The Effect of Rebozo Application in the Intrapartum Period

NCT05583825 | Completed

• 1 other identifier: 4463
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Birth Order

Keywords

Rebozo App; Birth Pain; Anxiety; Birth Experience

Outcome Measures

Primary Outcomes (3)

• Visual Analog Skala (VAS)

  Visual analog scale is a measurement tool used to convert some values that cannot be measured numerically to digital. It measures the severity of pain in individuals. It is a 10 cm long ruler with the phrase "no pain" on the left end and the phrase "unbearable pain" on the right end.As the VAS value approaches 10, the pain is considered to be very severe, and as it approaches 0, the pain decreases.

  In order to determine the effect of rebose on pain, the pain level of women before and after reboza will be evaluated in each phase. Thus, "the change in pain level in approximately 7-10 minutes" will be evaluated in each phase.

• Spielberger State Anxiety Inventory

  The scale is used to reveal the anxiety experienced by the person at that moment. It is a self-evaluation type scale consisting of short statements. It consists of 20 items.The total score obtained from the scale varies between 20-80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. It is a four-degree scale ranging from "Not at all" to "Totally".

  To determine the effect of rebozo on state anxiety, the change in women's state anxiety level "(change within approximately 12-14 hours)" will be evaluated just before rebozo in the latent period and immediately after rebozo administration in tr.

• Birth Experience Scale-CEQ

  The purpose of the scale; to evaluate women's birth experiences in different contexts. The scale consists of four sub-dimensions including birth process, professional help/support, perceived security, participation in decisions and 22 items. The first 19 items in the scale are evaluated using a four-point Likert scale and the last three items are evaluated using the Visual Analogue Scale (VAS). The first 19 items are used by scoring from 1 to 4. Scoring is defined as: Totally agree = 1, Mostly agree = 2, Partially agree =3, Strongly disagree = 4. Since the 3rd, 5th, 8th, 9th and 20th items of the scale include negative statements, these items are scored reversed. As the score obtained from the scale increases, it is concluded that the woman has a positive birth experience.

  Both the rebozo group and the standard care group; It will be filled in the fourth stage of labor (within the first 4 hours after the delivery of the placenta).

Other Outcomes (2)

• Personal Information Form (Socio-demographic, obstetric characteristics and thoughts on the method)

  At the beginning of the study (in the latent phase), the socio-demographic and obstetric characteristics of women in both the Rebozo group and the standard care group will be evaluated. Then, women who received rebozo in the fourth stage of labor (within

• Travay Follow-up Form

  At the beginning of the study, sections where maternal and fetal findings can be recorded will be filled for women in both groups. All evaluations will continue to be recorded on the form during the period until the birth (average 12-14 hours).

Study Arms (2)

Rebozo Applied Group

EXPERIMENTAL

* 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.

Other: Rebozo App

Standard Care Group

NO INTERVENTION

* 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.

Interventions

Rebozo App 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.

Rebozo Applied Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (2)

• 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: 28159133 RESULT

• 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. 2026 Jan;37(1):137-147. doi: 10.1177/10436596251366932. Epub 2025 Sep 12.

  PMID: 40936453 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Yurdagül Yağmur, PhD

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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/.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 18, 2022
• Study Start: August 4, 2022
• Primary Completion: May 19, 2023
• Study Completion: August 31, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

TU (1)