NCT06847893

Brief Summary

This study was designed as a randomized controlled, 2-group, experimental study to measure the levels of perceived birth support and control between women with and without rebozo technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 8, 2025

Last Update Submit

February 25, 2025

Conditions

Keywords

rebozosupportcontrolpregnantbirth

Outcome Measures

Primary Outcomes (1)

  • Perception of Control and Support in the Birth Scale

    The scale was developed by Elizabeth Ford, Susan Ayers and Daniel B. Wright in 2009 under the name Support and Control in Childbirth Scale (SCBS). The Turkish validation of the scale was conducted by Figen İnci, Gözde Gökçe İşbir and Fuat Tanhan in 2015. The scale consists of 33 items and three sub-dimensions: support, control and external control. The sub-dimensions are the health worker's support dimension items 1-12 and the mother's control over her own body and birth sub-dimension items 13-33. The scale is a five-point Likert-type scale as "Strongly Agree", "Agree", "Undecided", "Disagree", "Strongly Disagree". There are 10 negative statements in the scale. The scores that can be obtained from the DCOS scale range from 33 to 165 and these scores were used to determine the level of control and support perceived by women. Cronbach's alpha coefficient of the scale is 0.84. In this study, Cronbach's alpha coefficient was found to be 0.973.

    4 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

After the randomization of the women placed in the clinic, they were informed about the study and their consent was obtained; then the Introductory Information Form was completed. The experimental group (n=22) received massage with rebozo technique during the active phase of labor in addition to routine care in accordance with clinical procedures. A 'Rebozo Application Calendar' was created for the experimental group. According to this calendar, 4 rebozo techniques were determined. The duration and frequency of the techniques and the cervical dilatation of the pregnant woman at the time of application were recorded. After delivery, the 'Perceived Support and Control in Childbirth Scale' was completed. Translated with DeepL.com (free version)

Other: rebozo technique

control group

NO INTERVENTION

After the randomization of the women placed in the clinic, they were informed about the study and their consent was obtained; then the Introductory Information Form was completed. The control group (n=22) received routine midwifery care only in accordance with clinical procedures. A 'Rebozo Implementation Schedule' was created for the participants in the experimental group. According to this schedule, rebozo techniques to be applied in the latent and active phase of labor were determined. The duration and frequency of the rebozo techniques and the cervical dilatation of the pregnant woman when the technique was applied were recorded. After delivery, the 'Perceived Support and Control in Labor Scale' was completed.

Interventions

In accordance with the 'Rebozo Chart' developed by the researcher, the pregnant women in the experimental group were massaged with 4 different rebozo techniques (rebozo technique in hand-knee position, rebozo technique in knee-chest position, umbilical support with rebozo, rebozo technique applied with Pilates ball) in the active phase of labor. After the application, the duration, frequency and cervical dilatation of the pregnant woman were recorded in the chart.

Experimental Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince pregnancy takes place in the woman's body, it is a woman-oriented study and primiparous women who have completed the gestational period were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the research,
  • Don't speak Turkish,
  • Being literate,
  • Having a low-risk pregnancy,
  • Primiparous pregnancy

You may not qualify if:

  • Being out of position
  • Having a high-risk pregnancy (vaginal bleeding, no hypertension, etc.),
  • Dilatation below 4 cm and above 6 cm,
  • Initiation of labor induction,
  • Having received childbirth preparation training,
  • Absence of a birth attendant in trauma,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Ümraniye, Turkey (Türkiye)

Location

Study Officials

  • Ayça DEMİR YILDIRIM, PhD

    Üsküdar University NP Health Campus Institute of Health Sciences Department of Midwifery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The numbers from 1 to 44 were randomly divided into two groups on the random.org website and randomly selected numbers were assigned to the intervention and control groups. This process ensured equal and random distribution of participants to the intervention and control groups. The group to which the case was assigned was determined according to the order of hospitalization and recorded in the Excel list. Since the care intervention and data collection were performed by the researcher in the study, one-way blinding was performed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was designed as a randomized controlled, 2-group (intervention and control), experimental research.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Faculty Member

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 26, 2025

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 30, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

A research article is planned to make the individual participant data (IPD) available to other researchers.

Locations