NCT06128759

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

November 8, 2023

Last Update Submit

October 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Maryam's Flower Group

EXPERIMENTAL

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

control group

NO INTERVENTION

will provided with standard midwifery care.

Interventions

Effect of Focusing on Maryam's Flower During the First Phase of the labor

Also known as: Foccusing on Maryam's Flower
Maryam's Flower Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sümeyye BAL

    Ondokuz Mayıs University

    STUDY CHAIR
  • Sümeyye BAL

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

November 21, 2023

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations