PreTerm BirthNCT03023267
The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction
A study testing Music therapy and Kangaroo care and Kangaroo Care alone in people with PreTerm Birth and Stress Reaction, run by Meir Medical Center at 1 site in Israel.
Trial summary
The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs… Read more about this study
- Who is it for?
- Ages 4 to 18 weeks
- Conditions the study is for
- PreTerm Birth, Stress Reaction
- What is being tested?
- Music therapy and Kangaroo care and Kangaroo Care alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Aug 2017to 20 Dec 2019
- 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 4 to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants ≤ 37 weeks' gestation
- Clinically stable preterm
- Hearing confirmed by distortion product oto- acoustic emissions
Who cannot join
- Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
- Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
- Parents refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).
The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
Read the detailed description
Premature infants and their parents are prone to high anxiety levels and a risk of experiencing trauma due to the preterm birth and its implications. Facing various emotional physical and neural high-risk factors may lead to continuous stress reactions in both the infant and parents, affecting their well being, the parent-infant relationship and the infant's medical state outcome. Attending to both infants' emotional and physiological needs of stability and comfort, as well as parents' support, can lead to an improvement in the premature infants' medical state and the parent-infant bonding process. Furthermore, reducing stress reaction facilitates perceptual memory and learning in premature infants. Two well established interventions in the neonatal care aiming to address the varied premature-family needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports over the last three decades, regarding each modality, has shown beneficial effects in improvement and stabilization of infants' medical state, inclusion of parents in their infants' treatment and in facilitation of meaningful parent-infant interactions to promoting bonding patterns. However, a major lack of rigorous Randomized control studies presenting the clinical applications of MT techniques and methods in the NICU care exists, as well as only few research have positioned the parents in center of investigation, and/or presented their outcome and perspective. Accordingly, only few research have investigated the combination of MT and KC through an RCT. The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
- Conditions
- PreTerm Birth, Stress Reaction
- Being tested
- Music therapy and Kangaroo care, Kangaroo Care alone
- Medical subject headings
- Premature Birth, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy and Kangaroo careBehavioural
Mother holding baby in skin to skin position while singing
Kangaroo Care aloneBehavioural
Mother holding baby in skin to skin position without singing
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization Receives: Behavioral: Music therapy and Kangaroo care |
| Control | Active comparator | Applying only Kangaroo care to mothers and fathers during their stay in the NICU Receives: Behavioral: Kangaroo Care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
parasympathetic tone
The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of >0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.
Measured: During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start28 Aug 2017
- Primary completion10 Oct 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreTerm BirthStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shmuel Arnon, Meir Medical Center
- Investigators
- Rachel Grause, RD, Study chair, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023267
- Sponsor's protocol ID
- 0283-15-MMC
- Status last verified
- Feb 2020
- First submitted
- 10 Jan 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yakobson D, Arnon S, Gold C, Elefant C, Litmanovitz I, Beck BD. Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol. J Music Ther. 2020 May 2;57(2):219-242. doi: 10.1093/jmt/thaa002.
PubMed 32112555
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).
- ClinicalTrials.gov ID
- NCT03023267
- Acronym / sponsor ID
- 0283-15-MMC
- Conditions
- PreTerm Birth, Stress Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 18 Jan 2017 (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 current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
Detailed description
Premature infants and their parents are prone to high anxiety levels and a risk of experiencing trauma due to the preterm birth and its implications. Facing various emotional physical and neural high-risk factors may lead to continuous stress reactions in both the infant and parents, affecting their well being, the parent-infant relationship and the infant's medical state outcome. Attending to both infants' emotional and physiological needs of stability and comfort, as well as parents' support, can lead to an improvement in the premature infants' medical state and the parent-infant bonding process. Furthermore, reducing stress reaction facilitates perceptual memory and learning in premature infants. Two well established interventions in the neonatal care aiming to address the varied premature-family needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports over the last three decades, regarding each modality, has shown beneficial effects in improvement and stabilization of infants' medical state, inclusion of parents in their infants' treatment and in facilitation of meaningful parent-infant interactions to promoting bonding patterns. However, a major lack of rigorous Randomized control studies presenting the clinical applications of MT techniques and methods in the NICU care exists, as well as only few research have positioned the parents in center of investigation, and/or presented their outcome and perspective. Accordingly, only few research have investigated the combination of MT and KC through an RCT. The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Behavioral: Music therapy and Kangaroo careApplying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization |
| Control | Active comparator | Behavioral: Kangaroo Care aloneApplying only Kangaroo care to mothers and fathers during their stay in the NICU |
Who may qualify
- Ages
- 4 to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants ≤ 37 weeks' gestation
- Clinically stable preterm
- Hearing confirmed by distortion product oto- acoustic emissions
Key exclusion criteria (3 listed)
- Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
- Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
- Parents refusal to participate
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 |
|---|---|---|
| Music therapy and Kangaroo careMother holding baby in skin to skin position while singing | Behavioural | Interventional |
| Kangaroo Care aloneMother holding baby in skin to skin position without singing | Behavioural | Control |
Primary outcome
parasympathetic tone
Time frame: During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age
The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of >0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.
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 25 Feb 2020.
- Derived from this study: PubMed 32112555Yakobson D, Arnon S, Gold C, Elefant C, Litmanovitz I, Beck BD. Music Therapy for Preterm Infants and Their Parents: A Cluster-Randomized Controlled Trial Protocol. J Music Ther. 2020 May 2;57(2):219-242. doi: 10.1093/jmt/thaa002.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rachel Grause, RD study chair
Meir Medical Center
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 therapy and Kangaroo care and Kangaroo Care alone in people with PreTerm Birth and Stress Reaction, run by Meir Medical Center at 1 site in Israel.
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 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 25 Feb 2020. 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 Israel. 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?
parasympathetic tone (time frame: During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age). 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 NCT03023267, which also lists 1 linked publication.
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 25 Feb 2020.