Clinical trial NCT05583825: The Effect of Rebozo Application in the Intrapartum Period
Official title: The Effect of Rebozo Application in the Intrapartum Period on Labor Pain, Anxiety and Birth Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Order
Keywords: Rebozo App
Birth Pain
Anxiety
Birth Experience
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Skala (VAS)
timeFrame: 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.
measure: Spielberger State Anxiety Inventory
timeFrame: 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.
measure: Birth Experience Scale-CEQ
timeFrame: 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).
Secondary outcomes:
Other outcomes:
measure: Personal Information Form (Socio-demographic, obstetric characteristics and thoughts on the method)
timeFrame: 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
measure: Travay Follow-up Form
timeFrame: 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).
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Yurdagül Yağmur, PhD
role: STUDY_CHAIR
References:
citation: 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.