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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live music intervention | Experimental | Singing and dancing in small groups combined with live concerts througout pregnancy |
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| Digital music intervention | Active Comparator | Digitalized version of singing and dancing workshops combined with recorded concerts offered to women at home throughout pregnancy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building | Behavioral | Pregnant women are invited from 12 gestational weeks onwards to participate in active and passive interventions following a protocol derived from our feasibility study. The following interventions take place: LIVE GROUP
DIGITAL GROUP The described interventions are all digitalized with interviews encouraging the second group to participate from home. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term differences before and after musical interventions | 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). | Five minutes before and after the workshop or concert starts and ends. In total six concerts and five workshops take place. |
| Short-term differences before and after musical interventions (Cortisol) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Medium-term outcome measures (PSS) | 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. | 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Music performance and development of linguistic skills | Goldsmiths musical sophistication index. The minimal score result is 31, representing poor integration of music at home and maximal score result is 266, representing optimal integration of music in every category. | 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks |
Inclusion Criteria:
Exclusion Criteria:
Only pregnant women from 12 gestational weeks onwards up to birth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Birgit Arabin, MD, PhD | Contact | +4915150470484 | bine.clara.angela@gmail.com | |
| Uwe Wiards | Contact | uwe@wiards.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics | Recruiting | Berlin | State of Berlin | D 14193 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28011436 | Background | Mannel C, Schaadt G, Illner FK, van der Meer E, Friederici AD. Phonological abilities in literacy-impaired children: Brain potentials reveal deficient phoneme discrimination, but intact prosodic processing. Dev Cogn Neurosci. 2017 Feb;23:14-25. doi: 10.1016/j.dcn.2016.11.007. Epub 2016 Nov 27. | |
| 32911996 | Background |
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We promied to evaluate all data following the german law of data protection and to handle the data anonomously.
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|
| Medium-term outcome measures (STAI) | 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). | 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks. |
| Medium-term outcome measures (EPDS) | 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. | 1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks |
| Medium-term outcome measures | Changes in maternal mental health throughout pregnancy by the concentration of cortisol within maternal hair from the start of recruitment up to delivery. | 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. |
| Long-term outcome measures (AGES and STAGES) | 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. | 6 and 12 months after birth |
| Long-term outcome measures (PARCA-R) | 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. | 24 months after birth |
| Placental and telomere data from umbilical cord blood a term | EEG (electroencephalogram) of newborns after 3-6 months. Thereby validated questionnaires and, optionally, an EEG device are used, with which the children's brain waves are recorded using non-invasive electrodes that make contact with the skin via a warm gel and are fixed in place with a cap (approx. 5 min resting EEG without acoustic stimulation, approx. 10 min EEG when listening to syllable sequences). The meaning of the tracings with respect of later language development has been established by our group before . More specifically, we shall analyze only brain potentials within event-related EEG-tracings, such as mismatch negativity (MMN). Not according to the frequency spectre such as alpha, beta etc. characteristics. | Up to 6 months after birth |
| Placental and telomere data from umbilical cord blood a term | Telomere length (TL) of the newborns determined at leucocytes in the umbilical blood at birth. Thereby DNA is isolated from whole blood. Leukocyte TL is the most commonly used measure of TL in human epidemiological studies, and it has been postulated that TL dynamics in leukocytes mirror those of the entire hematopoietic stem cell population, the original pool of which is formed early in gestation and serves as the progenitor for cells in all blood lineages. Relative TL is measured by quantitative polymerase chain reaction (qPCR), expressed as the ratio of telomere to single-copy gene abundance (T/S ratio), as previously described. | Directly after birth |
| Placental and telomere data from umbilical cord blood a term | Detection of the human placental11β-HSD2 to determine fetal stress during pregnancy. Placental 11β-HSD2 protein levels are quantified by Western blotting. The polyclonal sheep anti-human 11β-HSD2 antibody (LOT 318564, The Binding Site Group Ltd, Birmingham, UK) is used and tested beforehand in immunohisto-chemistry on 5 μm paraffin embedded placental sections. The blots are incubated overnight with the 11β-HSD2 antibody at a dilution of 1:1000 in 5% skim milk powder and analyzed on the next day. Each blot is repeated at least three times and included an internal control sample that controlled for inter-blotvariability. Protein results are expressed as ratio of 11β- HSD2, to β-Actin (1:80000, LOT GR67149-2, Abcam plc, Cambridge, UK) and expressed as relative optical density units (ROD). | Up to 6 months after birth |
| Verner G, Epel E, Lahti-Pulkkinen M, Kajantie E, Buss C, Lin J, Blackburn E, Raikkonen K, Wadhwa PD, Entringer S. Maternal Psychological Resilience During Pregnancy and Newborn Telomere Length: A Prospective Study. Am J Psychiatry. 2021 Feb 1;178(2):183-192. doi: 10.1176/appi.ajp.2020.19101003. Epub 2020 Sep 11. |
| 28706188 | Background | Faraji J, Soltanpour N, Lotfi H, Moeeini R, Moharreri AR, Roudaki S, Hosseini SA, Olson DM, Abdollahi AA, Soltanpour N, Mohajerani MH, Metz GAS. Lack of Social Support Raises Stress Vulnerability in Rats with a History of Ancestral Stress. Sci Rep. 2017 Jul 13;7(1):5277. doi: 10.1038/s41598-017-05440-8. |
| 31995213 | Background | Wu Y, Lu YC, Jacobs M, Pradhan S, Kapse K, Zhao L, Niforatos-Andescavage N, Vezina G, du Plessis AJ, Limperopoulos C. Association of Prenatal Maternal Psychological Distress With Fetal Brain Growth, Metabolism, and Cortical Maturation. JAMA Netw Open. 2020 Jan 3;3(1):e1919940. doi: 10.1001/jamanetworkopen.2019.19940. |
| 30626455 | Background | Olson DM, Bremault-Phillips S, King S, Metz GAS, Montesanti S, Olson JK, Hyde A, Pike A, Hoover T, Linder R, Joggerst B, Watts R. Recent Canadian efforts to develop population-level pregnancy intervention studies to mitigate effects of natural disasters and other tragedies. J Dev Orig Health Dis. 2019 Feb;10(1):108-114. doi: 10.1017/S2040174418001113. Epub 2019 Jan 10. |
| 32278792 | Background | Entringer S. Prenatal stress exposure and fetal programming of complex phenotypes: interactive effects with multiple risk factors. Neurosci Biobehav Rev. 2020 Oct;117:3-4. doi: 10.1016/j.neubiorev.2020.04.002. Epub 2020 Apr 9. No abstract available. |
| 30213491 | Background | Braun F, Hardt AK, Ehrlich L, Sloboda DM, Challis JRG, Plagemann A, Henrich W, Braun T. Sex-specific and lasting effects of a single course of antenatal betamethasone treatment on human placental 11beta-HSD2. Placenta. 2018 Sep;69:9-19. doi: 10.1016/j.placenta.2018.07.007. Epub 2018 Jul 11. |
| 12423477 | Background | Arabin B. Music during pregnancy. Ultrasound Obstet Gynecol. 2002 Nov;20(5):425-30. doi: 10.1046/j.1469-0705.2002.00844.x. No abstract available. |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D063346 | Singing |
| ID | Term |
|---|---|
| D010699 | Phonation |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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