Clinical trial NCT04104009: The Relation Between Midwifery Education and Listening to Classical Music With the Mode of Delivery
Official title: The Relation Between Midwifery Education of Pregnant Women and Listening to Classical Music With the Mode of Delivery, the Length of Breastfeeding and the Incidence of Psychic Symptoms: RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delivery Mode
Pain Score
Breastfeeding Rate
Mental Health Issue
Apgar Score
Keywords: midwifery
education
pregnancy
delivery mode
music therapy
breastfeeding
pain score
postnatal mental health
Apgar score
Lead sponsor: University of Mostar
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample is suitable, pregnant women in the second and third trimester of pregnancy who will give birth in a maternity ward County Hospital "Dr. Mihovil Sucic" Livno from February 2019 to the beginning of September 2019.

By randomization, the respondents will be divided into two groups:

1. Interventional group- a group where group education, breathing exercise and listening to classical music will be conducted.
2. Control group - a group who will spend the pregnancy without education, listening to classical music and breathing exercises.

Both groups are subject to inclusion and exclusion criteria.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The emotional and psychological well-being of women influence the perception and experience of pregnancy and childbirth. Pregnant women with a fear of childbirth are more likely to give birth by caesarean section. An increased risk of obstetric interventions such as planned and emergency caesarean section has been determined. Childbirth education is an intervention that has a major impact on maternity outcomes and birth experience

Detailed description: The emotional and psychological well-being of women significantly affects the perception and experience of pregnancy and childbirth. Pregnant women with a fear of childbirth are more likely to give birth by caesarean section. An increased risk of obstetric interventions such as planned and emergency caesarean section was also identified. Childbirth education is an intervention that has a great impact on birth outcomes and childbirth experiences.

A Cochrane systematic review found that the effects of antenatal education on childbirth and parenting are quite unknown. In a longitudinal cohort study, on a sample of 576 women, Bossano et al. investigated the impact of the vaginal birth method and the experience experienced on health after a decade. It was found that women with caesarean section were significantly more distressed than those who had delivered vaginally, and that the experience of childbirth remains in the memory even after a decade.

A randomized controlled study conducted in Australia by Fenwick et al. divided a sample of 339 pregnant women into a test and control group measured the impact of midwifery education on outcomes in childbirth, breastfeeding and the development of postpartum depression. Pregnant women of the interventional group received individual psychoeducation training by midwives in the second trimester of pregnancy. The control group did not undergo individual training. Finally, 184 female respondents with duly completed questionnaires were included in the analysis. In comparison with the control group, the caesarean section rate in the interventional was clinically but not statistically significantly lower (by 8%), and the need for an emergency caesarean section in the test group was less than 7%. There was no difference in the assessment of postpartum depression between the two groups. At 6 weeks postpartum, there was no statistically significant difference in the infant's diet between the two groups. In the interventional group, 83.5% were breastfed and 78.5% in the control group. It was concluded that the psychoeducation of pregnant women had the effect of reducing the overall rate of caesarean section. The impact of education on psychosocial health was found in a randomized controlled study called "Mindfulness - based program on the psychological health of pregnant women" in a sample of 104 women, divided into an interventional and control group. Pregnant women in the interventional group attended an eight-week program in groups between 13 and 26 weeks of gestation and used audio recordings at home, and had statistically significantly lower levels of stress and depression compared to the control group when measured at 36 weeks of gestation.

The use of deep inhalation and exhalation breathing exercises has proven effective in reducing the perception of pain in childbirth. A randomized clinical trial by Yuksel et al. in a sample of 250 pregnant women divided into test and control groups, the aim was to determine the effectiveness of the exercise on the perception of pain and the impact on the Apgar score of the infant after 1 minute. Pregnant women underwent a series of exercise training sessions and practiced during the first delivery phase to reduce stress and relaxation. There was a statistically significant difference in the lower perception of pain in the interventional group compared to the control group. A VAS scale of pain was used to assess pain. There was no statistically significant difference in the value of the Apgar score.

The therapeutic effects of listening to music on maternal and infant health have been proven in numerous studies. A lower incidence of anxiety and depression in women, a lower perception of pain during childbirth, a higher oxygen saturation in a newborn infant, and longer breastfeeding were found. A unique package with selected music has not been defined, but the choice is left to the creativity and knowledge of health professionals. A statistically significantly lower level of pain and anxiety at all measured time intervals was determined by a study in which a test group of 80 first-timers listened to music of their choice during childbirth compared to a control group who underwent childbirth without listening to music.

Based on the results of various studies, it can be concluded that the influence of antenatal education on the reduction of the rate of caesarean section in relation to vaginal delivery and the perception of pain during childbirth. Listening to classical music and breathing exercises significantly contribute to the reduction of labor pain, affecting the length of breastfeeding and the mental health of women in the maternity ward. An area requiring research is the fear of childbirth and its consequent impact on both maternity outcomes and the mental health of women in the ward.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Territory of Herceg-Bosna County
* Monitoring pregnancy in the competent Health Centers and private gynecological surgeries

Exclusion Criteria:

* Minor pregnant women
* Pregnant women in the first trimester of pregnancy
* Pregnant women after the 34th week of gestation
* Multiple pregnancies
* Pregnant women having a cesarean delivery in their anamnesis
* Pregnant women with psychiatric diagnosis
* Pregnancies at-risk
* Incomplete or illegally filled questionnaires
* Pregnant women who did not listen to classical music the agreed way
* Delivery of a stillborn baby

Primary outcomes:
measure: Delivery Mode
timeFrame: up to 10 months
Secondary outcomes:
measure: Apgar score
timeFrame: up to 10 months
measure: Pain score
timeFrame: up to 10 months
measure: Breastfeeding
timeFrame: up to 10 months
measure: Psychic symptoms
timeFrame: up to 10 months
Other outcomes:
Locations:
city: Livno
country: Bosnia and Herzegovina
facility: County Hospital 'Dr. fra Mihovil Sucic'
Study officials:
References: