Viewing Study NCT06824558


Ignite Creation Date: 2025-12-25 @ 12:10 AM
Ignite Modification Date: 2026-01-06 @ 10:00 AM
Study NCT ID: NCT06824558
Status: COMPLETED
Last Update Posted: 2025-02-13
First Post: 2025-01-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effects of the Use of Virgin Mary Herb in Childbirth
Sponsor: Uskudar University
Organization:

Study Overview

Official Title: Effect of Virgin Mary Herb Used in Birth on Duration, Pain and Fear of Childbirth: A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2025-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EVMHUBDPFC
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: