NCT07175337

Brief Summary

This randomized controlled trial was conducted to determine the effects of spiritual support provided by Virgin Mary's hand plant and Surah Maryam on labor anxiety, labor pain, and satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 6, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 21, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Virgin Mary's Hand PlantSurah MaryamLabor PainBirth AnxietyBirth Satisfaction

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    VAS is used to measure perceived pain. It consists of a 10 cm (100 mm) line with one end labeled "no pain" and the other "worst possible pain." The participant marks a point on the line corresponding to the intensity of their pain. The distance in millimeters from "no pain" to the mark is measured and recorded as the pain score. Cline et al. (1992) reported that vertical orientation was better understood by patients. The scale was originally developed by Price et al. (1983). Eti-Aslan (1998) found that VAS was more sensitive in the evaluation of postoperative (acute) pain

    through study completion, an average of 1 year

  • Oxford Worry About Labour Scale (OWLS)

    Developed by Redshaw, Martin, Rowe, and Hockley (2009) to assess women's worries related to the childbirth process. The Turkish validity and reliability study was conducted by Erkal and Özentürk (2016). The scale consists of 10 items rated on a 4-point Likert scale: (1) Very worried, (2) Fairly worried, (3) Not very worried, (4) Not at all worried. Scores are calculated from the total (minimum = 10, maximum = 40). The scale has three subdimensions: Pain and Distress, Uncertainty Before Birth, and Interventions. The Cronbach's alpha reliability coefficient of the Turkish version was found to be 0.83 (Erkal Aksoy \& Özentürk, 2016). In this study, the Cronbach's alpha value of the questionnaire was found to be 0.75.

    Through study completion, an average of 1 year

  • Birth Satisfaction Scale-Revised (BSS-R)

    The original Birth Satisfaction Scale was developed by Martin and Fleming (2011) to assess women's satisfaction with childbirth. In 2013, Martin and Martin revised the scale by reducing the number of items, resulting in the Birth Satisfaction Scale-Revised (BSS-R). The BSS-R is a 10-item Likert-type scale rated as: Strongly agree (4 points), Agree (3 points), Neutral (2 points), Disagree (1 point), Strongly disagree (0 points). Items 2, 4, 7, and 8 are reverse-scored. The total score ranges from 0 to 40, with higher scores indicating greater satisfaction. The scale has three subdimensions: Quality of Care (communication, support from healthcare providers, and cleanliness of the delivery room), Women's Personal Attributes (sense of control and anxiety during childbirth), and Stress Experienced During Labor (perceived stress and duration of labor). The Cronbach's alpha reliability coefficient of the Turkish version was reported as 0.72 (Gökmen, 2017). In this study, the Cronbach's alpha

    through study completion, an average of 1 year

Study Arms (3)

Surah Maryam group

EXPERIMENTAL

Pregnants who came for birth were taught the Surah Maryam. They were monitored throughout the labor process, and in addition to routine midwifery care, the Surah Maryam was recited twice during labor to provide spiritual support.

Behavioral: Surah Maryam group

Virgin Mary's Hand Plant group

EXPERIMENTAL

By monitoring the labor throughout the process, in addition to routine midwifery care, the pregnant was provided with moral support by placing the Virgin Mary's Hand plant in water and watching the plant unfold, guiding her to the idea that the birth canal would also open in the same way.

Behavioral: Virgin Mary's Hand Plant Group

Control Group

NO INTERVENTION

Routine midwifery care was provided at birth

Interventions

Pregnant women who came for birth were taught Surah Maryam. They were monitored throughout the labor process, and in addition to routine midwifery care, Surah Maryam was played twice during labor to provide spiritual support.

Surah Maryam group

he pregnant woman was monitored throughout labor; in addition to routine midwifery care, she was given spiritual support by placing the Virgin Mary's Hand plant in water and watching the plant unfold, encouraging her to believe that the birth canal also opens in the same way.

Virgin Mary's Hand Plant group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being literate
  • Being open to communication
  • Being at term (37-40 weeks)
  • Having a single, live fetus
  • Having no pregnancy complications
  • Having no conditions preventing labor
  • Having 4-6 cm cervical dilation (early active phase)
  • Planning a vaginal birth
  • Not having a diagnosed psychiatric illness
  • Volunteering to participate in the study
  • Being in cephalic presentation
  • Being Muslim

You may not qualify if:

  • Being illiterate
  • Having a high-risk pregnancy
  • Having a planned cesarean section
  • Developing complications during labor
  • Using pain-reducing methods such as narcotic analgesics or sedatives
  • Having a diagnosed psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk Universty

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • WHO

    World Health Organization

    STUDY DIRECTOR
  • ICMJE ICMJE

    ICMJE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was conducted in a randomized controlled experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 16, 2025

Study Start

September 6, 2023

Primary Completion

September 7, 2024

Study Completion

August 20, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results of this study will be made available upon reasonable request. Data will be shared beginning , 6 months after publication and ending 5 years following article publication. Access will be granted to researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the study investigators. Data will be shared through \\\[specify repository or method of sharing\].

Shared Documents
STUDY PROTOCOL
Time Frame
Individual participant data will be available beginning 6 months after publication and ending 5 years\] following publication.
Access Criteria
Access to de-identified individual participant data will be granted to researchers with a methodologically sound proposal. Requests must include a clear research question and analysis plan. Approval will be required from the study's principal investigator before data are released.
More information

Locations