PregnancyMusicMumsNCT07003048
Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
A study testing Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building in people with Pregnancy and Mental Health, run by Clara Angela Foundation at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Mental Health, Maternal and Child Health Outcomes
- What is being tested?
- Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant women outside the above declared inclusion criteria
- more than 20 gestational weeks at recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uwe Wiards contact
Germany1 site, 1 recruiting
- Recruiting
Clara Angela Foundation Berlin and Foundation of the Berlin Philharmonics
Berlin, State of Berlin, D 14193
Birgit Arabin, MD, PhD, +4915150470484, bine.clara.angela@gmail.com
Uwe Wiards, +49 15157810435, uwe@wiards.de
About this study
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.
Read more
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
- Being tested
- Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building
- Keywords
- Music intervention, Pregnancy, Stress, Mental health, Anxiety, Depression, Fetal development
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing, dancing in small groups and active listening to live music at the Berlin Philharmony buildingBehavioural
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
- 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.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Live music intervention | Experimental | Singing and dancing in small groups combined with live concerts througout pregnancy Receives: 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 Receives: Behavioral: Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start25 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clara Angela Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Birgit Arabin, Clara Angela Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003048
- Sponsor's protocol ID
- Eth-SB-24-086
- Acronym
- MusicMums
- Status last verified
- May 2025
- First submitted
- 5 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We promied to evaluate all data following the german law of data protection and to handle the data anonomously.
Publications
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.
PubMed 28011436Verner 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.
PubMed 32911996Faraji 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.
PubMed 28706188Wu 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.
PubMed 31995213Olson 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.
PubMed 30626455Entringer 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.
PubMed 32278792Braun 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.
PubMed 30213491Arabin 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.
PubMed 12423477
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life vs. Digital Music Interventions Performed by Professionals Throughout Pregnancy to Increase Mental Health for Mothers and Their Offspring
- ClinicalTrials.gov ID
- NCT07003048
- Acronym / sponsor ID
- MusicMums / Eth-SB-24-086
- Conditions
- Pregnancy, Mental Health, Maternal and Child Health Outcomes
- Keywords
- Music intervention, Pregnancy, Stress, Mental health, Anxiety, Depression, Fetal development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Clara Angela FoundationUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live music intervention | Experimental | Behavioral: Singing, dancing in small groups and active listening to live music at the Berlin Philharmony buildingSinging and dancing in small groups combined with live concerts througout pregnancy |
| Digital music intervention | Active comparator | Behavioral: Singing, dancing in small groups and active listening to live music at the Berlin Philharmony buildingDigitalized version of singing and dancing workshops combined with recorded concerts offered to women at home throughout pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant women outside the above declared inclusion criteria
- more than 20 gestational weeks at recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singing, dancing in small groups and active listening to live music at the Berlin Philharmony buildingPregnant 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. | Behavioural | Digital music intervention, Live music intervention |
Primary outcome
Short-term differences before and after musical interventions
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Medium-term outcome measures (PSS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 6 and 12 months after birth
Long-term outcome measures (PARCA-R)
Time frame: 24 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 28011436Mannel 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.
- Background: PubMed 32911996Verner 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.
- Background: PubMed 28706188Faraji 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.
- Background: PubMed 31995213Wu 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.
- Background: PubMed 30626455Olson 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.
- Background: PubMed 32278792Entringer 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.
- Background: PubMed 30213491Braun 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.
- Background: PubMed 12423477Arabin 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.
- Individual participant dataSharing planned: No. We promied to evaluate all data following the german law of data protection and to handle the data anonomously.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uwe Wiards contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing, dancing in small groups and active listening to live music at the Berlin Philharmony building in people with Pregnancy and Mental Health, run by Clara Angela Foundation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Birgit Arabin, MD, PhD (+4915150470484, bine.clara.angela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term differences before and after musical interventions (time frame: Five minutes before and after the workshop or concert starts and ends. In total six concerts and five workshops take place.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003048, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.