Clinical trial NCT06824558: The Effects of the Use of Virgin Mary Herb in Childbirth
Official title: Effect of Virgin Mary Herb Used in Birth on Duration, Pain and Fear of Childbirth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain During Labour
Fear of Childbirth
Keywords: Anastatica Hierochuntica
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fear Scale
timeFrame: 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:
measure: Visual Analog Scale (VAS)
timeFrame: 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
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Uskudar University Faculty of Health Sciences
state: Ümraniye
Study officials:
affiliation: Uskudar University
name: Tugba YILMAZ ESENCAN, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Çam ve Sakura City Hospital
name: Sumeyye ÇİFTÇİ, specialist midwife
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.