Delivery ProblemNCT05468658
The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
A study testing Designing the birthing unit according to the philosophy of Feng Shui in people with Delivery Problem and Delivery Fear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Problem, Delivery Fear, Delivery; Injury
- What is being tested?
- Designing the birthing unit according to the philosophy of Feng Shui
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Mediplus Medical Center
Turkey, Istanbul, 34000
About this study
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.
Read the 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.
- Being tested
- Designing the birthing unit according to the philosophy of Feng Shui
- Keywords
- Feng Shui, Birth, Philosophy, Midwifery care, Birth environment
- Medical subject headings
- Dystocia, Wounds and Injuries, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designing the birthing unit according to the philosophy of Feng ShuiOther
Also called Unit design
- The cabinets will be painted using salmon and pastel green.
- It is planned to make designs specific to the philosophy of Feng Shui on the doors and walls of the birthing unit.
- Live nature videos and sounds will be projected onto the wall.
- Fabric curtains will be replaced with curtains designed according to the philosophy of Feng Shui.
- Natural plants will be placed.
- Lighting will be used.
- Bed linen will be designed according to the Feng Shui.
- Wooden bell will be used.
- Turtle, elephant and Wu Lou objects will be placed.
- The Bagua mirror will be placed.
- Crystals will be placed.
- Natural stones will be placed.
- The fountain will be placed in the east compass direction of the unit.
- Straw bamboo separator will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 hours after birth
Secondary outcomes (4)
The satisfaction
H0=The satisfaction rate of the woman who give birth in the Feng Shui delivery unit will higher than the woman who give birth in the routine delivery unit.
H1= There is no difference between the the satisfaction rate of a woman who gives birth in a Feng Shui delivery unit and the satisfaction rate the a woman who gives birth in a routine delivery unit.
Birth satisfaction of women at stage 4 of labor will be measured with the Birth Satisfaction Scale-Revised (BSS-R).
The scale consists of 10 items and 3 sub-dimensions. The total raw score ranges from 0-40. As the total score obtained from the scale increases, the satisfaction level of women with the care they receive at the hospital increases. In this study, scale cut-off scores were calculated by dividing the total score into three equal parts: - (1) low satisfaction <13 points, (2) moderate satisfaction 14-27 points, (3) high satisfaction ≥28 points.
Measured: 2 hours after birth
Breastfeeding proficiency rate
H0=The postpartum breastfeeding adequacy ratio scores will higher for a woman who gives birth in a Feng Shui delivery unit compare to a woman who gives birth in a routine delivery unit.
H1= There is no difference between the breastfeeding proficiency rate of a woman who gives birth in a Feng Shui delivery unit and breastfeeding proficiency rate the a woman who gives birth in a routine delivery unit.
Breastfeeding proficiency rate will be measured with the Bristol Breastfeeding Scale. The tool was developed to measure frequently encountered postpartum breastfeeding difficulties and its validity has been approved.
The scale is a Likert-type scale comprising the 4 items of "positioning," "holding," "sucking" and "swallowing." Each item is scored between 0- 2 points. The lowest possible score on the scale is 0, the highest is 8. Lower scores indicate that the breastfeeding is not successful, the higher scores signify successful breastfeeding.
Measured: 2 hours after birth
Breastfeeding initiation time
H0=Breastfeeding initiation time will shorter for a woman who give birth in a Feng Shui delivery unit compare to a woman who give birth in a routine delivery unit.
H1= There is no difference between the breastfeeding initiation time of a woman who gives birth in a Feng Shui delivery unit and breastfeeding initiation time the a woman who gives birth in a routine delivery unit.
Measured: one minute after birth
APGAR score
H0=APGAR scores will higher for a woman who give birth in a Feng Shui delivery unit compare to a woman who give birth in a routine delivery unit.
H1= There is no difference between the APGAR scores of a woman who gave birth in a Feng Shui delivery unit and the APGAR scores of a woman who gave birth in a routine delivery unit.
Measured: one minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Jan 2022
- Primary completion1 May 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ProblemStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZULFIYYA NURALIYEVA, PhD, Istinye University
- Investigators
- ZULFIYYA NURALIYEVA, PhD, Study director, Istinye UniversityGULUMSER DOLGUN, PHD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468658
- Sponsor's protocol ID
- IstanbulUC-1
- Status last verified
- Oct 2024
- First submitted
- 10 Mar 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health
- ClinicalTrials.gov ID
- NCT05468658
- Acronym / sponsor ID
- IstanbulUC-1
- Keywords
- Feng Shui, Birth, Philosophy, Midwifery care, Birth environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (A): Feng Shui Birth Unit | Experimental | Other: Designing the birthing unit according to the philosophy of Feng Shui1. 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Designing the birthing unit according to the philosophy of Feng ShuiAlso: Unit design1. 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 | Experimental Group (A): Feng Shui Birth Unit |
Primary outcome
Women's pain rates-before
Time frame: Between 21:00 o'clock and 06:00 o'clock before birth
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.
Women's stress rates-before
Time frame: Between 21:00 o'clock and 06:00 o'clock before birth
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.
Women's fear of childbirth rates
Time frame: Between 21:00 o'clock and 06:00 o'clock before birth
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.
Women's fear of childbirth rates
Time frame: 2 hours after birth
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).
Labor time
Time frame: between 10-15 hours on average
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.
The intervention (use of synthetic oxytocin, use of instrumental, resorting to episiotomy, urgent need for cesarean section)
Time frame: between 10-15 hours on average
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.
Women's concern rates-before
Time frame: Between 21:00 o'clock and 06:00 o'clock before birth
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.
Women's concern rates-after
Time frame: 2 hours after birth
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.
Women's pain rates-after
Time frame: 2 hours after birth
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.
Women's stress rates-after
Time frame: 2 hours after birth
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.
4 secondary outcomes
The satisfaction
Time frame: 2 hours after birth
Breastfeeding proficiency rate
Time frame: 2 hours after birth
Breastfeeding initiation time
Time frame: one minute after birth
APGAR score
Time frame: one minute after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZULFIYYA NURALIYEVA, PhD study director
Istinye University
GULUMSER DOLGUN, PHD study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Designing the birthing unit according to the philosophy of Feng Shui in people with Delivery Problem and Delivery Fear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's pain rates-before (time frame: Between 21:00 o'clock and 06:00 o'clock before birth). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.