Pregnant WomenNCT06847893
The Effect of Rebozo Technique on Perceived Support and Control in Childbirth
A study testing rebozo technique in people with Pregnant Women, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- rebozo technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the research,
- Don't speak Turkish,
- Being literate,
- Having a low-risk pregnancy,
- Primiparous pregnancy
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objective: This study was conducted to measure the perceived support during labor and the level of control over their own labor in pregnant women who underwent rebozo technique.
Method: The study was conducted in a randomized controlled experimental design between September and December 2024. The population of the study consisted of 44 primiparous pregnant women admitted to a district state hospital for delivery. The sample size was calculated and the study was conducted with 44 pregnant women (experiment: 22, control: 22). While rebozo technique was applied to the experimental group during the trauma process, routine midwifery care was applied to the control group. Introductory Information Form, Perceived Support and Control Scale in Childbirth were used to collect data in the study.
- Conditions
- Pregnant Women
- Being tested
- rebozo technique
- Keywords
- rebozo, support, control, pregnant, birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebozo techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Sep 2024
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a randomized controlled, 2-group (intervention and control), experimental research.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa
- Investigators
- Ayça DEMİR YILDIRIM, PhD, Principal investigator, Üsküdar University NP Health Campus Institute of Health Sciences Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847893
- Sponsor's protocol ID
- Ü.Ü. Ebe Büşra Ata
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A research article is planned to make the individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rebozo Technique on Perceived Support and Control in Childbirth
- ClinicalTrials.gov ID
- NCT06847893
- Acronym / sponsor ID
- Ü.Ü. Ebe Büşra Ata
- Conditions
- Pregnant Women
- Keywords
- rebozo, support, control, pregnant, birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: This study was conducted to measure the perceived support during labor and the level of control over their own labor in pregnant women who underwent rebozo technique.
Method: The study was conducted in a randomized controlled experimental design between September and December 2024. The population of the study consisted of 44 primiparous pregnant women admitted to a district state hospital for delivery. The sample size was calculated and the study was conducted with 44 pregnant women (experiment: 22, control: 22). While rebozo technique was applied to the experimental group during the trauma process, routine midwifery care was applied to the control group. Introductory Information Form, Perceived Support and Control Scale in Childbirth were used to collect data in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was designed as a randomized controlled, 2-group (intervention and control), experimental research.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: rebozo techniqueAfter 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) |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the research,
- Don't speak Turkish,
- Being literate,
- Having a low-risk pregnancy,
- Primiparous pregnancy
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rebozo techniqueIn 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. | Other | Experimental Group |
Primary outcome
Perception of Control and Support in the Birth Scale
Time frame: 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No. A research article is planned to make the individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça DEMİR YILDIRIM, PhD principal investigator
Üsküdar University NP Health Campus Institute of Health Sciences Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rebozo technique in people with Pregnant Women, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Control and Support in the Birth Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.