Focusing on the Maryam's Flower During the Birth

The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth

To determine the Effect of Focusing on the Virgin Mary Flower during the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth.

Method: The study will be completed in a randomized controlled manner with a total of 126 primiparous pregnant women, 63 in the experimental group and 63 in the control group. Pregnant women in the experimental group will focus on the Virgin Mary flower in the water-filled jar and imagine that their uterus and birth path are opening like the branches of the Virgin Mary flower that blooms as labor pains come. There will be no intervention in the control group other than routine midwifery care. Research data will be collected with the Pregnant Introduction and Birth Process Follow-up Form, Visual Analog Scale, and Visual Similarity Scale for Fatigue.

Study Overview

• Status: Active, not recruiting
• Conditions: Labor Pain
• Intervention / Treatment: Other: Focusing on Maryam's Flower

Detailed Description

Design and Settings: This randomized controlled experimental study will conducted in the delivery room of the, Turkey between the dates of November 2023 and April 2024

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sümeyye BAL, Ph.D; Phone Number: 6424 03623121919; Email: sumeyyebal@gmail.com
• Study Contact Backup: Name: Sümeyye BAL; Phone Number: 6424 03623121919; Email: sumeyyebal@gmail.com

Study Locations

• Turkey
  • Samsun, Turkey, 55200
    • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being 18 years or older,
• being in 37-42 weeks of pregnancy,
• being primiparous,
• having a single healthy fetus,
• cervical dilatation not more than 3 cm.the one which,
• in the first stage of labor,
• Does not have any complications preventing vaginal birth,
• volunteer women who do not have disabilities in communication and perception

Exclusion Criteria:

• maternal and fetal complications
• pregnant with assisted reproductive techniques,
• having a presentation anomaly,
• having a twin pregnancy,
• electing cesarean section,
• Women whose cervical dilatation exceeds 3 cm and who are not willing to participate in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maryam's Flower Group; Maryam's flower will place in a bowl of water and left in the room of the pregnant women who will at 1 cm cervical dilatation and in the first phase of the labor. It will explain to the pregnant women that the leaves of the plant would open up in the water, and they will ask to imagine that the birth canal would simultaneously open up. In effect, they will told to focus on the opening of these leaves during the course of the labor.. After birth, the flower used only as a focusing method will be removed from the water and its water will be poured.	Other: Focusing on Maryam's Flower; Effect of Focusing on Maryam's Flower During the First Phase of the labor; Other Names: Foccusing on Maryam's Flower
No Intervention: control group; will provided with standard midwifery care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of labor pain by VAS	Visual Analog Scale: The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end	immediately after intervention
Visual Similarity Scale for Fatigue	The scale consists of two subscales, fatigue and energy, and 18 items. There are 10 cm long horizontal lines with positive expressions at one end and negative expressions at the other end of the YİBGS. While the items of the fatigue subscale progress from positive to negative, the energy subscale has the opposite order. The lowest score obtained from the fatigue subscale is 0 and the highest score is 130. In the energy subscale, scores range from 0 to 50.	immediately after intervention

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Chair: Sümeyye BAL, Ondokuz Mayıs University; Principal Investigator: Sümeyye BAL, Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): April 3, 2024
• Study Completion (Estimated): April 3, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2022/294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No