Clinical trial NCT05468658: The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
Official title: The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery Problem
Delivery Fear
Delivery; Injury
Birth; Prolonged
Birth Disorder
Keywords: Feng Shui
Birth
Philosophy
Midwifery care
Birth environment
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This study is based on the hypothesis that the birth environment requires greater attention to ameliorate existing challenges in modern obstetric practice. The main focus is on the negative experiences that result from increased intervention during childbirth and the accompanying fear, anxiety, pain and stress. In order to reduce these emerging problems, it is planned to design the maternity unit based on the Feng Shui philosophy, inspired by the information obtained from the evidence-based health service design advocating bringing nature to the hospital.

Studies conducted abroad on what kind of birth environment women want and evidence-based guidelines. However, there is a need for such studies to be conducted in Turkey and for the creation of evidence-based guidelines by taking cultural characteristics into account. In line with this study, it is thought that planning and implementing new and positive birth environments with a multidisciplinary approach by architects, designers and health professionals will contribute positively to mother and baby health.

The dissemination of evidence-based good practices in obstetrics services to include all women giving birth is necessary in terms of the principle of quality service and equality. However, with this study, it is emphasized that the birth environment is not only limited to spatial arrangement, but is a matter of philosophy.

In this context, it is aimed to compare the births in the Feng Shui delivery unit with the ones that take place in the routine birth unit, with its design and decoration that will minimize the rate of anxiety, fear, pain, stress, emergency cesarean section, synthetic oxytocin and instrumental need, and increase the rates of maternal satisfaction and breastfeeding proficiency.

Eligibility criteria: Inclusion Criteria:

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,
* 37 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

Exclusion Criteria:

* 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,

Primary outcomes:
measure: Women's pain rates-before
timeFrame: Between 21:00 o'clock and 06:00 o'clock before birth
measure: Women's stress rates-before
timeFrame: Between 21:00 o'clock and 06:00 o'clock before birth
measure: Women's fear of childbirth rates
timeFrame: Between 21:00 o'clock and 06:00 o'clock before birth
measure: Women's fear of childbirth rates
timeFrame: 2 hours after birth
measure: Labor time
timeFrame: between 10-15 hours on average
measure: The intervention (use of synthetic oxytocin, use of instrumental, resorting to episiotomy, urgent need for cesarean section)
timeFrame: between 10-15 hours on average
measure: Women's concern rates-before
timeFrame: Between 21:00 o'clock and 06:00 o'clock before birth
measure: Women's concern rates-after
timeFrame: 2 hours after birth
measure: Women's pain rates-after
timeFrame: 2 hours after birth
measure: Women's stress rates-after
timeFrame: 2 hours after birth
Secondary outcomes:
measure: The satisfaction
timeFrame: 2 hours after birth
measure: Breastfeeding proficiency rate
timeFrame: 2 hours after birth
measure: Breastfeeding initiation time
timeFrame: one minute after birth
measure: APGAR score
timeFrame: one minute after birth
Other outcomes:
Locations:
city: Turkey
country: Turkey
facility: Private Mediplus Medical Center
state: Istanbul
Study officials:
affiliation: Istinye University
name: ZULFIYYA NURALIYEVA, PhD
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: GULUMSER DOLGUN, PHD
role: STUDY_CHAIR
References: