NCT06824558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

January 23, 2025

Last Update Submit

February 7, 2025

Conditions

Keywords

Anastatica Hierochuntica

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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

Study Arms (2)

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.

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.

Other: primiparous pregnant woman following virgin mary

Interventions

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 pregnant woman following virgin mary

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

primiparous pregnant

Eligibility Criteria

Age18 Days - 45 Days
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was conducted on primiparous pregnant women.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University Faculty of Health Sciences

Istanbul, Ümraniye, 34662, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32792843BACKGROUND
  • 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.

    PMID: 25900613BACKGROUND

Related Links

Study Officials

  • Tugba YILMAZ ESENCAN, Assistant Professor

    Uskudar University

    STUDY DIRECTOR
  • Sumeyye ÇİFTÇİ, specialist midwife

    Çam ve Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 13, 2025

Study Start

May 31, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

The study will be published in Yöktez.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The work started on May 1 and ended on December 31.
Access Criteria
The study can be accessed by entering Yöktez and typing the name of the study or the names of the administrators.
More information

Available IPD Datasets

Individual Participant Data Set (Fear of Childbirth Scale)Access
Individual Participant Data Set (Fear of Childbirth Scale)Access

Locations