not between the weeks dec
- It is a multipart,
- Anyone who has any problems with communication,
- Who has ceased to be involved in the study,
- An unexpected complication develops (cesarean section of the pregnant woman, development of fetal distress in the fetus, etc.).
- Oxytocin induction is applied Pregnant women who have been given pain medication (Aldolan, diazem) are
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum
University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women.
Read the detailed description
Application of the Research: Informed voluntary consents will be obtained in written and oral form by giving the necessary information about the study to pregnant women before the application. The form will be signed ". Environmental stimuli before the procedure (noise, heat, light, touch, etc.) will be brought under control. Pregnant women admitted to the maternity hospital will be assigned to the intervention and control group using computer-aided randomization. Routine maintenance will be applied to both groups in the study. Anamnesis and blood are routinely taken from pregnant women admitted to the maternity unit within the scope of routine care in the institution where the research was conducted, and NST is connected by inserting an intravenous catheter. STAI and VAS will be filled in before the application to both groups of pregnant women. after application, the forms will be applied again at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm). In both groups; pulse, respiration and oxygen saturation will be evaluated with body temperature at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm) before and after the application. With decemberibel meter, the frequency range will be kept within the range of 30 dB-90 dB. Participants will be able to adjust the volume of their baby's voice at their own level. No noninvasive and invasive interventions will be applied to pregnant women in the intervention group during the application. If the control group is pregnant, only routine care will be performed. Both groups of pregnant women will be completed with STAI, VAS and the Postpartum Attachment scale before and after the application. The researcher should constantly monitor and evaluate the mother and fetus during the application process, and when discomfort develops, the procedure will be terminated and the clinical specialist physician will be informed.
- Conditions
- Delivery Fear, Labor Pain, Maternal-Fetal Relations
- Being tested
- Non-stress test
- Keywords
- Fetal sound, Labor anxiety, Labor pain, Non Stress Test, Postpartum bonding
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-stress testDevice
It will be performed with the HUNTLEIGH brand BD4000XS-2 model NST device located at the maternity clinic to listen to the fetal heart sound, approximately min 3 max 5 min will be listened to. According to the studies conducted in the literature, the half-life of adrenaline in plasma is 3 minutes when an invasive/noninvasive intervention is performed on an adult individual. Therefore, the fetal heart rate will be listened to for 3 minutes (Dalal \& Grujic; 2021; https://www.medicines.org.uk/emc/product/6284/smpc#gref https://www.ncbi.nlm.nih.gov/books/NBK482160 / )
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group pregnant women will be selected using randomization. their babies' fetal voice will not be listened. |
| Intervention | Active comparator | Pregnant women in the intervention group will be selected using randomization. the fetal voice of their babies will be listened to for about 3-5 minutes with a Non-stress Tester. Receives: Device: Non-stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
VİSUAL ANALOG SCALE
Visual analog scale: The scoring system is between 0 and 10. 0 is considered as no pain, while 10 is considered as unbearable pain.
Measured: immediately Before application
STATUS AND CONTINUOUS ANXIETY SCALE
The state anxiety scale consists of 20 statements. The state anxiety scale requires the individual to answer the feelings or behaviors experienced in the current situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely according to the degree of severity.
Measured: immediately Before application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start24 Nov 2021
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Delivery FearStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Randomized parallel controlled experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
- Investigators
- Rojda BAYAR, PhD.Std., Study chair, Umraniye Education and Research HospitalEbru SAGIROGLU, PhD.Std., Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271889
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/330
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Teijon M, Garcia-Faura A, Prats-Galino A. Fetal facial expression in response to intravaginal music emission. Ultrasound. 2015 Nov;23(4):216-223. doi: 10.1177/1742271X15609367.
PubMed 26539240Jelicic L, Jankovic S, Sovilj M, Adamovic T, Bogavac I, Gavrilovic A, Subotic M. Fetal Middle Cerebral Artery Pulsatility Index in No-Risk Pregnancies: Effects of Auditory Stimulation and Pregnancy Order. Int J Mol Sci. 2020 May 29;21(11):3855. doi: 10.3390/ijms21113855.
PubMed 32485789Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.
PubMed 29144545Wulff V, Hepp P, Fehm T, Schaal NK. Music in Obstetrics: An Intervention Option to Reduce Tension, Pain and Stress. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):967-975. doi: 10.1055/s-0043-118414. Epub 2017 Sep 25.
PubMed 28959060Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.
PubMed 28750631Mahboubeh V, Masoumeh P, Zahra S. Comparison of vibro-acoustic stimulation and acupressure effects in nonstress test results and its parameters in pregnant women. Iran J Nurs Midwifery Res. 2013 Jul;18(4):266-71.
PubMed 24403920
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum
- ClinicalTrials.gov ID
- NCT06271889
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/330
- Conditions
- Delivery Fear, Labor Pain, Maternal-Fetal Relations
- Keywords
- Fetal sound, Labor anxiety, Labor pain, Non Stress Test, Postpartum bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 22 Feb 2024 (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.
University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women.
Detailed description
Application of the Research: Informed voluntary consents will be obtained in written and oral form by giving the necessary information about the study to pregnant women before the application. The form will be signed ". Environmental stimuli before the procedure (noise, heat, light, touch, etc.) will be brought under control. Pregnant women admitted to the maternity hospital will be assigned to the intervention and control group using computer-aided randomization. Routine maintenance will be applied to both groups in the study. Anamnesis and blood are routinely taken from pregnant women admitted to the maternity unit within the scope of routine care in the institution where the research was conducted, and NST is connected by inserting an intravenous catheter. STAI and VAS will be filled in before the application to both groups of pregnant women. after application, the forms will be applied again at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm). In both groups; pulse, respiration and oxygen saturation will be evaluated with body temperature at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm) before and after the application. With decemberibel meter, the frequency range will be kept within the range of 30 dB-90 dB. Participants will be able to adjust the volume of their baby's voice at their own level. No noninvasive and invasive interventions will be applied to pregnant women in the intervention group during the application. If the control group is pregnant, only routine care will be performed. Both groups of pregnant women will be completed with STAI, VAS and the Postpartum Attachment scale before and after the application. The researcher should constantly monitor and evaluate the mother and fetus during the application process, and when discomfort develops, the procedure will be terminated and the clinical specialist physician will be informed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized parallel controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group pregnant women will be selected using randomization. their babies' fetal voice will not be listened. |
| Intervention | Active comparator | Device: Non-stress testPregnant women in the intervention group will be selected using randomization. the fetal voice of their babies will be listened to for about 3-5 minutes with a Non-stress Tester. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Who are december the age range of 18- 35,
- The least literate,
- Which is the primiparous,
- who is at the 38-42 week of gestation
- With a single pregnancy in the vertex position,
Key exclusion criteria (6 listed)
- 37. week 42. not between the weeks dec
- It is a multipart,
- Anyone who has any problems with communication,
- Who has ceased to be involved in the study,
- An unexpected complication develops (cesarean section of the pregnant woman, development of fetal distress in the fetus, etc.).
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 |
|---|---|---|
| Non-stress testIt will be performed with the HUNTLEIGH brand BD4000XS-2 model NST device located at the maternity clinic to listen to the fetal heart sound, approximately min 3 max 5 min will be listened to. According to the studies conducted in the literature, the half-life of adrenaline in plasma is 3 minutes when an invasive/noninvasive intervention is performed on an adult individual. Therefore, the fetal heart rate will be listened to for 3 minutes (Dalal \& Grujic; 2021; https://www.medicines.org.uk/emc/product/6284/smpc#gref https://www.ncbi.nlm.nih.gov/books/NBK482160 / ) | Device | Intervention |
Primary outcome
VİSUAL ANALOG SCALE
Time frame: immediately Before application
Visual analog scale: The scoring system is between 0 and 10. 0 is considered as no pain, while 10 is considered as unbearable pain.
STATUS AND CONTINUOUS ANXIETY SCALE
Time frame: immediately Before application
The state anxiety scale consists of 20 statements. The state anxiety scale requires the individual to answer the feelings or behaviors experienced in the current situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely according to the degree of severity.
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 12 Jan 2026.
- Results publication: PubMed 26539240Lopez-Teijon M, Garcia-Faura A, Prats-Galino A. Fetal facial expression in response to intravaginal music emission. Ultrasound. 2015 Nov;23(4):216-223. doi: 10.1177/1742271X15609367.
- Results publication: PubMed 32485789Jelicic L, Jankovic S, Sovilj M, Adamovic T, Bogavac I, Gavrilovic A, Subotic M. Fetal Middle Cerebral Artery Pulsatility Index in No-Risk Pregnancies: Effects of Auditory Stimulation and Pregnancy Order. Int J Mol Sci. 2020 May 29;21(11):3855. doi: 10.3390/ijms21113855.
- Results publication: PubMed 29144545Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.
- Results publication: PubMed 28959060Wulff V, Hepp P, Fehm T, Schaal NK. Music in Obstetrics: An Intervention Option to Reduce Tension, Pain and Stress. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):967-975. doi: 10.1055/s-0043-118414. Epub 2017 Sep 25.
- Results publication: PubMed 28750631Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.
- Results publication: PubMed 24403920Mahboubeh V, Masoumeh P, Zahra S. Comparison of vibro-acoustic stimulation and acupressure effects in nonstress test results and its parameters in pregnant women. Iran J Nurs Midwifery Res. 2013 Jul;18(4):266-71.
- 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.
Rojda BAYAR, PhD.Std. study chair
Umraniye Education and Research Hospital
Ebru SAGIROGLU, PhD.Std. principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-stress test in people with Delivery Fear and Labor Pain, run by Saglik Bilimleri Universitesi 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 7 inclusion and 6 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 12 Jan 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?
VİSUAL ANALOG SCALE (time frame: immediately Before application). The study lists 2 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 NCT06271889, which also lists 6 linked publications.
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 12 Jan 2026.