Clinical trial NCT05115071: Online Childbirth Preparation Education in Covid-19 Pandemic
Official title: The Effect of Online Childbirth Preparation Education in Pregnancy on Worries and Fear of Birth, Preparation for Birth, and Well-being of Self and Baby in the Covid 19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
COVID-19
Fear of Childbirth
Keywords: online childbirth preparation
fear of childbirth
worries on birth
preparation for birth
well-being of self and baby
Covid 19 pandemic
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind pre-post test randomized controlled design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Today, pregnancy and childbirth are important life events that involve many difficulties and changes that must be overcome for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often cause pregnant women to experience anxiety about the baby's health and their own health, and to create new stressful situations. Adding the pandemic conditions to this situation further complicates the process and it is seen that the fears of women towards the birth and postpartum period will increase even more. Childbirth preparation classes reduce the fear and anxiety of women and create a positive perception of birth. For this reason, it is more important to give birth preparation education to women during in pregnancy during the pandemic period. However, it is not possible to give face-to-face birth preparation education to women in this process. For this reason, the aim of this study is to examine the effect of online childbirth preparation education in pregnancy on worries and fear of birth, preparation for birth, and well-being of self and baby in the Covid 19 pandemic.

The research is a pre-post test randomized controlled experimental study. The block randomization method will be used. The universe of the research will consist of women who applied to Pamukkale University Research and Application Hospital pregnant outpatient clinic, and have a healthy pregnancy at 24-34 weeks of gestation. The education will be done online. The sample size was calculated in the G\*power statistics program using the data of a study in which the childbirth preparation education intervention was previously performed (α =0.05, d=1.05). Accordingly, it was found that 16 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 36 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.


Eligibility criteria: Inclusion Criteria:

* Be over 18 years old
* Volunteering to participate in research
* Be at 24-34 weeks of gestation
* Be nulliparous
* Not having a high risk pregnancy
* Be able to read and write Turkish
* Be able to fill out an online survey form
* Planning to have a normal spontaneous vaginal delivery

Exclusion Criteria:

* Be under the age of 18
* Not completing eight hours of childbirth preparation education
* Having a mental disorder that prevents answering survey questions
* Having a psychiatric illness
* Be able not use Microsoft Teams app

Primary outcomes:
measure: Oxford Worries on Labour Scale (OWLS)
timeFrame: Change from baseline Oxford Worries on Labour score at 2 weeks
measure: Prenatal Self Evaluation Questionnaire (PSEQ)-Preparation for labor subscale
timeFrame: Change from baseline Preparation for Labor score at 2 weeks
measure: Prenatal Self Evaluation Questionnaire (PSEQ)-Well-being of self and baby subscale
timeFrame: Change from baseline Well-being of Self and Baby score at 2 weeks
measure: Fear of Birth Scale (FOBS)
timeFrame: Change from baseline Fear of Birth score at 2 weeks
measure: The Fear of COVID-19 Scale (FCV-19S)
timeFrame: Change from baseline Fear of Covid-19 score at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: