Pain During LabourEVMHUBDPFCNCT06824558
The Effects of the Use of Virgin Mary Herb in Childbirth
A study testing primiparous pregnant woman following virgin mary and primiparous pregnant in people with Pain During Labour and Fear of Childbirth, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This is a study to see if the use of virgin mary herb during birth has an effect on fear, pain and duration during birth. Virgin mary herb is a dry plant and it is believed that when added to water during birth, it makes birth easier. Read more about this study
- Who is it for?
- Ages 18 to 45 days, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain During Labour, Fear of Childbirth
- What is being tested?
- primiparous pregnant woman following virgin mary and primiparous pregnant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2024to 31 Dec 2024
- 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 45 days
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Being over 18 years old,
- Being able to understand and speak Turkish,
- Being primiparous,
- Not having a chronic disease,
- Having completed the 37th week of pregnancy,
- Not having passed the 42nd week of pregnancy,
- Being in a cephalic presentation,
- Having reached 4cm cervical dilatation,
Who cannot join
- Multiparous pregnancy,
- Application of labor induction,
- Being a high-risk pregnancy,
- Having received childbirth preparation training,
- Being an immigrant,
- Use of non-pharmacological methods other than Virgin Mary
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University Faculty of Health Sciences
Istanbul, Umraniye, 34768
About this study
Official title: Effect of Virgin Mary Herb Used in Birth on Duration, Pain and Fear of Childbirth: A Randomized Controlled Trial
This is a study to see if the use of virgin mary herb during birth has an effect on fear, pain and duration during birth. Virgin mary herb is a dry plant and it is believed that when added to water during birth, it makes birth easier.
Read the detailed description
Objective: Midwives mostly develop nonpharmacological methods to cope with fear and pain management during birth in order not to interfere with the flow of birth. There are limited studies on traditional birth methods in Turkey. The aim of this study is to examine the effect of the use of the Virgin Mary Herb, one of the traditional methods applied during birth, on fear of birth and pain felt during birth. Material and Method: The universe of the study consists of all pregnant women who were admitted to the Birth Unit of a City Hospital in Istanbul between March 2023 and December 2023. A power analysis was conducted to determine the number of people to be included in the study sample. The power of the test was calculated with the G*Power 3.1 program. In order to exceed the 95% value in determining the power of the study; a total of 84 people, 42 people in groups, should be reached at a significance level of 5% and an effect size of 0.732 (df=82; t=1.66). The study aimed to reach a total of 100 people, with the condition of including 50 people in each group, considering the high power of the test and the losses. Data were collected between September 5, 2024 and December 31, 2024. 50 intervention groups and 50 control groups were included in the study, and all pregnant women received midwifery care. The intervention group was additionally shown the opening of the Virgin Mary Herb in water.
- Conditions
- Pain During Labour, Fear of Childbirth
- Being tested
- primiparous pregnant woman following virgin mary, primiparous pregnant
- Keywords
- Anastatica Hierochuntica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primiparous pregnant woman following virgin maryOther
It is thought that the application of the motherwort during birth shortens the duration of labor and reduces pain and fear during birth. In the study, the pregnant women in the intervention group watched the opening of the motherwort in water during birth.
primiparous pregnantOther
Only midwifery care was applied to pregnant women in the control group.
| Study group | Role | What they receive |
|---|---|---|
| primiparous pregnant | Sham comparator | Control group: Normal midwifery care is applied during birth and no other care is applied. Pregnant women are not shown the blossoming of the Virgin Mary plant in water as in the intervention group. Receives: Other: primiparous pregnant |
| primiparous pregnant woman following virgin mary | Active comparator | Pregnant women in the intervention group were shown the herb Mary taken in water during birth and also received midwifery care. Receives: Other: primiparous pregnant woman following virgin mary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Scale
It is a scale developed by Serçekuş, İşbir and İnci in 2017. The Turkish form of the Fear of Childbirth Scale is a measurement tool that can accurately measure fear during childbirth, can be applied to Turkish culture, and is suitable in terms of language and content validity. The scale is a practical and fast tool to determine the degree of fear during childbirth and has been recommended to be used to determine the degree of fear of women in delivery rooms. Detection of fear during childbirth can allow continuous supportive care (emotional, informative support, relaxation, etc.) during childbirth, allowing the woman to have a better birth experience. Therefore, the Fear of Childbirth Scale can be used by professionals to determine the degree of fear of women in delivery rooms. The scale consists of 10 questions. Each question was scored between 1 and 10. The higher the score, the higher the fear.
Measured: After the pregnant woman started labor(when cervical dilatation was 4cm and above), the application was started. Labor lasted on average 24 hours.During this time the pregnant woman was assessed 3 times
Secondary outcomes (1)
Visual Analog Scale (VAS)
VAS was developed to be used in converting some values that cannot be measured quantitatively into numerical values. In VAS, where pain intensity is evaluated, pain intensity is graded between 0 and 10 points. "No pain" is graded as 0 points and "very severe pain" is graded as 10 points. Pain intensity of "less than 3 points" is indicated as mild pain, "between 3-6 points" as moderate pain, and "more than 6 points" as severe pain. It is seen that the pain increases as the score given increases.
Measured: After the pregnant woman started labor(when cervical dilatation was 4cm and above), the application was started.Labor lasted on average 24 hours.During this time the pregnant woman was assessed 3times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start31 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Pain During LabourStudies of the same condition, open and under way.
- 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 researcher will provide the Virgin Mary herb. A Virgin Mary herb plant will be used for each pregnant woman. The herb will be weighed with a precision scale to ensure that it is the same size and weight. The intervention group will be asked to fill out the same data collection tools by watching 100 grams of Virgin Mary herb in a standard wide-mouthed glass bowl at 50 degrees and put in a container full of water. The monitoring period of the Virgin Mary herb will be recorded in the Virgin Mary Herb Monitoring Form and the visuals during this time will be photographed and monitored through this form. At the same time, the labor will be monitored with the midwifery care provided by the researcher midwife throughout the progress of the labor. The pregnant woman will be told to imagine that her cervix is opening in this way while watching the herb opening. The details regarding the application (monitoring period of Anastatica Hierochuntica) will be recorded by
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
- Investigators
- Tugba YILMAZ ESENCAN, Associate Professor, Study director, Uskudar UniversitySumeyye ÇİFTÇİ, specialist midwife, Principal investigator, Çam ve Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824558
- Sponsor's protocol ID
- Virgin Mary Herb Used in Birth
- Acronym
- EVMHUBDPFC
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be published in Yöktez.
Publications
Rameshbabu S, Messaoudi SA, Alehaideb ZI, Ali MS, Venktraman A, Alajmi H, Al-Eidi H, Matou-Nasri S. Anastatica hierochuntica (L.) methanolic and aqueous extracts exert antiproliferative effects through the induction of apoptosis in MCF-7 breast cancer cells. Saudi Pharm J. 2020 Aug;28(8):985-993. doi: 10.1016/j.jsps.2020.06.020. Epub 2020 Jul 9.
PubMed 32792843Ali-Shtayeh MS, Jamous RM, Jamous RM. Plants used during pregnancy, childbirth, postpartum and infant healthcare in Palestine. Complement Ther Clin Pract. 2015 May;21(2):84-93. doi: 10.1016/j.ctcp.2015.03.004. Epub 2015 Apr 2.
PubMed 25900613
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virgin Mary Herb Used in Birth on Duration, Pain and Fear of Childbirth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06824558
- Acronym / sponsor ID
- EVMHUBDPFC / Virgin Mary Herb Used in Birth
- Conditions
- Pain During Labour, Fear of Childbirth
- Keywords
- Anastatica Hierochuntica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 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 is a study to see if the use of virgin mary herb during birth has an effect on fear, pain and duration during birth. Virgin mary herb is a dry plant and it is believed that when added to water during birth, it makes birth easier.
