Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring

NCT07003048 | Recruiting DMC

• 1 other identifier: Eth-SB-24-086
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Mental Health; Maternal and Child Health Outcomes

Keywords

Music intervention; Pregnancy; Stress; Mental health; Anxiety; Depression; Fetal development

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (6)

• 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.

• 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.

• 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

• 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.

• Long-term outcome measures (AGES and STAGES)

  6 and 12 months after birth

Other Outcomes (4)

• Music performance and development of linguistic skills

  1. Gestational age between 12 and 18 weeks, 2. gestational age between 22 and 28 weeks, 3. gestational age between 30 and 36 weeks

• Placental and telomere data from umbilical cord blood a term

  Up to 6 months after birth

• Placental and telomere data from umbilical cord blood a term

  Directly after birth

Study Arms (2)

Live music intervention

EXPERIMENTAL

Singing and dancing in small groups combined with live concerts througout pregnancy

Behavioral: Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building

Digital music intervention

ACTIVE COMPARATOR

Digitalized version of singing and dancing workshops combined with recorded concerts offered to women at home throughout pregnancy

Behavioral: Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building

Interventions

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 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; Live music intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only pregnant women from 12 gestational weeks onwards up to birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• more than 20 gestational weeks at recruitment

Sponsors & Collaborators

• Clara Angela Foundation: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics

Berlin, State of Berlin, D 14193, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 28011436 BACKGROUND

• 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.

  PMID: 32911996 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.

  PMID: 28706188 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.

  PMID: 31995213 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.

  PMID: 30626455 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.

  PMID: 32278792 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.

  PMID: 30213491 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.

  PMID: 12423477 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders; Depression

Interventions

Singing

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Prof. Birgit Arabin, MD, PhD

CONTACT

+4915150470484; bine.clara.angela@gmail.com

Uwe Wiards

CONTACT

uwe@wiards.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of OBGYN, Head of the Clara Angela Foundation

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: June 4, 2025
• Study Start: January 25, 2025
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)