Labor PainRebozo TechniqNCT07759479
Effects of the Rebozo Technique During Active Labor on Labor Pain and Labor Duration in Primiparous Women
A study testing Rebozo technique and Routine Intrapartum care in people with Labor Pain and Labor Duration, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Study Description Childbirth is a physiological process often accompanied by severe pain and prolonged labor, which may negatively affect maternal well-being and increase the likelihood of obstetric interventions. 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
- Labor Pain, Labor Duration, Childbirth
- What is being tested?
- Rebozo technique and Routine Intrapartum care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 30 Jun 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
- Primiparous women
- Aged 18-35 years
- Singleton pregnancy
- Cephalic fetal presentation
- Gestational age between 37 and 42 completed weeks
- Spontaneous onset of labor
Show all 10Show fewer
- Cervical dilatation of 6 cm (active phase of labor)
- No contraindication to vaginal birth
- Able to communicate in Turkish
- Provided written informed consent
Who cannot join
- Multiple pregnancy
- Non-cephalic fetal presentation
- Previous uterine surgery
- Pregnancy complications requiring emergency obstetric intervention
- Planned cesarean birth
- Maternal or fetal conditions requiring immediate delivery
- Refusal or withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, 34408
About this study
Official title: Effects of the Rebozo Technique Applied During the Active Phase of Labor on Labor Pain Intensity and Labor Duration in Primiparous Women: A Parallel-Group Randomized Controlled Trial
Study Description
Childbirth is a physiological process often accompanied by severe pain and prolonged labor, which may negatively affect maternal well-being and increase the likelihood of obstetric interventions. Non-pharmacological approaches that support physiological labor are recommended as part of evidence-based intrapartum care. The Rebozo technique is a traditional midwifery intervention involving rhythmic pelvic mobilization using a woven cloth to promote maternal comfort, facilitate fetal descent and rotation, and improve labor progression.
Read more
This single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of the Rebozo technique on labor pain intensity and labor duration among primiparous women during the active phase of labor. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group, receiving the Rebozo technique in addition to routine intrapartum care, or the control group, receiving routine intrapartum care alone.
The primary outcomes are labor pain intensity, assessed using the Visual Analog Scale (VAS), and labor duration, measured from the active phase of labor (6 cm cervical dilatation) until birth. The findings are expected to provide evidence regarding the effectiveness, feasibility, and clinical applicability of the Rebozo technique as a safe, low-cost, non-pharmacological intervention to support physiological childbirth and improve maternal intrapartum outcomes.
- Conditions
- Labor Pain, Labor Duration, Childbirth, Management of Delivery, Rebozo at Birth
- Being tested
- Rebozo technique, Routine Intrapartum 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.
Rebozo techniqueProcedure or surgery
The Rebozo technique is a standardized non-pharmacological intervention performed using a traditional woven cloth to provide rhythmic pelvic mobilization during the active phase of labor. The intervention was administered in three sessions of approximately five minutes each by a trained researcher in addition to routine intrapartum care.
Routine Intrapartum careOther
Routine intrapartum care was provided according to the institutional clinical protocol and included maternal and fetal monitoring, assessment of labor progress, supportive midwifery care, and obstetric management when clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Rebozo Group | Experimental | Participants allocated to this group received the Rebozo technique in addition to routine intrapartum care. The Rebozo technique was applied during the active phase of labor using a standardized protocol consisting of three sessions of approximately five minutes each. Receives: Procedure: Rebozo technique; Other: Routine Intrapartum care |
| Control Group | Active comparator | Participants allocated to the control group received routine intrapartum care according to the institutional labor management protocol. No Rebozo intervention was administered. 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 Assessed Using the Visual Analog Scale for Pain
Labor pain intensity was assessed using the 10-cm Visual Analog Scale for Pain, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and therefore a worse outcome. Scores were recorded immediately before and immediately after completion of the Rebozo intervention. The control group was assessed at corresponding time points.
Measured: Immediately before the intervention and immediately after its completion, approximately 15 minutes after the baseline assessment during active labor.
Secondary outcomes (1)
Duration of the Active Phase of Labor
The duration of the active phase of labor was calculated in minutes from the first documented cervical dilatation of 6 cm until birth, based on standardized partograph records. Higher values indicate a longer duration of labor.
