NCT05468658

Brief Summary

The aim of the study is to compare the births that took place in the Feng Shui Birth unit and those that took place in the standard delivery unit in terms of mother-infant health outcomes. The study will be carried out in a private clinic in Istanbul, between July and December 2022. In the study, which is planned as a controlled experimental study, 50 women who applied first and met the inclusion criteria of the study will be selected as the Control Group (B), and it is planned that these women will give birth using the normal routine delivery unit of the clinic. It is planned that the next 50 women will form the Experimental Group (A): and give birth in the birth environment designed according to the Feng Shui Philosophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

March 10, 2022

Last Update Submit

October 3, 2024

Conditions

Keywords

Feng ShuiBirthPhilosophyMidwifery careBirth environment

Outcome Measures

Primary Outcomes (10)

  • Women's pain rates-before

    H0= The women who give birth in a Feng Shui birthing unit will have lower pain rates than women who give birth in a routine birthing unit. H1= There is no difference between the rates of pain of a woman who gives birth in a Feng Shui delivery unit and the rates of pain a woman who gives birth in a routine delivery unit. The woman's pain, will be measured by the Visual Analog Scale (VAS). VAS is a symptom assessment tool where individuals mark on a horizontal/vertical bar that is 10 cm or 100mm. While the starting point of this tool shows no symptoms, the ending point shows the most severe state.

    Between 21:00 o'clock and 06:00 o'clock before birth

  • Women's stress rates-before

    H0=The women who give birth in the Feng Shui delivery unit will have lower rates of stress than the women who give birth in the routine delivery unit. H1= There is no difference between the stress rates of a woman who gives birth in a Feng Shui delivery unit and tthe stress rates of a woman who gives birth in a routine delivery unit. The woman's stress will be measured with salivary cortisol kits. Cortisol assesment; İt is planned to look at cortisol values in order to express the stress level of women with objective data. Saliva samples will be taken from pregnant women to evaluate cortisol levels. Saliva samples will be collected through Salivette® (Sample Collection Tube, Sarstedt, Nümbrecht, Germany) brand saliva sample collection material.

    Between 21:00 o'clock and 06:00 o'clock before birth

  • Women's fear of childbirth rates

    Ho=The women who give birth in the Feng Shui delivery unit will have lower rates of fear of childbirth than the women who give birth in the routine delivery unit. H1= There is no difference between the fear of childbirth rates of a woman who gives birth in a Feng Shui delivery unit and the fear of childbirth rates of a woman who gives birth in a routine delivery unit. Women's fear before childbirth will be measured by Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) version A scale. The W-DEQ version A is a 33-item scale. The answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. A high item total score indicates a high level of fear. * W-DEQ score ≤ 37 mild, * W-DEQ score = 38-65 moderate, * W-DEQ score = 66-84 severe, * W-DEQ score ≥ 85 indicates clinical level of fear.

    Between 21:00 o'clock and 06:00 o'clock before birth

  • Women's fear of childbirth rates

    H0=The women who give birth in the Feng Shui delivery unit will have lower rates of fear of childbirth than the women who give birth in the routine delivery unit. H1= There is no difference between the fear of childbirth rates of a woman who gives birth in a Feng Shui delivery unit and the fear of childbirth rates of a woman who gives birth in a routine delivery unit. Postpartum fears of women will be measured with Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) version B. In the measurement tool, there are a total of 33 questions including feelings and thoughts such as fear, confidence, feeling of loneliness, and happiness. The scale is one-dimensional. Scores from the scale range from 33 to 198. If the scores obtained from the scale are lower than 37, it means low-grade fear of childbirth, between 38-65 indicates moderate fear of childbirth, 66-84 indicates severe fear of childbirth, and above 85 indicates clinical-grade fear of childbirth (Uçar, 2013).

    2 hours after birth

  • Labor time

    H0=The labor period of the woman who give birth in the Feng Shui delivery unit will have shorter than the woman who give birth in the routine delivery unit. H1= There is no difference between the labor period of a woman who gives birth in a Feng Shui delivery unit and the labor period a woman who gives birth in a routine delivery unit.

    between 10-15 hours on average

  • The intervention (use of synthetic oxytocin, use of instrumental, resorting to episiotomy, urgent need for cesarean section)

    H0= The rate of intervention to women in the Feng Shui delivery unit will have lower than the rate of intervention to women in the routine delivery unit (use of synthetic oxytocin, use of instrumental, resorting to episiotomy, urgent need for cesarean section). H1= There is no difference between the rates of intervention of a woman who gives birth in a Feng Shui delivery unit and the rates of intervention a woman who gives birth in a routine delivery unit.

    between 10-15 hours on average

  • Women's concern rates-before

    H0=The women who give birth in the Feng Shui delivery unit will have lower rates of concern than the women who give birth in the routine delivery unit. H1= There is no difference between the rates of concern of a woman who gives birth in a Feng Shui delivery unit and the rates of concern a woman who gives birth in a routine delivery unit. The woman's concern will be measured by the Visual Analog Scale (VAS). VAS is a symptom assessment tool where individuals mark on a horizontal/vertical bar that is 10 cm or 100mm. While the starting point of this tool shows no symptoms, the ending point shows the most severe state.

