Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
NCT ID: NCT07003048
Last Updated: 2025-06-04
Study Results
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Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-01-25
2027-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Live music intervention
Singing and dancing in small groups combined with live concerts througout pregnancy
Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building
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
1. concerts customized for pregnant women by professionals. They talk before and in between the concerts about the meaning of the music with the study attendants. The sessions take around one hour.
2. workshops in singing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn melodies of songs which they can repeat at home on a daily basis.
3. workshops in dancing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn to move with music which they can repeat at home on a daily basis.
DIGITAL GROUP The described interventions are all digitalized with interviews encouraging the second group to participate from home.
Digital music intervention
Digitalized version of singing and dancing workshops combined with recorded concerts offered to women at home throughout pregnancy
Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building
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
1. concerts customized for pregnant women by professionals. They talk before and in between the concerts about the meaning of the music with the study attendants. The sessions take around one hour.
2. workshops in singing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn melodies of songs which they can repeat at home on a daily basis.
3. workshops in dancing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn to move with music which they can repeat at home on a daily basis.
DIGITAL GROUP The described interventions are all digitalized with interviews encouraging the second group to participate from home.
Interventions
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Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building
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
1. concerts customized for pregnant women by professionals. They talk before and in between the concerts about the meaning of the music with the study attendants. The sessions take around one hour.
2. workshops in singing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn melodies of songs which they can repeat at home on a daily basis.
3. workshops in dancing led by professional coaches performed in small groups within the Philharmonic building involving pregnant women to actively learn to move with music which they can repeat at home on a daily basis.
DIGITAL GROUP The described interventions are all digitalized with interviews encouraging the second group to participate from home.
Eligibility Criteria
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Inclusion Criteria
* no severe medical or mental disease
* capable to understand german or English language
* more than 20 gestational weeks at recruitment
18 Years
50 Years
FEMALE
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Clara Angela Foundation
OTHER
Responsible Party
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Birgit Arabin
MD, PhD, Professor of OBGYN, Head of the Clara Angela Foundation
Locations
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Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Eth-SB-24-086
Identifier Type: -
Identifier Source: org_study_id
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