Focusing on the Maryam's Flower During the Birth

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06128759
Collaborator
(none)
126
2
2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Focusing on Maryam's Flower
N/A

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 February 2024

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Focusing on the Maryam's Flower During the Birth Process on Labor Pain, Labor Duration and Perceived Fatigue in Birth
Anticipated Study Start Date :
Nov 21, 2023
Anticipated Primary Completion Date :
Feb 3, 2024
Anticipated Study Completion Date :
Feb 3, 2024

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. severity of labor pain by VAS [immediately after intervention]

      Visual Analog Scale: The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end

    2. Visual Similarity Scale for Fatigue [immediately after intervention]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ondokuz Mayıs University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sümeyye BAL, Ph.D., Ondokuz Mayıs University
    ClinicalTrials.gov Identifier:
    NCT06128759
    Other Study ID Numbers:
    • 2022/294
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 15, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2023