Delivery ModeNCT04104009
The Relation Between Midwifery Education and Listening to Classical Music With the Mode of Delivery
A study testing Education and No education in people with Delivery Mode and Pain Score, run by University of Mostar at 1 site in Bosnia and Herzegovina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Mode, Pain Score, Breastfeeding Rate
- What is being tested?
- Education and No education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 1 Jan 2019to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women
- Territory of Herceg-Bosna County
- Monitoring pregnancy in the competent Health Centers and private gynecological surgeries
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
County Hospital 'Dr. fra Mihovil Sucic'
Livno, 80101
Roberta Perkovic, master, +38763414361, roberta.perkovic@fzs.sum.ba
About this study
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
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
Read the 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.
- Conditions
- Delivery Mode, Pain Score, Breastfeeding Rate, Mental Health Issue, Apgar Score
- Being tested
- Education, No education
- Keywords
- midwifery, education, pregnancy, delivery mode, music therapy, breastfeeding, pain score, postnatal mental health, Apgar score
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
No educationOther
In the control group there will be no education, no breathing exercises and no listening to classical music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education |
| Control group | Active comparator | In the control group there will not be any group training. Receives: Other: No education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery Mode
caesarean section or vaginal birth
Measured: up to 10 months
Secondary outcomes (4)
Apgar score
The Apgar score is a test given to newborns soon after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score:
- Appearance (skin color)
- Pulse (heart rate)
- Grimace response (reflexes)
- Activity (muscle tone)
- Respiration (breathing rate and effort) Scores are between 10 and 0. The test is given in the first and fifth minute. A baby who scores a 7 or above on the test is considered in good health. Perfectly healthy babies sometimes have a lower-than-usual score, especially in the first few minutes after birth.
Scores of 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
Measured: up to 10 months
Pain score
A Visual Analogue Scale (VAS) is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Recall period for items varies, but most commonly respondents are asked to report "current" pain intensity or pain intensity "in the last 24 hours.
Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post- surgical patients have been recommended: no pain (0-0,4 cm), mild pain(0,5-4,4 cm), moderate pain (4,5-7,4 cm), and severe pain (7,5-10 cm).
Measured: up to 10 months
Breastfeeding
Establishment of breastfeeding 6 weeks after maternity discharge. It is measured by a self-administered breastfeeding questionnaire. The questionnaire was created for research purposes. It contains 5 questions. The questionnaire has been sent to the patients six weeks after delivery. The purpose of the questionnaire is to claim answers about modes of feeding of newborns after six weeks (exclusive/not exclusive breastfeeding), to find out about support of women after delivery, to find reason of giving up on exclusive breastfeeding (if they gave up), to determine who had the gratest influence in their attitude about breastfeeding.
Measured: up to 10 months
Psychic symptoms
The Symptom Checklist-90-R (SCL-90-R) is a relatively brief self-report psychometric instrument (questionnaire) published by the Clinical Assessment division of the Pearson Assessment \& Information group. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It consists of 90 items and takes 12-15 minutes to administer, yielding nine scores along primary symptom dimensions and three scores among global distress indices. The primary symptom dimensions that are assessed are somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and a category of "additional items" which helps clinicians assess other aspect of the clients symptoms (e.g. item 19, "poor appetite"). The three indices are global wellness index, hardiness, and symptom free. It is one of the most widely used measures of psychological distress in clinical practice and research.
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2019
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ModeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mostar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Perkovic, University of Mostar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104009
- Sponsor's protocol ID
- UMostar
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04104009
- Acronym / sponsor ID
- UMostar
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University of MostarUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: EducationIn 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. |
| Control group | Active comparator | Other: No educationIn the control group there will not be any group training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women
- Territory of Herceg-Bosna County
- Monitoring pregnancy in the competent Health Centers and private gynecological surgeries
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationFollowing 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. | Other | Interventional group |
| No educationIn the control group there will be no education, no breathing exercises and no listening to classical music. | Other | Control group |
Primary outcome
Delivery Mode
Time frame: up to 10 months
caesarean section or vaginal birth
4 secondary outcomes
Apgar score
Time frame: up to 10 months
Pain score
Time frame: up to 10 months
Breastfeeding
Time frame: up to 10 months
Psychic symptoms
Time frame: up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Delivery Mode
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Prenatal Yoga Intervention in Pregnant Women
Pregnant Women, Prenatal Yoga
RecruitingObservational study
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
Healthy Newborn Infants
Not yet recruiting
Two Sessions of Coach-Delivered Core Transformation for Distress and Well-Being
Psychological Distress, Psychological Well-being
Active, not recruitingObservational study
Thailand Birth and Infant Outcomes Study
Outcome Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and No education in people with Delivery Mode and Pain Score, run by University of Mostar at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Perkovic, master (+38763414361, roberta.perkovic@fzs.sum.ba), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery Mode (time frame: up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.