Clinical trial NCT04740762: The Effect of Individual Counselling Program on Fear of Childbirth
Official title: The Effectiveness of an Individual Counselling Program in Coping With Fear of Childbirth: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Pregnancy Related
Keywords: Prenatal care
Fear
Childbirth
Counseling
Midwifery
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Primary purpose: PREVENTION

Brief summary: A randomized control trial was made to developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

Detailed description: Fear of childbirth is a common problem among women and one that affects their health and welfare before and during pregnancy and in the postpartum period. The problem can lead to adverse pregnancy outcomes and also cause a woman to experience psychological issues. Fear of childbirth can also influence the determination of the mode of delivery and can amount to a rise in cesarean rates.

The healthcare provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or exacerbate childbirth fears. The most significant midwifery intervention that can be used to diminish the fear of childbirth is counseling. There is a need to develop and test individual counseling models that require the basic training skills that midwives can use as part of their routine care to address women's fears and expectations about childbirth. The individual counseling program developed in this context may be an easy-to-implement and cost-effective method to use.

This study was conducted for the purposes of developing an individual counseling program to help women cope with their fear of childbirth and testing the program for effectiveness.

It was tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of fear of childbirth, childbirth self-efficacy and state anxiety scores and childbirth outcomes (duration of labor, mode of delivery, elective and emergency cesarean rates, postpartum hypertension and need for a blood transfusion, the admittance of the newborn into the intensive care unit, preferences for future births and duration of stay in hospital).

Eligibility criteria: Inclusion Criteria:

* Primiparas
* Ages between 18-35
* Lived in Aydın
* In gestational week 28-30,
* Pregnant with a single child
* Minimum a primary school graduate (since the questionnaires would be filled out by self-reporting)
* In a low-risk pregnancy (on the basis of the criteria of the Ministry of Health),
* Willing to divulge their own or their husband's telephone numbers,

Exclusion Criteria:

* High-risk pregnancy who had psychological and mental health problems
* History of infertility
* Speech and hearing disabilities
* Substance or narcotics users

Primary outcomes:
measure: Fear of childbirth before intervention
timeFrame: 28-30 gestational weeks
measure: Fear of childbirth after intervention
timeFrame: 36-38 gestational weeks
measure: Fear of childbirth after birth
timeFrame: 12th-24th hour after the birth
measure: Childbirth Self-Efficacy before intervention
timeFrame: 28-30 gestational weeks
measure: Childbirth Self-Efficacy after intervention
timeFrame: 36-38 gestational weeks
measure: State Anxiety before intervention
timeFrame: 28-30 gestational weeks
measure: State Anxiety after intervention
timeFrame: 36-38 gestational weeks
measure: Duration of labor
timeFrame: 12th-24th hour after the birth
measure: Mode of Delivery
timeFrame: 12th-24th hour after the birth
measure: Elective and Emergency Cesarean Rates
timeFrame: 12th-24th hour after the birth
Secondary outcomes:
measure: Postpartum hypertension
timeFrame: 12th-24th hour after the birth
measure: Need for a blood transfusion
timeFrame: 12th-24th hour after the birth
measure: Admittance of the Newborn into the Intensive Care Unit
timeFrame: 12th-24th hour after the birth
measure: Preferences for Future Births
timeFrame: 12th-24th hour after the birth
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Turkey
state: Efeler
Study officials:
affiliation: Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
name: Gizem Öztürk, PhD
role: STUDY_CHAIR
References: