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临床试验/NCT05468658
NCT05468658已完成不适用

The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Women's pain rates-before

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnant women who applied to the delivery unit between 21:00 and 06:
  • 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,

结局指标

主要结局

Women's pain rates-before

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

ZULFIYYA NURALIYEVA, PhD

Assist. Prof. in Midwifery in Istinye University

Istinye University

研究点 (2)

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