The Effect of Partner-Assisted Rebozo Application in the Intrapartum Period on Birth Fear, Pain and Satisfaction

July 22, 2025 updated by: dilan cömert, Istanbul University - Cerrahpasa
The World Health Organization (WHO) recommends the use of non-pharmacological methods for the relief of labor pain. The use of non-pharmacological methods in pain management helps women see their labor as a natural event and contributes to the reduction of cesarean section rates by increasing satisfaction with normal birth . The rebozo technique, a traditional method, originates from Latin America and is a non-invasive, non-drug practical application. The rebozo technique reduces or eliminates pain by creating rhythmic movements in the pelvic area. No study has been found evaluating the results of partner-assisted rebozo application in the intrapartum period. For this reason, it is important to conduct evidence-based studies examining the effects of the use of rebozo technique in labor. This randomized controlled study will contribute to the literature. For this purpose, this study was planned to examine the effects of partner-assisted rebozo application in the intrapartum period on fear of labor, pain, and labor satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Childbirth is a challenging and life-changing experience for women that has emotional and physical effects. Every woman wants to remember her childbirth as a positive process, but the pain and suffering that accompanies this process can affect the perception of the pregnant woman. A long labor can increase complications for the baby and the mother. Despite all this, adapting to labor pain increases women's satisfaction with the labor process. For this, it is necessary to adopt methods that can reduce the duration and intensity of labor pain to a safe range and thus facilitate adaptation to pain. The American College of Obstetricians and Gynecologists (ACOG) recommends appropriate interventions to relieve labor pain. The World Health Organization (WHO) recommends the use of non-pharmacological methods for the relief of labor pain. The use of non-pharmacological methods in pain management helps women see their birth as a natural event and increases satisfaction with normal birth, thus contributing to the reduction of cesarean section rates. The rebozo technique, a traditional method, originates from Latin America and is a non-invasive, non-drug practical application. The rebozo technique reduces or eliminates pain levels by creating rhythmic movements in the pelvic area. Rebozo can be used before, during and after birth. When applied during labor, it corrects fetal malpositions, allows the fetus to easily make cardinal movements, and accelerates the progression of labor. There are limited studies on the rebozo application in the literature. In studies, women stated that they relaxed during contractions and their attention shifted away from the pain. In Febby's (2019) study, it was stated that the mother felt more comfortable with the rebozo technique, that it caused a hug-like feeling in the mother, causing the release of oxytocin, which could make the birth process faster and less painful, and that it could increase the sense of comfort among mothers. In a qualitative study, it was reported that pregnant women felt physically good with the application of the rebozo technique, that it was effective in reducing pain, and that especially when applied by midwives, it created great satisfaction in the mother. The application of the technique by midwives during labor will ensure that the pregnant woman actively participates in the labor, establishes a relationship of trust between the midwife and the pregnant woman, helps the pregnant woman cope with the pain of labor, and increases satisfaction with the labor. In the literature, it has been determined that rebozo application in the active phase reduces anxiety level and pain score and increases satisfaction. In a study, it was stated that the rebozo technique increases the rate of fetal descent and cervical dilatation. In another study, it was determined that the length of the second stage of labor with the rebozo technique was 27.07 minutes shorter than the control group. There are limited clinical studies conducted in our country with the rebozo technique. There is no study evaluating the results of partner-assisted rebozo application in the intrapartum period. For this reason, it is important to conduct evidence-based studies examining the effects of the use of rebozo technique in labor. This randomized controlled study will contribute to the literature.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • İ̇stanbul
      • Zeyti̇nburnu, İ̇stanbul, Turkey, 34020
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being literate,
  • Knowing Turkish,
  • Being over 18 years of age,
  • Being primiparous,
  • Having a single fetus and cephalic presentation,
  • Being at term (37-42 weeks),
  • Not having risk factors during pregnancy (Preeclampsia, premature rupture of membranes, oligohydramnios and polyhydramnios, gestational diabetes, placental anomalies, intrauterine growth retardation, intrauterine dead fetus, fetal distress, macrosomic babies, etc.),
  • Being in the active phase of the first stage of labor,
  • Those who agree to participate in the research,
  • The spouse also agrees to participate in the research.

Exclusion Criteria:

  • Being multiparous,
  • Having multiple pregnancies,
  • Women with any chronic disease,
  • Women with a diagnosed psychiatric disease,
  • Pregnant women with spine and bone structure problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: husband supported rebozo group
In the partner-assisted rebozo group, information will be provided to the partner and the pregnant woman with the education booklet created during the latent phase and training will be provided. When the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal dilation, the data collection forms and scale forms determined for the pregnant woman in the partner-assisted rebozo group will be filled in before the rebozo application. Rebozo application will be applied to the pregnant woman for three contractions. A re-evaluation will be made after the rebozo application. The determined scales will be applied at the 4th hour in the postpartum period.
Other: Husband assisted rebozo application
At 4-5 cm, 6-7 cm and 8-9 cm, the pregnant woman will be given a rebozo by her husband.
Experimental: midwife assisted rebozo group
In the midwife-assisted rebozo group, information will be provided to the pregnant woman with the education booklet created during the latent phase and training will be provided. When the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal dilation, the data collection forms and scale forms determined for the pregnant woman in the midwife-assisted rebozo group will be filled in before the rebozo application. Rebozo application will be applied to the pregnant woman for three contractions. A re-evaluation will be made after the rebozo application. The determined scales will be applied at the 4th hour in the postpartum period.
Other: Midwife assisted rebozo application
The midwife will apply rebozo to the pregnant woman at 4-5 cm, 6-7 cm and 8-9 cm.
No Intervention: control group
In the control group, when the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal opening, the same measurements will be made and the woman will continue to receive routine care, and then the measurements will be repeated. In the 4th hour after birth, the determined scales will be applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: 8 hours
Visual analog scale (VAS): The pain levels of the participants will be evaluated with the Visual analog scale (VAS). It was developed by Bond and Pilowski in 1966 in order to describe the severity of pain in individuals numerically. This measurement tool is a 10 cm long ruler. While the expression "no pain" is written on the left end, the expression "unbearable pain" is written on the right end. Since it has linear properties, the difference between each increase is equal. It is the most commonly used single-dimensional scale type because it does not guide individuals with numbers due to its usage feature, the evaluation is easy and fast, and it gives results in a short time. A VAS value approaching 10 indicates that the pain is very severe, while a value approaching 0 is evaluated as the pain has decreased.
8 hours
Birth Satisfaction Scale:
Time Frame: 8 hours
Birth Satisfaction Scale: Participants' satisfaction levels will be assessed with the Birth Satisfaction Scale. The scale, which was developed to assess women's perceptions of birth, was developed by Martin and Fleming in 2009. Its Turkish validity and reliability were made by Çoşar Çetin and colleagues in 2015. The scale is Likert-type and is scored from 5 (Strongly agree) to 1 (Strongly disagree). Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, and 29 are scored reversely. The scale has 30 items and the possible score varies between 30-150. There is no cut-off point for the scale. As the score increases, satisfaction with birth increases. The scale has 3 sub-dimensions: Quality of care (home assessment, birth environment, adequate support and communication with healthcare personnel), personal characteristics of women (ability to cope with birth, sense of control, preparation for birth, communication with the baby), and stress experienced during the birth process (experiencing distre
8 hours
Fear of Childbirth Scale:
Time Frame: 8 hours
Fear of Childbirth Scale: Participants' fear levels will be assessed with the Fear of Childbirth Scale. The scale measures fear during childbirth. The scale, developed by Wijma et al. (2002), was validated in Turkish by Serçekuş et al. in 2017 for validity and reliability. The scale measuring fear during childbirth consists of 10 items. The scale takes 30-90 seconds to administer. Each item in the scale is asked to be scored from 1 (completely disagree) to 10 (completely agree). The possible scores from the scale are between 10-100. A high score indicates high fear. It is an extremely practical scale in terms of application. 5 items (1,3,5,7,10) in the scale are positive and 5 items (2,4,6,8,9) are negative. The 5 items with positive meanings on the scale are reverse scored. The scale can be applied to all multiparous and primiparous women who are admitted to the delivery room and have cervical dilatation of 3 cm or more. The Cronbach alpha reliability coefficient of the scale is 0.88
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: DİLAN C Phd Candidate, Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27.01.2025-1187899

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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