Newborn InfantNCT01914341
Short Term Effects of Live Music in Newborn Infants
A study testing Music in people with Newborn Infant, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial summary
The purpose of this study is to determine the effects of live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing. Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Newborn Infant
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≥ 35 weeks
- signed informed consent of the parents
- positive proof of hearing ability (TEOAE, transitory evoked otoacoustic emission)
- positive 10-minute Apgar-Score > 7
Who cannot join
- Heart defect or known cardiac arrhythmia
- other diseases of the preterm and newborn period (including infections and chromosomal aberrations)
- participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants
The purpose of this study is to determine the effects of live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing.
- Conditions
- Newborn Infant
- Being tested
- Music
- Keywords
- Infant, Newborn, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Live music played on the pentatonically tuned children's harp
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | pentatonic live music Receives: Other: Music |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
heartrate
Measured: physiological parameters are measured twice over a period of 45 minutes
Secondary outcomes (11)
Oxygen saturation
Measured: physiological parameters are measured twice over a period of 45 minutes.
Breathing rate
Measured: physiological parameters are measured twice over a period of 45 minutes
Apnoea > 4 sec per hour
Measured: physiological parameters are measured twice over a period of 45 minutes
Bradycardia < 80 bpm/h
Measured: physiological parameters are measured twice over a period of 45 minutes
Tachycardia > 200 bmp/h
Measured: physiological parameters are measured twice over a period of 45 minutes
heart rate variability-parameters (HRV)
RMSS (root mean square of successive differences) SDNN (standard deviation of normal to normal intervals) pNN50 (the proportion of NN50 (the number of pairs of successive NNs that differ by more than 50 ms) divided by total number of NNs) LF/HF (low frequency/high frequency)
Measured: physiological parameters are measured twice over a period of 45 minutes
Perfusion Index (PI)
Measured: physiological parameters are measured twice over a period of 45 minutes
Pulse-Transit-Time (PTT)
Measured: physiological parameters are measured twice over a period of 45 minutes
State Trait Anxiety Inventory
Measured: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
State of the child
Measured: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
Additional music questions
Measured: The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Newborn InfantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Principal investigator, ARCIM-Institute; University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914341
- Sponsor's protocol ID
- ARCIM_MTN04
- Status last verified
- Jan 2014
- First submitted
- 29 Jul 2013
- Last updated
- 23 Jan 2014
- Results posted
- No
Publications
Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
PubMed 16732778Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.
PubMed 10742370Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.
PubMed 12029604
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants
- ClinicalTrials.gov ID
- NCT01914341
- Acronym / sponsor ID
- ARCIM_MTN04
- Conditions
- Newborn Infant
- Keywords
- Infant, Newborn, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 2 Aug 2013 (estimated)
- 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.
The purpose of this study is to determine the effects of live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: Musicpentatonic live music |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age ≥ 35 weeks
- signed informed consent of the parents
- positive proof of hearing ability (TEOAE, transitory evoked otoacoustic emission)
- positive 10-minute Apgar-Score > 7
Key exclusion criteria (3 listed)
- Heart defect or known cardiac arrhythmia
- other diseases of the preterm and newborn period (including infections and chromosomal aberrations)
- participation in other studies
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 |
|---|---|---|
| MusicLive music played on the pentatonically tuned children's harp | Other | Music |
Primary outcome
heartrate
Time frame: physiological parameters are measured twice over a period of 45 minutes
11 secondary outcomes
Oxygen saturation
Time frame: physiological parameters are measured twice over a period of 45 minutes.
Breathing rate
Time frame: physiological parameters are measured twice over a period of 45 minutes
Apnoea > 4 sec per hour
Time frame: physiological parameters are measured twice over a period of 45 minutes
Bradycardia < 80 bpm/h
Time frame: physiological parameters are measured twice over a period of 45 minutes
Tachycardia > 200 bmp/h
Time frame: physiological parameters are measured twice over a period of 45 minutes
heart rate variability-parameters (HRV)
Time frame: physiological parameters are measured twice over a period of 45 minutes
Perfusion Index (PI)
Time frame: physiological parameters are measured twice over a period of 45 minutes
Pulse-Transit-Time (PTT)
Time frame: physiological parameters are measured twice over a period of 45 minutes
State Trait Anxiety Inventory
Time frame: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
State of the child
Time frame: Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).
Additional music questions
Time frame: The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
- Background: PubMed 16732778Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
- Background: PubMed 10742370Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. doi: 10.1542/peds.105.4.e49.
- Background: PubMed 12029604Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.
Related trials for Newborn Infant
RecruitingObservational study
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
Healthy Newborn Infants
RecruitingPhase 1
A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
RecruitingObservational study
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
Neonatal Disease
Not yet recruiting
Postpartum Care in the NICU Multi-Site Breastfeeding
Postpartum Complication, Postpartum
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
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. This study is not recruiting at the moment.
Jan Vagedes, Dr. principal investigator
ARCIM-Institute; University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Newborn Infant, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jan 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heartrate (time frame: physiological parameters are measured twice over a period of 45 minutes). 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 NCT01914341, which also lists 3 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 23 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.