Clinical trial NCT04838340: Effect of Hypnobirthing Training on Fear, Pain, Satisfaction and, Birth Outcomes
Official title: Effect of Hypnobirthing Training on Fear, Pain, Satisfaction Related to Birth and, Birth Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Education
Pregnancy Related
Labor Pain
Keywords: Childbirth
Labor Pain
Fear of childbirth
Satisfaction
Prenatal education
Hypnobirthing
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Purpose: Hypnobirthing is childbirth education model. This model aims for women to have a painless, calm and more comfortable birth. In this study is aimed to determine the effect of Hypnobirthing training on fear of childbirth, birth pain, birth satisfaction and birth outcomes.

Materials and Methods: This randomized controlled experimental study was performed in Maternity Hospital (Bursa, Turkey) . The minimum required sample size to be included in the study will calculated with G\* power. The simple randomization method was use in the assignment of healthy and nulliparous pregnant women at 28-32 weeks of gestation to the groups. The assignment of the participants to the experimental group or control group was carried out with a computer-aided program. The nulliparous women was divided into two groups as the control group contained women who received the hospital's usual care, and the experimental group contained women who received the hypnobirthing training intervention. The fear of birth was measured with the Wijma Birth Expectancy/Experience Scale A and B (W-DEQ); labor pain was measured with Visual Analogue Scale (VAS); birth satisfaction was measured with Short Form of Birth Satisfaction Scale (BSS-R); birth outcomes will measure with postpartum Information form. The Statistical Package for the Social Sciences program (version 25.00) was use in data analysis.

Detailed description: Fear of childbirth and labor pain are big problem that needs to be resolved as a priority since this situation continues by starting the vicious cycle of fear-anxiety-pain during childbirth. The persistence of the cycle increases the fear and pain related to childbirth, and thus delivery may result in emergency cesarean or elective cesarean. According to the data of Economic Development and Cooperation (OECD), the cesarean section rate in Turkey is 53.1% and so higher than the recommended rate, even Turkey has the highest rate among the OECD countries . High cesarean rates are an important problem that negatively affects maternal and infant health and increase health expenditures and costs. Therefore, the pregnant women education programs aimed at lowering the rate of cesarean section are still important in Turkey as in other countries. While the childbirth education programs for pregnant women are not widely practiced in Turkey, the Turkish Ministry of Health (TMOH) started to provide childbirth preparation courses to reduce the rate of cesarean section in recent years. In the circular issued by the TMOH in 2018, it was determined that these programs should be managed by physicians, obstetrics nurses, and midwives. Nurses are actively involved in pregnancy training programs where different methods are applied in Turkey as well as all over the world. The most common training methods applied in other countries are Lamaze Method, Bradly Method, and Hypnobirthing.

Hypnobirthing is a childbirth preparation method that aims to prepare pregnant women for delivery mentally and physically and to give birth in a less painful, conscious, and fear-free way. This method was developed based on the fear-stress-pain cycle. The persistence of this cycle exacerbates stress and pain, prolongs the birth period, and negatively affects the success, way, preference, course, and satisfaction of the birth. Thus, the birth does not proceed properly and results in an emergency or elective cesarean section. Hypnobirthing can prepare women for childbirth to eliminate all these negativities.

Hypnobirthing training can be considered as a new technique for Turkey and therefore we conducted this study to determine its effects on the pain, fear, satisfaction related to childbirth and childbirth outcomes.

Eligibility criteria: Inclusion Criteria:

* Primiparas
* Ages between 18-42
* In gestational week 28-32
* Being literate in Turkish
* Pregnant with a single child
* Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)

Exclusion Criteria:

* High-risk pregnancy (on the basis of the criteria of the Ministry of Health)
* Attended other prenatal training sessions (pregnancy pilates and yoga)
* High-risk pregnancy

Primary outcomes:
measure: Preinterventional Scores on the W-DEQ-A (the minimum values:0, maximum:165)
timeFrame: When the control and experimental groups were Enrollment in the study
measure: The VAS scores of the experimental and control groups (the minimum values:0, maximum=10)
timeFrame: in the process of labor (the first stage of labor: latent, active and transitional phases )
measure: W-DEQ-B Scores (the minimum values:0, maximum:160)
timeFrame: within eight hours after birth
measure: The chilbirth scores of the experimental and control groups (questionnaire)
timeFrame: within eight hours after birth
measure: BSS-R scores of experimental and control groups (the minimum values:0, maximum:40) • Low level of satisfaction ˂13 points, • Medium satisfaction level 14-27 points, • High satisfaction level ≥28
timeFrame: within eight hours after birth
Secondary outcomes:
measure: Women and baby interaction
timeFrame: within eight hours after birth
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Gonca Buran
Study officials:
affiliation: Uludag Üniversity
name: Gonca Buran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adnan Menderes Üniversity
name: Hilmiye Aksu, Professor
role: STUDY_DIRECTOR
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