NCT07752693

Brief Summary

The main objective of this study is to examine the effect of the rebozo technique, applied with partner support, on labor pain and birth satisfaction in primiparous pregnant women. This research is planned as a randomized controlled experimental study. A total of 64 pregnant women, 32 in the control group and 32 in the experimental group, who meet the sample selection criteria and agree to participate in the study, will constitute the sample of the study. Participants included in the study will be administered the Informed Consent Form, the "Demographic Information Form" created by the researcher, the "Fathers' Participation in Birth Scale", VAS scoring, "Birth Care Guide", "Observation Form Regarding Labor" and the "Birth Satisfaction Scale". Data will be analyzed using appropriate statistical methods. It is expected that the results obtained will contribute to the use of non-pharmacological methods in the birthing process and the support of partner participation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

June 17, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

Rebozo TechniquePrimiparous PregnantSpousal SupportLaborBirth Satisfaction

Outcome Measures

Primary Outcomes (2)

  • Labor Pains

    The VAS pain score is used to assess labor pain, and pain intensity is rated on a scale of 0 to 10. 0 indicates no pain, while 10 indicates unbearable pain.

    The VAS pain assessment scale is a measurement used to evaluate labor from the active phase (5 cm) to the completion of the first stage (10 cm). The VAS pain score will be used from the beginning of active labor (5 cm) until the moment of birth (10 cm).

  • Birth Satisfaction

    The Birth Satisfaction Scale is used to assess birth satisfaction. This scale is a measurement tool administered to women who have had vaginal deliveries during the postpartum period. It consists of three sub-dimensions and a total of 10 items. The scale is a 5-point Likert-type scale, with options ranging from 0 (strongly disagree), 1 (disagree), 2 (neutral), 3 (agree), and 4 (strongly agree).

    The birth satisfaction scale is an assessment scale administered to women who have completed childbirth, within the first 24 hours after delivery.

Study Arms (2)

Control Group

NO INTERVENTION

In primiparous pregnant women in the active phase, routine midwifery care will be applied, and VAS scoring will be performed according to the stages of cervical effacement and dilation (3 times: 5cm, 6-8cm, 9-10cm).

Experimental Group

EXPERIMENTAL

The labor process will be recorded in the "Birth Care Guide" by the attending midwife, and routine midwifery care and rebozo technique will be applied. When dilation reaches 5 cm, a VAS I assessment will be performed on the pregnant woman before applying the rebozo technique, and cervical effacement, dilation, FHR, vital signs, head level, number and duration of contractions will be recorded in the "Birth Care Guide". Rebozo will be applied for 10 minutes between contractions using the technique chosen by the pregnant woman. 30 minutes after rebozo application, a VAS II assessment will be performed, and cervical effacement, dilation, FHR, vital signs, head level, number and duration of contractions will be recorded in the "Birth Care Guide". The same procedure will be applied when dilation reaches 6-8 cm and 9-10 cm.

Other: Rebozo Technique

Interventions

Rebozo technique is a traditional Mexican practice that involves relaxation, rhythmic rocking, pelvic mobilization, and position changes during pregnancy and childbirth. Theses and research examining the effects of this technique on labor indicate that the rebozo method can contribute to shortening labor time and allow the mother to be more active during delivery. In our study, unlike other rebozo techniques, the aim is to provide "partner support." The rebozo technique will be applied with partner support during the three active phases of cervical effacement and dilation (5cm, 6-8cm, and 9-10cm), and the results will be recorded.

Experimental Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the study was conducted on pregnant women, the gender of the participants must be female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those aged between 18 and 49,
  • Between 37-42 weeks of gestation,
  • Primiparous pregnancy,
  • In head presentation, the fetus is singular,
  • Those who have not been diagnosed with a high-risk pregnancy,
  • Someone who understands and can speak Turkish,
  • In the active phase (5cm and above),
  • The spouse is allowed to be present at the birth.

You may not qualify if:

  • Those who experienced adjustment problems in the study,
  • Patients who require an emergency cesarean section,
  • Pregnancy with a known high-risk diagnosis (IUGR, fetal anomaly, polyhydramnios or oligohydramnios, presentation anomaly, multiple pregnancy, preeclampsia, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çerkezköy State Hospital

Tekirdağ, 59000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Iversen ML, Midtgaard J, Ekelin M, Hegaard HK. Danish women's experiences of the rebozo technique during labour: A qualitative explorative study. Sex Reprod Healthc. 2017 Mar;11:79-85. doi: 10.1016/j.srhc.2016.10.005. Epub 2016 Oct 31.

    PMID: 28159133BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Beyza Halaç Bozkurt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are two separate groups: Experimental and Control. Each group consists of 32 individuals. The study includes a total of 64 participants. The experimental group undergoes rebozo technique during the active phase, while the control group receives routine midwifery care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MIDWIFE

Study Record Dates

First Submitted

June 17, 2026

First Posted

August 7, 2026

Study Start

May 1, 2026

Primary Completion

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

The "Voluntary Consent Form," which must be obtained from each pregnant woman at the beginning of the study, states that the researcher's personal information will be kept confidential, that it can only be reviewed by official authorities when necessary, and that only the results of the study may be published in the literature.

Locations