Effects of the Rebozo Technique During Active Labor on Labor Pain and Labor Duration in Primiparous Women

NCT07759479 | Completed

• 1 other identifier: 248/11.27.2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Labor Pain; Labor Duration; Childbirth; Management of Delivery; Rebozo at Birth

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From the first documentation of 6 cm cervical dilatation until birth, assessed up to 24 hours.

Study Arms (2)

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.

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.

Other: Routine Intrapartum care

Interventions

Rebozo technique PROCEDURE

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.

Rebozo Group

Routine Intrapartum care OTHER

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.

Control Group; Rebozo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women
• Aged 18-35 years
• Singleton pregnancy
• Cephalic fetal presentation
• Gestational age between 37 and 42 completed weeks
• Spontaneous onset of labor
• Cervical dilatation of 6 cm (active phase of labor)
• No contraindication to vaginal birth
• Able to communicate in Turkish
• Provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeliz YILDIRIM VARIŞOĞLU, Assoc. Prof.

  Istanbul University

  STUDY DIRECTOR

• Gamze ÇERÇİNLİ, Midwife

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of participants and care providers was not feasible. Outcome measures were collected using standardized procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 30, 2025
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Access will be provided to qualified researchers whose proposed use of the data has been approved by the corresponding author following review of a scientifically sound research proposal.

Locations

TU (1)