Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
- Conditions
- Maternal and Child Health OutcomesPregnancyMental Health
- Registration Number
- NCT07003048
- Lead Sponsor
- Clara Angela Foundation
- Brief Summary
This prospective study was preceded by an extensive feasibility study between 2021-2024. Thereby, pregnant women were exposed to live music and a variety of creative workshops such as vibration, modelling, creative writing, singing, dancing and active listening to concerts from 12 gestational weeks onwards up to delivery at two-week intervals. The investigators detected significant changes in affection detected by the PANAS-test, cortisol from buccal swabs, and maternal heart rate variability before and after the interventions. Similarly, the investigators could detect significant changes by validated questionnaires for maternal stress (PSS), maternal anxiety detected by STAI and the risk of depression detected by EPDS.
Therefore, from January 2025 onwards, the investigators integrated "only" concerts and workshops in singing and dancing as relevant interventions. In a comparative prospective study, the investigators now want to study, whether the effects of life participation within the Philharmonic building at approximately 2-week intervals would have the same short-term and medium-term effects as in pregnant women following the same digitalized interventions from home (DIGITALIZED versus LIVE INTERVENTION = DL). This would offer the chance to reach pregnant women in regions with high needs for interventions to reduce stress during pregnancy, such as in areas involved in wars, environmental disasters or other stressful life conditions.
The primary outcomes are short-term differences in affection measured immediately before and after all interventions, and differences in cortisol from buccal swabs, measured twice after concerts during pregnancy.
The secondary outcomes are the medium-term changes throughout pregnancy in validated questionnaires of PSS, STAI and EPDS, the perinatal and neonatal outcomes such as development and tempoerament of the infants by validated questionnaires AGES and STAGES 6 and 12 months after birth and a follow-up of infants after two years by the Parca-R. questionnaire. In addition the gold MSI will be evaluated in both groups to test the affinity to music as well as the correlation with linguistic development by EEG of the newborns.
Hypothesis: Both interventions lead to a rapid reduction in the psychological and physiological stress of pregnant women. The effects may be more pronounced with live music.
A total of 128 women will be assigned to one of two groups. Taking into account a drop-out rate of 5-10% during the course of the study, the investigators expect to have complete data from 116 women (approximately 58 per group) to evaluate the effectiveness of the intervention.
Based on our previous studies on the reduction of psychological stress and cortisol levels by concert interventions showing significant changes in mean cortisol levels, the effect sizes of the intervention on site are estimated to be moderate: Assuming a moderate effect size (f = 0.25) and a β/α ratio = 4, N = 58 women per group and using 5 repeated measures are needed to detect differences between the two groups.
Due to the fact that the life concerts and workshops had to be prepared by a professional team, the investigators could not perform a randomized controlled trial as orginally intended but hat to form the groups consecutively by recruitment from outpatient units in berlin and environment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- Pregnant women from 10 gestational weeks onwards not younger than 18 years and not older than 50 years
- no severe medical or mental disease
- capable to understand german or English language
- Pregnant women outside the above declared inclusion criteria
- more than 20 gestational weeks at recruitment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Short-term differences before and after musical interventions Five minutes before and after the workshop or concert starts and ends. In total six concerts and five workshops take place. Short-term differences in affection measured immediately before and after all interventions by the PANAS Test (Positive and Negative Affect Schedule). Each time the same six factors are asked in the PANAS. The minimum score is 3 (low affect),the maximum score is 15 (high affect).
Short-term differences before and after musical interventions (Cortisol) 1. At the second concert (gestational age between 22 and 28 weeks), 2. at the fifth concert (gestational age between 30 and 36 weeks). Not more than three minutes before and after the second and fifth concert. Short-term differences in affection measured immediately before and after all interventions by the differences in cortisol level from buccal swabs, measured twice before and after concerts during pregnancy. In the beginning and at the end of the study.
- Secondary Outcome Measures
Name Time Method Medium-term outcome measures (PSS) 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks. Changes in maternal mental health throughout pregnancy of validated psychological questionnaires such as PSS (Perceived Stress Scale) from the start of recruitment up to delivery. Minimum score is zero (0) and shows low stress. The maximum score is forty (40) considered as high perceived stress.
Medium-term outcome measures (STAI) 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks. Changes in maternal mental health throughout pregnancy of validated psychological questionnaires such as STAI (State Trait Anxiety Inventory) from the start of recruitment up to delivery. The minimal score result is 10, the maximal score result is 80 for each of the two parts (State and Trait).
Medium-term outcome measures (EPDS) 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks Changes in maternal mental health throughout pregnancy of validated psychological questionnaires such as EPDS (Edinburgh Postnatal Depression Scale) from the start of recruitment up to delivery. The minimal score result is zero (0), thereby 0-9 points signifies low risk of depression. The maximum score result is thirty (30), with more or equal thirteen (13) points demonstrating a high risk for depression. Ten (10) to twelve (12) signifies moderate risk for depression.
Medium-term outcome measures 1. Gestational age between 12 and 18 weeks, 2. at the end of pregnancy, when women are admitted at the labor room. Since we cannot predict in advance the gestational age at delivery, due to pragmatic reasons, we cannot be more precise. Changes in maternal mental health throughout pregnancy by the concentration of cortisol within maternal hair from the start of recruitment up to delivery.
Long-term outcome measures (AGES and STAGES) 6 and 12 months after birth The perinatal and neonatal outcomes as well as follow-up of the infants by AGES and STAGES after 6 and 12 months. The Ages and Stages Questionnaire (ASQ) is a general developmental screening tool that examines developmental challenges at specific ages. Minimum score result is zero (0) and maximum score result is 300. Characterizing the least and the optimal stages of development.
Long-term outcome measures (PARCA-R) 24 months after birth The Parca-R asked at two years after delivery. PARCA-R stands for Parent Report of Children's Abilities-Revised. It is a parent completed questionnaire that can be used to assess children's cognitive and language development at 24 months of age. The minimal value of the PARCA-R score results for a) cognitive and b) language development is zero (0). The maximum of a) is 34 and for b) 50. Thus the minimal value of the total score is zeo (0) and the maximal 84, characterizing the least and the optimal stages of cognitive and verbal development. Within the investigators plan to compare means with ranges to the standards given in the original publication of Johnson et al. (Lancet Child Adolesc Health 2019) and also compare the results of the Live and Digital Group.
Trial Locations
- Locations (1)
Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics
🇩🇪Berlin, Germany