Labor Pain and to Reduce PainBREATHNCT07357246
Breathing Exercises Guided by Student Midwives During Labor
A study testing Guided Breathing Exercises During Labor and Routine Intrapartum Care in people with Labor Pain and to Reduce Pain and Childbirth, run by Antalya Bilim University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effect of breathing exercises applied under the guidance of student midwives during labor on labor pain, labor duration, and birth satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain and to Reduce Pain, Childbirth, Normal Labor
- What is being tested?
- Guided Breathing Exercises During Labor and Routine Intrapartum Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 15 Mar 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older
- Term pregnancy (≥37 weeks of gestation)
- Singleton pregnancy
- Planning vaginal birth
- In the active phase of labor
- Able to communicate and provide informed consent
Who cannot join
- High-risk pregnancy (e.g., preeclampsia, placenta previa, severe medical complications)
- Multiple pregnancy
- Planned cesarean section
- Use of pharmacological pain relief at admission (e.g., epidural analgesia)
- Known fetal anomalies
- Inability to participate in breathing exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breathing Exercises Applied Under the Guidance of Student Midwives During Birth on Labor Pain, Labor Duration and Birth Satisfaction: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effect of breathing exercises applied under the guidance of student midwives during labor on labor pain, labor duration, and birth satisfaction. The intervention group received structured breathing exercises guided by student midwives throughout labor, while the control group received routine intrapartum care. Outcomes were assessed during labor and in the early postpartum period
Read the detailed description
This study is designed to evaluate the effect of a midwifery-led intervention on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted as a controlled clinical study in a maternity hospital setting. Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be invited to participate and will provide informed consent prior to enrollment.
The study aims to determine whether the midwifery-led intervention is associated with reduced labor pain intensity and improved birth satisfaction compared to routine care.
- Conditions
- Labor Pain and to Reduce Pain, Childbirth, Normal Labor
- Being tested
- Guided Breathing Exercises During Labor, Routine Intrapartum Care
- Keywords
- Breathing Exercises, Labor Pain, Student Midwives, Birth Satisfaction, Labor Duration, Midwifery Care
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Breathing Exercises During LaborBehavioural
Structured breathing exercises delivered and monitored by student midwives during labor.
Routine Intrapartum CareOther
Standard intrapartum care provided according to hospital protocols.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercises Guided by Student Midwives | Experimental | Participants in this group will receive structured breathing exercises in addition to routine intrapartum care. The breathing exercises will be guided by trained student midwives from admission to the labor ward until birth. The intervention will include slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions, with continuous guidance and encouragement provided according to a standardized protocol. Receives: Behavioral: Guided Breathing Exercises During Labor |
| Routine Intrapartum Care | Active comparator | Participants in this group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital. Routine care includes regular maternal and fetal monitoring, clinical assessment by midwives and obstetric staff, support during labor as per standard practice, and medical or obstetric interventions if clinically indicated. No structured breathing exercise program will be provided. Receives: Other: Routine Intrapartum Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)
Labor pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The outcome will be the VAS score reported by the participant at each assessment time point.
Measured: At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
Secondary outcomes (1)
Birth satisfaction measured by the Birth Satisfaction Scale Revised (BSS-R)
Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised (BSS-R), a 10-item scale with total scores ranging from 0 to 40, where higher scores indicate greater birth satisfaction.
Measured: Within the first 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Sep 2024
- Primary completion3 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Pain and to Reduce PainStudies 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seda Serhatlioglu, Doctorate, Principal investigator, Antalya Bilim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357246
- Sponsor's protocol ID
- 2026-SS
- Other IDs
- 1919B012324751
- Acronym
- BREATH
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercises Applied Under the Guidance of Student Midwives During Birth on Labor Pain, Labor Duration and Birth Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07357246
- Acronym / sponsor ID
- BREATH / 2026-SS
- Conditions
- Labor Pain and to Reduce Pain, Childbirth, Normal Labor
- Keywords
- Breathing Exercises, Labor Pain, Student Midwives, Birth Satisfaction, Labor Duration, Midwifery Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Antalya Bilim UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 21 Jan 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 aimed to evaluate the effect of breathing exercises applied under the guidance of student midwives during labor on labor pain, labor duration, and birth satisfaction. The intervention group received structured breathing exercises guided by student midwives throughout labor, while the control group received routine intrapartum care. Outcomes were assessed during labor and in the early postpartum period
Detailed description
This study is designed to evaluate the effect of a midwifery-led intervention on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted as a controlled clinical study in a maternity hospital setting. Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be invited to participate and will provide informed consent prior to enrollment.
The study aims to determine whether the midwifery-led intervention is associated with reduced labor pain intensity and improved birth satisfaction compared to routine care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises Guided by Student Midwives | Experimental | Behavioral: Guided Breathing Exercises During LaborParticipants in this group will receive structured breathing exercises in addition to routine intrapartum care. The breathing exercises will be guided by trained student midwives from admission to the labor ward until birth. The intervention will include slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions, with continuous guidance and encouragement provided according to a standardized protocol. |
| Routine Intrapartum Care | Active comparator | Other: Routine Intrapartum CareParticipants in this group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital. Routine care includes regular maternal and fetal monitoring, clinical assessment by midwives and obstetric staff, support during labor as per standard practice, and medical or obstetric interventions if clinically indicated. No structured breathing exercise program will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 years and older
- Term pregnancy (≥37 weeks of gestation)
- Singleton pregnancy
- Planning vaginal birth
- In the active phase of labor
Key exclusion criteria (6 listed)
- High-risk pregnancy (e.g., preeclampsia, placenta previa, severe medical complications)
- Multiple pregnancy
- Planned cesarean section
- Use of pharmacological pain relief at admission (e.g., epidural analgesia)
- Known fetal anomalies
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 |
|---|---|---|
| Guided Breathing Exercises During LaborStructured breathing exercises delivered and monitored by student midwives during labor. | Behavioural | Breathing Exercises Guided by Student Midwives |
| Routine Intrapartum CareStandard intrapartum care provided according to hospital protocols. | Other | Routine Intrapartum Care |
Primary outcome
Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10)
Time frame: At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.
Labor pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The outcome will be the VAS score reported by the participant at each assessment time point.
1 secondary outcome
Birth satisfaction measured by the Birth Satisfaction Scale Revised (BSS-R)
Time frame: Within the first 24 hours postpartum
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 4 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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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.
Seda Serhatlioglu, Doctorate principal investigator
Antalya Bilim Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Breathing Exercises During Labor and Routine Intrapartum Care in people with Labor Pain and to Reduce Pain and Childbirth, run by Antalya Bilim 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 6 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 4 Feb 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?
Labor pain intensity measured by the Visual Analog Scale (VAS) (0-10) (time frame: At admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.). 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 4 Feb 2026.