The Effects of the Use of Virgin Mary Herb in Childbirth

NCT ID: NCT06824558

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain During Labour Fear of Childbirth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

primiparous pregnant

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.

Group Type SHAM_COMPARATOR

primiparous pregnant

Intervention Type OTHER

Only midwifery care was applied to pregnant women in the control group.

primiparous pregnant woman following virgin mary

Pregnant women in the intervention group were shown the herb Mary taken in water during birth and also received midwifery care.

Group Type ACTIVE_COMPARATOR

primiparous pregnant woman following virgin mary

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

primiparous pregnant woman following virgin mary

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.

Intervention Type OTHER

primiparous pregnant

Only midwifery care was applied to pregnant women in the control group.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,

Exclusion Criteria

* 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
Minimum Eligible Age

18 Days

Maximum Eligible Age

45 Days

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uskudar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tuğba YILMAZ ESENCAN

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tugba YILMAZ ESENCAN, Assistant Professor

Role: STUDY_DIRECTOR

Uskudar University

Sumeyye ÇİFTÇİ, specialist midwife

Role: PRINCIPAL_INVESTIGATOR

Çam ve Sakura City Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uskudar University Faculty of Health Sciences

Istanbul, Ümraniye, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32792843 (View on PubMed)

Ali-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.

Reference Type BACKGROUND
PMID: 25900613 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Individual Participant Data Set

https://gcris.pau.edu.tr/bitstream/11499/6124/1/7ba3f584-23f9-4af0-9a4a-56f72570f94d.pdf

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Virgin Mary Herb Used in Birth

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.