GastroschisisMAGICNCT01469208
Music Therapy: An Adjunct To Gastroschisis Infants' Care
An observational study of Gastroschisis, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an… Read more about this study
- Who is it for?
- Ages 1 week to 6 months
- Conditions the study is for
- Gastroschisis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- Phase
- Observational
- 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 1 week to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: 30 infants born with gastroschisis will be enrolled over a 2yr period. All babies will be newborns admitted to the NICU. The babies enrolled will be both male and female and diverse in race and ethnicity.
Who may be able to join
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
Who cannot join
- 1. Neonatologist feels patient/family would not be an acceptable research candidate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Childrens Hospitals and Clinics of MN
Minneapolis, Minnesota, 55404
Catherine T Worwa, 612-813-6864, cathy.worwa@childrensmn.org
Ellen Bendel-Stenzel, MD
About this study
Official title: The Effect of Music Therapy On Infants Born With Gastroschisis
The investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.
Read more
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
Read the detailed description
Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking \& touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, NICU inpatients, Post surgical repair, Music Therapy
- Medical subject headings
- Gastroschisis
What is being measured
The primary outcome is the main question the study is designed to answer.
Music Therapy will produce stable physiologic, states as well as, positive behavior states
Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Bendel-Stenzel, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469208
- Sponsor's protocol ID
- 1110096A
- Acronym
- MAGIC
- Status last verified
- Jul 2013
- First submitted
- 8 Nov 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy On Infants Born With Gastroschisis
- ClinicalTrials.gov ID
- NCT01469208
- Acronym / sponsor ID
- MAGIC / 1110096A
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, NICU inpatients, Post surgical repair, Music Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Nov 2011 (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 investigators hope to determine if music therapy will have beneficial effects on physiologic parameters, behavioral states, and pain scale evaluations in infants with gastroschisis defects and if music therapy promotes parental/caregiver relaxation and demonstrates to the parent/caregiver that music is an effective tool to calm and soothe their infant at risk for chronic gastrointestinal discomfort.
Babies will be enrolled during the perinatal period, with therapy to begin after surgical repair of the gastroschisis defect and when the neonatologist deems the baby stable enough for music therapy intervention. Enrolled subjects may receive up to 3 music therapy sessions/week and these sessions may continue until discharge. There is no follow up after discharge.
Each one hour session (20-30 minutes of music and 30 minutes of quiet) will include:
- Pre music therapy behavior state will be assessed using CRIES scale and recorded.
- Five minutes of baseline vital signs will be recorded.
- Music therapy lasting 20-30 minutes, will start. Music therapist will use guitar and lap harp to perform live lullaby tupe music with or with out vocals. Decibel levels will be maintained at 65-75dB. Session will stop if infant shows any signs of distress/agitation. Vital signs will be collected every 1-4 minutes during music session.
- After session behavior state using CRIES scale will be recorded.
- Family/caregiver will be given a questionnaire to fill out.
- 30 min of quiet will start.
- At the end of quiet time, behavior state and vital signs will be recorded for the last time.
Detailed description
Prior to starting the music therapy session, family/caregivers, if present, will be informed of study session progression. They will be reminded of appropriate behavioral protocol to maintain therapeutic environment during session - i.e. minimal taking \& touching, cell phones off etc. A "Do Not Disturb - Music Therapy Session in Progress" will be posted outside pts room on the door.
Behavioral state data and vitals signs collected during sessions will be entered into a database. Also recorded, will be general information about the baby and its mother, such as, gestational age, apgar scores, mothers age and race, number of days post surgical repair etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 30 infants born with gastroschisis will be enrolled over a 2yr period. All babies will be newborns admitted to the NICU. The babies enrolled will be both male and female and diverse in race and ethnicity.
Key inclusion criteria (3 listed)
- Diagnosis of Gastroschisis
- Patient is stable enough to receive music therapy as determined by Neonatologist
- Patient has passed their newborn hearing screen
Key exclusion criteria (1 listed)
- 1. Neonatologist feels patient/family would not be an acceptable research candidate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Music Therapy will produce stable physiologic, states as well as, positive behavior states
Time frame: 3 years
Vital signs monitor data and stress assessment scores will be collected before, during and post Music Therapy sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2013. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine T Worwa, LRT, BS, CCRP (612-813-6864, cathy.worwa@childrensmn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Music Therapy will produce stable physiologic, states as well as, positive behavior states (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2013.