Clinical trial NCT07003048: Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
Official title: Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Mental Health
Maternal and Child Health Outcomes
Keywords: Music intervention
Pregnancy
Stress
Mental health
Anxiety
Depression
Fetal development
Lead sponsor: Clara Angela Foundation
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2025-06-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant women outside the above declared inclusion criteria
* more than 20 gestational weeks at recruitment

Primary outcomes:
measure: Short-term differences before and after musical interventions
timeFrame: Five minutes before and after the workshop or concert starts and ends. In total six concerts and five workshops take place.
measure: Short-term differences before and after musical interventions (Cortisol)
timeFrame: 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.
Secondary outcomes:
measure: Medium-term outcome measures (PSS)
timeFrame: 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: Medium-term outcome measures (STAI)
timeFrame: 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: Medium-term outcome measures (EPDS)
timeFrame: 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: Medium-term outcome measures
timeFrame: 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.
measure: Long-term outcome measures (AGES and STAGES)
timeFrame: 6 and 12 months after birth
measure: Long-term outcome measures (PARCA-R)
timeFrame: 24 months after birth
Other outcomes:
measure: Music performance and development of linguistic skills
timeFrame: 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: Placental and telomere data from umbilical cord blood a term
timeFrame: Up to 6 months after birth
measure: Placental and telomere data from umbilical cord blood a term
timeFrame: Directly after birth
measure: Placental and telomere data from umbilical cord blood a term
timeFrame: Up to 6 months after birth
Locations:
city: Berlin
country: Germany
facility: Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.