The Effect of Rebozo Application in the Intrapartum Period

NCT ID: NCT05583825

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-04

Study Completion Date

2023-08-31

Brief Summary

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This research, which was planned as a randomized experimental control study with intervention to determine the effect of Rebozo application applied to primiparous women during labor, on labor pain, anxiety and birth experience, will be conducted in the Birth Hall of Şanlıurfa Training and Research Hospital. The universe of the research consists of pregnant women who were admitted to the Delivery Hall to perform the labor, and the sample will be a minimum of 62 pregnant women, 31 in the experimental group and 31 in the control group. Research data will be collected by face-to-face interview method using Personal Information Form, Tramway Follow-up Form, Visual Analog Scale (VAS), Spielberger State Anxiety Inventory and Birth Experience Scale. From the pregnant women who met the sampling criteria to the women included in the intervention group; Rebozo techniques will be applied two or three times in each phase (latent phase, active phase and transitional phase), and pregnant women in the control group will not be subjected to any application other than routine hospital applications.

SPSS 24.0 package program will be used in the analysis of the data, and it will be evaluated with descriptive analyzes and correlation analyzes.

With the findings to be obtained as a result of the study, the effect of Rebozo applied to primiparous women during labor on labor pain, anxiety and birth experience will be determined. In addition, scientific evidence for the application of Rebozo will be provided with the data to be obtained.

Detailed Description

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Birth is one of the most important life experiences of a woman throughout her life. perceived pain at birth; it is a subjective condition that has different feelings for each woman and is affected by physiological, psychological, cultural and environmental factors. In addition to being a physiological indicator of the progress of labor, labor pain, which is multidimensional, can adversely affect maternal and fetal health if an effective pain management is not applied. Therefore, the American Society of Obstetrics and Gynecology (ACOG) recommends appropriate interventions to alleviate labor pain. The application of non-pharmacological methods in the management of pain allows women to see birth as a natural event, but it can be effective in reducing cesarean rates by increasing the satisfaction of the pregnant woman in normal vaginal delivery. In addition, supportive applications in the intrapartum period; It is known to be effective on shortening the birth period, positive outcomes for mothers and newborns, and positive birth and care experiences.

Among the non-pharmacological applications, one of the traditional applications, the Latin American origin, non-invasive Rebozo Technique is located. Rebozo is a long and colorful fabric, two meters long and 70 cm wide, worn by Mexican women on their head and shoulders. Rebozo application is to relieve pain by creating a rhythmic movement in the mother's pelvis and to help the fetus enter a suitable position for delivery by relaxing the pelvic muscles. In addition to relieving pain; It can be applied to many parts of the body because it is effective in times such as low back pain, stress, fatigue, the need for a position change in the baby's womb. This technique is used by midwives or nurses in various positions while the woman is lying down, standing, or on her hands and knees in childbirth. In addition, it can be applied between 5-10 minutes during contractions, or this time can be extended or shortened according to the woman's preference.

Conditions

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Birth Order

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The status of the participants in the experimental or control group was determined by simple random sampling method. Accordingly, the sample calculation was created by logging into the site https://www.randomizer.org/.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Rebozo Applied Group

* Those who are in the latent phase (cervical opening 1-4 cm) will be provided to sign the informed consent form by making a statement regarding the research. The Personal Information Form will be filled and the anxiety levels of women with a cervical dilation of 3-4 cm will be determined with the State Anxiety Inventory and the pain level will be determined with the Visual Analog Scale, and rebozo techniques will be applied two or three times. After the application, the level of pain will be re-evaluated.
* When the cervical dilation is 6-7 cm (active phase), the pain level will be determined with the Visual Analog Scale, Rebozo Techniques will be applied two or three times and the pain level will be re-evaluated after the application.
* When the cervical opening is 8-9 cm (transition phase), the pain level will be determined, Rebozo Techniques will be applied two or three times, and anxiety and pain levels will be evaluated after the application.

Group Type EXPERIMENTAL

Rebozo App

Intervention Type OTHER

It is a non-invasive, non-drug practical application made with Rebozo, a long and colorful fabric, two meters long and 70 cm wide, worn by Mexican women on their head and shoulders.

Standard Care Group

* Pregnant women who will not be subjected to any application other than routine hospital applications, who are in the latent phase (cervical opening 1-4 cm), will be provided to sign the informed consent form by making a statement about the research. Afterwards, by filling out the Personal Information Form, the anxiety levels of women with a cervical dilation of 3-4 cm will be determined with the State Anxiety Inventory, and their pain levels will be determined with the Visual Analog Scale.
* When the cervical opening is 6-7 cm (active phase), the level of pain will be determined.
* When the cervical dilation is 8-9 cm (transition phase), anxiety and pain levels will be determined.
* The Travay Follow-up Form will be used in the period from the admission of women to labor until the end of the action.
* Evaluation of birth experience will be done in the fourth stage of labor using the birth experience scale.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rebozo App

It is a non-invasive, non-drug practical application made with Rebozo, a long and colorful fabric, two meters long and 70 cm wide, worn by Mexican women on their head and shoulders.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* over 18 years ,
* Able to communicate
* Having a single-vertex and healthy fetus at term,
* No disability or disease,
* Primiparous women who agreed to participate in the study.

Exclusion Criteria

* Those who are administered sedative and pharmacological drugs during the action process,
* Those who develop maternal or fetal complications,
* Those who received cesarean section for any reason,
* Those who want to leave the research.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Zeliha Turan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yurdagül Yağmur, PhD

Role: STUDY_CHAIR

Inonu University

Locations

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Inonu University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 28159133 (View on PubMed)

Turan Z, Yagmur Y. The Effect of Rebozo Massage on Birth Pain, Anxiety, and Childbirth Experience in the Intrapartum Period: A Randomized Controlled Trial in Turkiye. J Transcult Nurs. 2025 Sep 12:10436596251366932. doi: 10.1177/10436596251366932. Online ahead of print.

Reference Type DERIVED
PMID: 40936453 (View on PubMed)

Other Identifiers

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4463

Identifier Type: -

Identifier Source: org_study_id

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