Birth OrderNCT05583825
The Effect of Rebozo Application in the Intrapartum Period
A study testing Rebozo App in people with Birth Order, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Order
- What is being tested?
- Rebozo App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2022to 31 Aug 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Rebozo Application in the Intrapartum Period on Labor Pain, Anxiety and Birth Experience
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.
Read the 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.
- Conditions
- Birth Order
- Being tested
- Rebozo App
- Keywords
- Rebozo App, Birth Pain, Anxiety, Birth Experience
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebozo AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start4 Aug 2022
- Primary completion19 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Birth OrderStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Factorial
- 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/.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Turan, Inonu University
- Investigators
- Yurdagül Yağmur, PhD, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583825
- Sponsor's protocol ID
- 4463
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28159133Turan 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.
PubMed 40936453
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rebozo Application in the Intrapartum Period on Labor Pain, Anxiety and Birth Experience
- ClinicalTrials.gov ID
- NCT05583825
- Acronym / sponsor ID
- 4463
- Conditions
- Birth Order
- Keywords
- Rebozo App, Birth Pain, Anxiety, Birth Experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Oct 2022 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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/.
| Arm | Type | Receives |
|---|---|---|
| Rebozo Applied Group | Experimental | Other: Rebozo App* 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 AppIt 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. | Other | Rebozo Applied Group |
Primary outcome
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.
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".
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.
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 19 Mar 2024.
- Results publication: PubMed 28159133Iversen 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.
- Derived from this study: PubMed 40936453Turan 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.
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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.
Yurdagül Yağmur, PhD study chair
Inonu University
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 App in people with Birth Order, run by Inonu University 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 4 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 19 Mar 2024. 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?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583825, which also lists 2 linked publications.
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 19 Mar 2024.