Measured: From the first documentation of 6 cm cervical dilatation until birth, assessed up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Dec 2024
- Primary completion1 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving the Rebozo technique in addition to routine intrapartum care or the control group receiving routine intrapartum care alone. Outcomes will be compared between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Yildirim Varişoğlu, Istanbul University
- Investigators
- Yeliz YILDIRIM VARIŞOĞLU, Assoc. Prof., Study director, Istanbul UniversityGamze ÇERÇİNLİ, Midwife, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759479
- Sponsor's protocol ID
- 248/11.27.2024
- Acronym
- Rebozo Techniq
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the publication, after de-identification, will be made available upon reasonable request to the corresponding author. Data will be shared with qualified researchers for scientifically sound research purposes after approval of a methodologically appropriate research proposal. Supporting documents, including the study protocol and statistical analysis plan, may also be made available. Data will be available beginning six months after publication and ending five years after publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Rebozo Technique Applied During the Active Phase of Labor on Labor Pain Intensity and Labor Duration in Primiparous Women: A Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07759479
- Acronym / sponsor ID
- Rebozo Techniq / 248/11.27.2024
- Conditions
- Labor Pain, Labor Duration, Childbirth, Management of Delivery, Rebozo at Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Aug 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.
Study Description
Childbirth is a physiological process often accompanied by severe pain and prolonged labor, which may negatively affect maternal well-being and increase the likelihood of obstetric interventions. Non-pharmacological approaches that support physiological labor are recommended as part of evidence-based intrapartum care. The Rebozo technique is a traditional midwifery intervention involving rhythmic pelvic mobilization using a woven cloth to promote maternal comfort, facilitate fetal descent and rotation, and improve labor progression.
This single-center, parallel-group randomized controlled trial aims to evaluate the effectiveness of the Rebozo technique on labor pain intensity and labor duration among primiparous women during the active phase of labor. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group, receiving the Rebozo technique in addition to routine intrapartum care, or the control group, receiving routine intrapartum care alone.
The primary outcomes are labor pain intensity, assessed using the Visual Analog Scale (VAS), and labor duration, measured from the active phase of labor (6 cm cervical dilatation) until birth. The findings are expected to provide evidence regarding the effectiveness, feasibility, and clinical applicability of the Rebozo technique as a safe, low-cost, non-pharmacological intervention to support physiological childbirth and improve maternal intrapartum outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving the Rebozo technique in addition to routine intrapartum care or the control group receiving routine intrapartum care alone. Outcomes will be compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Rebozo Group | Experimental | Procedure: Rebozo technique, Other: Routine Intrapartum careParticipants allocated to this group received the Rebozo technique in addition to routine intrapartum care. The Rebozo technique was applied during the active phase of labor using a standardized protocol consisting of three sessions of approximately five minutes each. |
| Control Group | Active comparator | Other: Routine Intrapartum careParticipants allocated to the control group received routine intrapartum care according to the institutional labor management protocol. No Rebozo intervention was administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Primiparous women
- Aged 18-35 years
- Singleton pregnancy
- Cephalic fetal presentation
- Gestational age between 37 and 42 completed weeks
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Non-cephalic fetal presentation
- Previous uterine surgery
- Pregnancy complications requiring emergency obstetric intervention
- Planned cesarean birth
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 |
|---|---|---|
| Rebozo techniqueThe Rebozo technique is a standardized non-pharmacological intervention performed using a traditional woven cloth to provide rhythmic pelvic mobilization during the active phase of labor. The intervention was administered in three sessions of approximately five minutes each by a trained researcher in addition to routine intrapartum care. | Procedure or surgery | Rebozo Group |
| Routine Intrapartum careRoutine intrapartum care was provided according to the institutional clinical protocol and included maternal and fetal monitoring, assessment of labor progress, supportive midwifery care, and obstetric management when clinically indicated. | Other | Control Group, Rebozo Group |
Primary outcome
Labor Pain Intensity Assessed Using the Visual Analog Scale for Pain
Time frame: Immediately before the intervention and immediately after its completion, approximately 15 minutes after the baseline assessment during active labor.
Labor pain intensity was assessed using the 10-cm Visual Analog Scale for Pain, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and therefore a worse outcome. Scores were recorded immediately before and immediately after completion of the Rebozo intervention. The control group was assessed at corresponding time points.
1 secondary outcome
Duration of the Active Phase of Labor
Time frame: From the first documentation of 6 cm cervical dilatation until birth, assessed up to 24 hours.
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 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the publication, after de-identification, will be made available upon reasonable request to the corresponding author. Data will be shared with qualified researchers for scientifically sound research purposes after approval of a methodologically appropriate research proposal. Supporting documents, including the study protocol and statistical analysis plan, may also be made available. Data will be available beginning six months after publication and ending five years after publication.
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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.
Yeliz YILDIRIM VARIŞOĞLU, Assoc. Prof. study director
Istanbul University
Gamze ÇERÇİNLİ, Midwife principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebozo technique and Routine Intrapartum care in people with Labor Pain and Labor Duration, run by Istanbul 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 7 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 Aug 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 Assessed Using the Visual Analog Scale for Pain (time frame: Immediately before the intervention and immediately after its completion, approximately 15 minutes after the baseline assessment during active labor.). 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 12 Aug 2026.