    Between 21:00 o'clock and 06:00 o'clock before birth

  • Women's concern rates-after

    H0=The women who give birth in the Feng Shui delivery unit will have lower rates of concern than the women who give birth in the routine delivery unit. H1= There is no difference between the rates of concern of a woman who gives birth in a Feng Shui delivery unit and the rates of concern a woman who gives birth in a routine delivery unit. The woman's concern will be measured by the Visual Analog Scale (VAS). VAS is a symptom assessment tool where individuals mark on a horizontal/vertical bar that is 10 cm or 100mm. While the starting point of this tool shows no symptoms, the ending point shows the most severe state.

    2 hours after birth

  • Women's pain rates-after

    H0= The women who give birth in the Feng Shui delivery unit will have lower rates of pain than the women who give birth in the routine delivery unit. H1= There is no difference between the rates of pain of a woman who gives birth in a Feng Shui delivery unit and the rates of pain a woman who gives birth in a routine delivery unit. The woman's pain, will be measured by the Visual Analog Scale (VAS). VAS is a symptom assessment tool where individuals mark on a horizontal/vertical bar that is 10 cm or 100mm. While the starting point of this tool shows no symptoms, the ending point shows the most severe state.

    2 hours after birth

  • Women's stress rates-after

    The women who give birth in the Feng Shui delivery unit will have lower rates of stress than the women who give birth in the routine delivery unit. The woman's stress will be measured with salivary cortisol kits. Cortisol assessment; İt is planned to look at cortisol values in order to express the stress level of women with objective data. Saliva samples will be taken from pregnant women to evaluate cortisol levels. Saliva samples will be collected through Salivette® (Sample Collection Tube, Sarstedt, Nümbrecht, Germany) brand saliva sample collection material.

    2 hours after birth

Secondary Outcomes (4)

  • The satisfaction

    2 hours after birth

  • Breastfeeding proficiency rate

    2 hours after birth

  • Breastfeeding initiation time

    one minute after birth

  • APGAR score

    one minute after birth

Study Arms (2)

Experimental Group (A): Feng Shui Birth Unit

EXPERIMENTAL

1. The cabinets will be painted using salmon and pastel green. 2. It is planned to make designs specific to the philosophy of Feng Shui on the doors and walls of the birthing unit. 3. Live nature videos and sounds will be projected onto the wall. 4. Fabric curtains will be replaced with curtains designed according to the philosophy of Feng Shui. 5. Natural plants will be placed. 6. Lighting will be used. 7. Bed linen will be designed according to the Feng Shui. 8. Wooden bell will be used. 9. Turtle, elephant and Wu Lou objects will be placed. 10. The Bagua mirror will be placed. 11. Crystals will be placed. 12. Natural stones will be placed. 13. The fountain will be placed in the east compass direction of the unit. 14. Straw bamboo separator will be used.

Other: Designing the birthing unit according to the philosophy of Feng Shui

Control Group (B): Routine Birth Unit

NO INTERVENTION

The delivery unit of the institution consists of a small corridor, a labor room, a delivery room and a baby room. In the small corridor, there is a desk, document cabinets, vaccine cabinet and medicine cabinet for the midwife to work. The institution's routine delivery unit is equipped with standard medical devices and supplies. However, there are medical devices that are not used in the unit. White bed linens designed with the standard hospital logo are used in the unit. However, the curtains are plain cream, the walls are light blue, and the ceilings are white.

Interventions

1. The cabinets will be painted using salmon and pastel green. 2. It is planned to make designs specific to the philosophy of Feng Shui on the doors and walls of the birthing unit. 3. Live nature videos and sounds will be projected onto the wall. 4. Fabric curtains will be replaced with curtains designed according to the philosophy of Feng Shui. 5. Natural plants will be placed. 6. Lighting will be used. 7. Bed linen will be designed according to the Feng Shui. 8. Wooden bell will be used. 9. Turtle, elephant and Wu Lou objects will be placed. 10. The Bagua mirror will be placed. 11. Crystals will be placed. 12. Natural stones will be placed. 13. The fountain will be placed in the east compass direction of the unit. 14. Straw bamboo separator will be used.

Also known as: Unit design
Experimental Group (A): Feng Shui Birth Unit

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women;
  • No Turkish communication problem,
  • be at least 18 years old,
  • No history of risky pregnancy
  • Not having a chronic (Cardiovascular system diseases, Diabetes Mellitus, Hypertension, etc.) and mental (Major depression, Psychosis, etc.) disease,
  • Having nulliparous pregnant women who will give birth to a singleton baby in the head delivery position,
  • to 42 weeks of gestational weeks of gestation,
  • Pregnant women who are faced with cord entanglement, meconium amniotic fluid problems but decided to continue their vaginal delivery
  • To be able to meet the criteria for saliva sampling, Having stopped eating at least 1.5 hours ago, Stopped consuming beverages containing caffeine in the last 2 hours, Not doing any strenuous physical activity in the last 1 hour, Not consuming alcohol within 24 hours, Not brushing teeth in the last 2 hours and no bleeding in the gums

You may not qualify if:

  • Pregnant women who applied to the delivery unit between 21:00 and 06:00.
  • Having a Body Mass Index (BMI) below 18.5 kg/m2 and above 24.9 kg/m2 during the pregnancy period,
  • Newborn baby weighing less than 2.5 kg or over 4.5 kg,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Mediplus Medical Center

Turkey, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DystociaWounds and InjuriesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • ZULFIYYA NURALIYEVA, PhD

    Istinye University

    STUDY DIRECTOR
  • GULUMSER DOLGUN, PHD

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. in Midwifery in Istinye University

Study Record Dates

First Submitted

March 10, 2022

First Posted

July 21, 2022

Study Start

January 1, 2022

Primary Completion

May 1, 2022

Study Completion

December 30, 2022

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations