The Relation Between Midwifery Education and Listening to Classical Music With the Mode of Delivery

NCT04104009 | Unknown

• 1 other identifier: UMostar
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Delivery Mode

  caesarean section or vaginal birth

  up to 10 months

Secondary Outcomes (4)

• Apgar score

  up to 10 months

• Pain score

  up to 10 months

• Breastfeeding

  up to 10 months

• Psychic symptoms

  up to 10 months

Study Arms (2)

Interventional group

EXPERIMENTAL

In the exam group there will be group training for four meetings of one hour each. After completing the training program with the test group, a break of 5 weeks will follow, during which a new test and control group will be formed. The procedure will be carried out until the estimated sample size (99 subjects per group) is met.

Other: Education

Control group

ACTIVE COMPARATOR

In the control group there will not be any group training.

Other: No education

Interventions

Education OTHER

Following the randomization process, group education of pregnant women will be conducted through four one-hour meetings. Education program: teaching about the basics of childbirth physiology, visit to the maternity ward with the aim of reducing the fear of childbirth, applying the deep inhale and exhale exercise in the first birth stage, applying the classical music listening technique that will continue until the end of pregnancy daily (in the evenings before bedtime) (for 15 minutes), teaching and applying techniques for successful breastfeeding, maternal and infant health care after delivery. The training program will be implemented so that after 4 workshops a 5-week break will be taken. At the end of the program, the educator arranges with the respondents a weekly telephone check (for the sake of communication quality) to inform them of adherence to the agreed classical music listening.Pregnant women who do not meet expectations will be excluded from the study.

Interventional group

No education OTHER

In the control group there will be no education, no breathing exercises and no listening to classical music.

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mostar: lead

Study Sites (1)

County Hospital 'Dr. fra Mihovil Sucic'

Livno, 80101, Bosnia and Herzegovina

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Roberta Perkovic, master

CONTACT

+38763414361; roberta.perkovic@fzs.sum.ba

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head nurse of the department of women's diseases and childbirth

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)