36-40 haftalık HamileNCT06792357
Vagus Nerve Stimulation and Labor
A study testing Vagal Active Tone Application Procedure in people with 36-40 haftalık Hamile, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The vagus nerve innervates both the uterus and the cervix. It is thought that a successful and positive birth experience can be achieved by stimulating the vagus nerve at the desired level. Making instinctive sounds such as singing, humming, and various exercises are methods that stimulate the vagus nerve. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 36-40 haftalık Hamile
- What is being tested?
- Vagal Active Tone Application Procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who volunteer to participate in the study, are primiparous and in the 28-32nd week of pregnancy, Normal vaginal birth, Single fetus and cephalic presentation, 19 years of age or older, Communicate in Turkish will be included in the study.
Who cannot join
- Women with obstetric complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, polyhydramnios, presentation disorder, intrauterine growth retardation, İntrauterine dead fetus, macrosomic baby, fetal distress, etc.), Have a psychiatric diagnosis, Have a systemic disease, Have a heart and brain pacemaker, Have epilepsy, Have vision and hearing problems, Attend a childbirth preparation class, Undergo medical procedures for any reason at birth will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Cukurova Unıversıty
Adana, Cukurova, 0001
rkysulu@gmail.com
About this study
Official title: Effects of Vagus Nerve Stimulation Based on Polyvagal Theory on Labor Pain, Anxiety, Oxytocin, Cortisol Levels, Labor Duration and Perception
The vagus nerve innervates both the uterus and the cervix. It is thought that a successful and positive birth experience can be achieved by stimulating the vagus nerve at the desired level. Making instinctive sounds such as singing, humming, and various exercises are methods that stimulate the vagus nerve. In this project, an application protocol based on polyvagal theory and including breathing, relaxation and voice exercises was prepared. Video-supported application material will be developed in line with the prepared protocol. The video-assisted vagus nerve stimulation intervention is called Vagal Active Tone (VAT). VAT is a new method in the literature and for which we have limited information about labor. This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. This study was planned as a randomized controlled experimental study. The number of samples was calculated using the G*power 3.1.9.6 program. After the power analysis, it is aimed to reach a total of 50 people, 25 in the intervention group and 25 in the control group. Data will be collected with Personal Information Form, Labor Monitoring Form, Hormone Levels Monitoring Form, Visual Analogue Scale, State Anxiety Scale, Facial Anxiety Scale and Mother's Birth Perception Scale.
It is aimed to produce new and original evidence-based information with the use of VAT intervention based on polyvagal theory. It is thought that this intervention, which can be easily accessed and applied by pregnant women whenever they want, will contribute positively to labor pain, anxiety, oxytocin and cortisol levels, and the duration and perception of birth.
Keywords: Labor, oxytocin, cortisol, vagus nerve stimulation, midwife
- Conditions
- 36-40 haftalık Hamile
- Being tested
- Vagal Active Tone Application Procedure
- Keywords
- Emek, oksitozin, kortizol, vagus sinir stimülasyonu, Ebe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal Active Tone Application ProcedureOther
First section; A video will be created that includes pictures and visuals describing the vagus nerve, explaining its benefits, and providing information about its effects and usage during the birth process.
Second section; Deep breathing and focus exercises;
Feather Breath:
Candle Breath: The pregnant woman inhaled and exhaled as if she was trying to blow out a candle.
Relaxation Breath: Deep breath Third section; Body relaxation exercises; Fourth section; Facial muscle relaxation exercises; Fifth section; Neck and larynx muscle relaxation exercises;
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Vagus nerve stimulation based on polyvagal theory and routine application Receives: Other: Vagal Active Tone Application Procedure |
| Control Group | No intervention | Routine maintenance; Routine care and treatment of women will continue during data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Visual Analog Scale (VAS): VAS is a one-dimensional scale that objectively evaluates the pain perception of the pregnant woman. It allows some values that cannot be measured numerically to be converted into numerical form. VAS was developed and used by Bond and Pilowsky in 1966. VAS is a 10 cm ruler scale used to quantitatively determine the intensity of pain, with one end representing painlessness (0 = no pain) and the other end representing the most severe pain (10 = severe pain). The patient marks any place between two points that matches the intensity of the pain. The distance between the end of the scale representing painlessness and the point marked by the patient is measured with a ruler and recorded in cm. This numerical value obtained shows the intensity of the pregnant woman's pain.
Measured: 30 minutes later (post intervention)
Facial Anxiety Scale (FAS)
Facial Anxiety Scale (FAS): It is a one-dimensional, individual-based anxiety assessment tool. Its Turkish validity and reliability study was conducted on patients receiving mechanical ventilation in intensive care. Using this numerical rating scale, researchers determined the image corresponding to the patient's facial expression by ranking the face using a number from 0 to 10. A higher score indicates a higher level of anxiety .
Measured: 30 minutes later (post intervention)
State Anxiety Inventory (SAI)
State Anxiety Inventory (SAI): The scale (5) developed by Spielberg and colleagues (1964) to measure the state anxiety levels of normal and abnormal individuals was adapted to Turkish by Öner and Le Compte (1983). The state anxiety inventory was developed to measure a person's anxiety at a certain moment. The 20-item state anxiety inventory is a scale that determines how an individual feels at a certain moment and under a certain condition. SAI is a 4-point Likert-type scale. There are 10 reversed statements on the scale. These statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of direct and reverse statements. The scores obtained in the state anxiety scale theoretically vary between 20 and 80 points. The Cronbach Alpha internal consistency rate of SAI was found to be 0.96.
Measured: 30 minutes later (post intervention)
Maternal Birth Perception Scale (MBS)
Maternal Birth Perception Scale (MBS): It is a tool that assesses how mothers perceive their experiences during normal or unplanned cesarean births. MBS is a 25-item, 5-subscale, and 5-point Likert-type scale developed by Fawcett and Knauth (1997) (7). The sub-dimensions of the scale are experiences during birth (7 items; 3, 5, 6, 8, 15, 17, 18), experiences during the painful period of birth (7 items; 1, 2, 4, 7, 9, 10, 16), postpartum (4 items; 22, 23, 24, 25), spouse participation (4 items; 11,12,20,21), and awareness (3 items; 13,14,19). Since the questions numbered 15-16-17-18-19 of the scale contain negative expressions, the scoring is done in reverse direction in these questions. The translation of ADAÖ into Turkish and the validity and reliability study were carried out by Güngör and Beji (2007). ADAÖ, Cronbach Alpha internal consistency rate was found to be 0.83 (8). Permission for use of the scale was obtained (Appendix-8).
Measured: 30 minutes later (post intervention)
Hormone Values Monitoring Form
Hormone Values Monitoring Form: This is the form in which the oxytocin and cortisol results of the pregnant women participating in the study are monitored.
Measured: 30 minutes later (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 36-40 haftalık HamileStudies 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 project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. In this regard, the planned targets are; * It is to determine the effect of vagus nerve stimulation on labor pain in pregnant women, based on Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the anxiety level of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the oxytocin level of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on cortisol levels of pregnant women, based on Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the duration of birth of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the birth perception of pregnant women, based on Polyvagal theory.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Sülü Dursun, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792357
- Sponsor's protocol ID
- CukurovaUnv
- Other IDs
- Project NO: 124S403
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2024
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Stimulation Based on Polyvagal Theory on Labor Pain, Anxiety, Oxytocin, Cortisol Levels, Labor Duration and Perception
- ClinicalTrials.gov ID
- NCT06792357
- Acronym / sponsor ID
- CukurovaUnv
- Conditions
- 36-40 haftalık Hamile
- Keywords
- Emek, oksitozin, kortizol, vagus sinir stimülasyonu, Ebe
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 24 Jan 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.
The vagus nerve innervates both the uterus and the cervix. It is thought that a successful and positive birth experience can be achieved by stimulating the vagus nerve at the desired level. Making instinctive sounds such as singing, humming, and various exercises are methods that stimulate the vagus nerve. In this project, an application protocol based on polyvagal theory and including breathing, relaxation and voice exercises was prepared. Video-supported application material will be developed in line with the prepared protocol. The video-assisted vagus nerve stimulation intervention is called Vagal Active Tone (VAT). VAT is a new method in the literature and for which we have limited information about labor. This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. This study was planned as a randomized controlled experimental study. The number of samples was calculated using the G*power 3.1.9.6 program. After the power analysis, it is aimed to reach a total of 50 people, 25 in the intervention group and 25 in the control group. Data will be collected with Personal Information Form, Labor Monitoring Form, Hormone Levels Monitoring Form, Visual Analogue Scale, State Anxiety Scale, Facial Anxiety Scale and Mother's Birth Perception Scale.
It is aimed to produce new and original evidence-based information with the use of VAT intervention based on polyvagal theory. It is thought that this intervention, which can be easily accessed and applied by pregnant women whenever they want, will contribute positively to labor pain, anxiety, oxytocin and cortisol levels, and the duration and perception of birth.
Keywords: Labor, oxytocin, cortisol, vagus nerve stimulation, midwife
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This project aimed to determine the effect of vagus nerve stimulation based on Polyvagal theory on labor pain, anxiety, oxytocin, cortisol levels, duration and perception of birth. In this regard, the planned targets are; * It is to determine the effect of vagus nerve stimulation on labor pain in pregnant women, based on Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the anxiety level of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the oxytocin level of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on cortisol levels of pregnant women, based on Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the duration of birth of pregnant women, based on the Polyvagal theory. * It is to determine the effect of vagus nerve stimulation on the birth perception of pregnant women, based on Polyvagal theory.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Vagal Active Tone Application ProcedureVagus nerve stimulation based on polyvagal theory and routine application |
| Control Group | No intervention | –Routine maintenance; Routine care and treatment of women will continue during data collection. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who volunteer to participate in the study, are primiparous and in the 28-32nd week of pregnancy, Normal vaginal birth, Single fetus and cephalic presentation, 19 years of age or older, Communicate in Turkish will be included in the study.
Key exclusion criteria (1 listed)
- Women with obstetric complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios, polyhydramnios, presentation disorder, intrauterine growth retardation, İntrauterine dead fetus, macrosomic baby, fetal distress, etc.), Have a psychiatric diagnosis, Have a systemic disease, Have a heart and brain pacemaker, Have epilepsy, Have vision and hearing problems, Attend a childbirth preparation class, Undergo medical procedures for any reason at birth will be excluded from the study.
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 |
|---|---|---|
| Vagal Active Tone Application ProcedureFirst section; A video will be created that includes pictures and visuals describing the vagus nerve, explaining its benefits, and providing information about its effects and usage during the birth process. Second section; Deep breathing and focus exercises; Feather Breath: Candle Breath: The pregnant woman inhaled and exhaled as if she was trying to blow out a candle. Relaxation Breath: Deep breath Third section; Body relaxation exercises; Fourth section; Facial muscle relaxation exercises; Fifth section; Neck and larynx muscle relaxation exercises; | Other | Intervention Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 30 minutes later (post intervention)
Visual Analog Scale (VAS): VAS is a one-dimensional scale that objectively evaluates the pain perception of the pregnant woman. It allows some values that cannot be measured numerically to be converted into numerical form. VAS was developed and used by Bond and Pilowsky in 1966. VAS is a 10 cm ruler scale used to quantitatively determine the intensity of pain, with one end representing painlessness (0 = no pain) and the other end representing the most severe pain (10 = severe pain). The patient marks any place between two points that matches the intensity of the pain. The distance between the end of the scale representing painlessness and the point marked by the patient is measured with a ruler and recorded in cm. This numerical value obtained shows the intensity of the pregnant woman's pain.
Facial Anxiety Scale (FAS)
Time frame: 30 minutes later (post intervention)
Facial Anxiety Scale (FAS): It is a one-dimensional, individual-based anxiety assessment tool. Its Turkish validity and reliability study was conducted on patients receiving mechanical ventilation in intensive care. Using this numerical rating scale, researchers determined the image corresponding to the patient's facial expression by ranking the face using a number from 0 to 10. A higher score indicates a higher level of anxiety .
State Anxiety Inventory (SAI)
Time frame: 30 minutes later (post intervention)
State Anxiety Inventory (SAI): The scale (5) developed by Spielberg and colleagues (1964) to measure the state anxiety levels of normal and abnormal individuals was adapted to Turkish by Öner and Le Compte (1983). The state anxiety inventory was developed to measure a person's anxiety at a certain moment. The 20-item state anxiety inventory is a scale that determines how an individual feels at a certain moment and under a certain condition. SAI is a 4-point Likert-type scale. There are 10 reversed statements on the scale. These statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of direct and reverse statements. The scores obtained in the state anxiety scale theoretically vary between 20 and 80 points. The Cronbach Alpha internal consistency rate of SAI was found to be 0.96.
Maternal Birth Perception Scale (MBS)
Time frame: 30 minutes later (post intervention)
Maternal Birth Perception Scale (MBS): It is a tool that assesses how mothers perceive their experiences during normal or unplanned cesarean births. MBS is a 25-item, 5-subscale, and 5-point Likert-type scale developed by Fawcett and Knauth (1997) (7). The sub-dimensions of the scale are experiences during birth (7 items; 3, 5, 6, 8, 15, 17, 18), experiences during the painful period of birth (7 items; 1, 2, 4, 7, 9, 10, 16), postpartum (4 items; 22, 23, 24, 25), spouse participation (4 items; 11,12,20,21), and awareness (3 items; 13,14,19). Since the questions numbered 15-16-17-18-19 of the scale contain negative expressions, the scoring is done in reverse direction in these questions. The translation of ADAÖ into Turkish and the validity and reliability study were carried out by Güngör and Beji (2007). ADAÖ, Cronbach Alpha internal consistency rate was found to be 0.83 (8). Permission for use of the scale was obtained (Appendix-8).
Hormone Values Monitoring Form
Time frame: 30 minutes later (post intervention)
Hormone Values Monitoring Form: This is the form in which the oxytocin and cortisol results of the pregnant women participating in the study are monitored.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Active Tone Application Procedure in people with 36-40 haftalık Hamile, run by Cukurova 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rukiye Sülü Dursun Sülü Dursun, PhD student (+905531826562, rkysulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 30 minutes later (post intervention)). 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 24 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.