The Effects of the Use of Virgin Mary Herb in Childbirth (EVMHUBDPFC)

February 7, 2025 updated by: Tuğba YILMAZ ESENCAN, Uskudar University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ümraniye
      • İstanbul, Ümraniye, Turkey, 34662
        • Üsküdar University Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
Other: primiparous pregnant
Only midwifery care was applied to pregnant women in the control group.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Director: Tugba YILMAZ ESENCAN, Assistant Professor, Uskudar University
  • Principal Investigator: Sumeyye ÇİFTÇİ, specialist midwife, Çam ve Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Virgin Mary Herb Used in Birth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study will be published in Yöktez.

IPD Sharing Time Frame

The work started on May 1 and ended on December 31.

IPD Sharing Access Criteria

The study can be accessed by entering Yöktez and typing the name of the study or the names of the administrators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: Fear of Childbirth Scale
    Information comments: https://gcris.pau.edu.tr/bitstream/11499/6124/1/7ba3f584-23f9-4af0-9a4a-56f72570f94d.pdf
  2. Individual Participant Data Set
    Information identifier: Fear of Childbirth Scale

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fear of Childbirth

Clinical Trials on primiparous pregnant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe