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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06128759
Other study ID # 2022/294
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2023
Est. completion date April 3, 2024

Study information

Verified date April 2024
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date April 3, 2024
Est. primary completion date April 3, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Ondokuz Mayis University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 YIBGS. 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
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