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NCT Number: NCT05583825

The Effect of Rebozo Application in the Intrapartum Period

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.

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Key information

Conditions

Birth Order Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual Analog Skala (VAS)

    Time frame: 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.

    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.

  2. Spielberger State Anxiety Inventory

    Time frame: 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.

    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".

  3. Birth Experience Scale-CEQ

    Time frame: 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).

    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.

Other outcomes

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

    Time frame: 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

    This form, which was developed by the researcher in line with the literature, consists of five questions containing the socio-demographic characteristics of the women participating in the research (age, education level, employment status, income status, place of residence); five questions including obstetric characteristics (week of pregnancy, planned pregnancy, preparation for birth and training to cope with labor and fear of the birth process); and how the woman evaluates the Rebozo application (the effectiveness of the application on pain, fear/anxiety, whether the application is repeated and recommended, the problems experienced during the application), a total of 15 questions.

  2. Travay Follow-up Form

    Time frame: 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).

    This form, which was developed by the researcher on the basis of the Partograph Form, was prepared in order to follow the process from the admission of the participants in the study to the delivery. Vaginal examination findings according to the stages of labor, fetal heart rate, contraction characteristics, dose and time of the drugs used, time of birth, duration of the second stage, episiotomy and laceration status, gender, height and weight of the newborn, and APGAR scores at 1 and 5 minutes. place is given.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effect of Rebozo Application in the Intrapartum Period on Labor Pain, Anxiety and Birth Experience

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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