Mental Health Issue Clinical Trial
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
Status | Recruiting |
Enrollment | 198 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Bosnia and Herzegovina | County Hospital 'Dr. fra Mihovil Sucic' | Livno |
Lead Sponsor | Collaborator |
---|---|
University of Mostar |
Bosnia and Herzegovina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delivery Mode | caesarean section or vaginal birth | up to 10 months | |
Secondary | 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. |
up to 10 months | |
Secondary | 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). |
up to 10 months | |
Secondary | 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. | up to 10 months | |
Secondary | 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. | up to 10 months |
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