Detailed description
Objective: Midwives mostly develop nonpharmacological methods to cope with fear and pain management during birth in order not to interfere with the flow of birth. There are limited studies on traditional birth methods in Turkey. The aim of this study is to examine the effect of the use of the Virgin Mary Herb, one of the traditional methods applied during birth, on fear of birth and pain felt during birth. Material and Method: The universe of the study consists of all pregnant women who were admitted to the Birth Unit of a City Hospital in Istanbul between March 2023 and December 2023. A power analysis was conducted to determine the number of people to be included in the study sample. The power of the test was calculated with the G*Power 3.1 program. In order to exceed the 95% value in determining the power of the study; a total of 84 people, 42 people in groups, should be reached at a significance level of 5% and an effect size of 0.732 (df=82; t=1.66). The study aimed to reach a total of 100 people, with the condition of including 50 people in each group, considering the high power of the test and the losses. Data were collected between September 5, 2024 and December 31, 2024. 50 intervention groups and 50 control groups were included in the study, and all pregnant women received midwifery care. The intervention group was additionally shown the opening of the Virgin Mary Herb in water.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The researcher will provide the Virgin Mary herb. A Virgin Mary herb plant will be used for each pregnant woman. The herb will be weighed with a precision scale to ensure that it is the same size and weight. The intervention group will be asked to fill out the same data collection tools by watching 100 grams of Virgin Mary herb in a standard wide-mouthed glass bowl at 50 degrees and put in a container full of water. The monitoring period of the Virgin Mary herb will be recorded in the Virgin Mary Herb Monitoring Form and the visuals during this time will be photographed and monitored through this form. At the same time, the labor will be monitored with the midwifery care provided by the researcher midwife throughout the progress of the labor. The pregnant woman will be told to imagine that her cervix is opening in this way while watching the herb opening. The details regarding the application (monitoring period of Anastatica Hierochuntica) will be recorded by
| Arm | Type | Receives |
|---|---|---|
| primiparous pregnant | Sham comparator | Other: primiparous pregnantControl group: Normal midwifery care is applied during birth and no other care is applied. Pregnant women are not shown the blossoming of the Virgin Mary plant in water as in the intervention group. |
| primiparous pregnant woman following virgin mary | Active comparator | Other: primiparous pregnant woman following virgin maryPregnant women in the intervention group were shown the herb Mary taken in water during birth and also received midwifery care. |
Who may qualify
- Ages
- 18 to 45 days
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Being over 18 years old,
- Being able to understand and speak Turkish,
- Being primiparous,
- Not having a chronic disease,
- Having completed the 37th week of pregnancy,
Key exclusion criteria (6 listed)
- Multiparous pregnancy,
- Application of labor induction,
- Being a high-risk pregnancy,
- Having received childbirth preparation training,
- Being an immigrant,
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 |
|---|---|---|
| primiparous pregnant woman following virgin maryIt is thought that the application of the motherwort during birth shortens the duration of labor and reduces pain and fear during birth. In the study, the pregnant women in the intervention group watched the opening of the motherwort in water during birth. | Other | primiparous pregnant woman following virgin mary |
| primiparous pregnantOnly midwifery care was applied to pregnant women in the control group. | Other | primiparous pregnant |
Primary outcome
Fear Scale
Time frame: After the pregnant woman started labor(when cervical dilatation was 4cm and above), the application was started. Labor lasted on average 24 hours.During this time the pregnant woman was assessed 3 times
It is a scale developed by Serçekuş, İşbir and İnci in 2017. The Turkish form of the Fear of Childbirth Scale is a measurement tool that can accurately measure fear during childbirth, can be applied to Turkish culture, and is suitable in terms of language and content validity. The scale is a practical and fast tool to determine the degree of fear during childbirth and has been recommended to be used to determine the degree of fear of women in delivery rooms. Detection of fear during childbirth can allow continuous supportive care (emotional, informative support, relaxation, etc.) during childbirth, allowing the woman to have a better birth experience. Therefore, the Fear of Childbirth Scale can be used by professionals to determine the degree of fear of women in delivery rooms. The scale consists of 10 questions. Each question was scored between 1 and 10. The higher the score, the higher the fear.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: After the pregnant woman started labor(when cervical dilatation was 4cm and above), the application was started.Labor lasted on average 24 hours.During this time the pregnant woman was assessed 3times
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 3 Sep 2026.
- Background: PubMed 32792843Rameshbabu S, Messaoudi SA, Alehaideb ZI, Ali MS, Venktraman A, Alajmi H, Al-Eidi H, Matou-Nasri S. Anastatica hierochuntica (L.) methanolic and aqueous extracts exert antiproliferative effects through the induction of apoptosis in MCF-7 breast cancer cells. Saudi Pharm J. 2020 Aug;28(8):985-993. doi: 10.1016/j.jsps.2020.06.020. Epub 2020 Jul 9.
- Background: PubMed 25900613Ali-Shtayeh MS, Jamous RM, Jamous RM. Plants used during pregnancy, childbirth, postpartum and infant healthcare in Palestine. Complement Ther Clin Pract. 2015 May;21(2):84-93. doi: 10.1016/j.ctcp.2015.03.004. Epub 2015 Apr 2.
- Fear of Childbirth ScaleLink provided by the sponsor.
- Intervention for Fear of Childbirth: HypnobirthingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study will be published in Yöktez.
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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.
Tugba YILMAZ ESENCAN, Associate Professor study director
Uskudar University
Sumeyye ÇİFTÇİ, specialist midwife principal investigator
Çam ve Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primiparous pregnant woman following virgin mary and primiparous pregnant in people with Pain During Labour and Fear of Childbirth, run by Uskudar 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 8 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 3 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
Fear Scale (time frame: After the pregnant woman started labor(when cervical dilatation was 4cm and above), the application was started. Labor lasted on average 24 hours.During this time the pregnant woman was assessed 3 times). 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 NCT06824558, 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 3 Sep 2026.