Neurological DisordersNCT01858350
Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
A study testing Active Music Therapy, Passive Music Therapy and Distraction Therapy in people with Neurological Disorders, run by Wayne State University at 1 site in United States.
Trial summary
The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Neurological Disorders
- What is being tested?
- Active Music Therapy, Passive Music Therapy and Distraction Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2012
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 1-12 years undergoing MRI studies
Who cannot join
- Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University and Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies
The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.
- Conditions
- Neurological Disorders
- Being tested
- Active Music Therapy, Passive Music Therapy, Distraction Therapy
- Keywords
- CAM, Sedation, MRI, Music Therapy
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Music TherapyOther
Passive Music TherapyOther
Distraction TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Active Music Therapy | Other | Active Music Therapy: A music therapist plays music to patients for 15 minutes Receives: Other: Active Music Therapy |
| Passive Music Therapy | Other | Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes Receives: Other: Passive Music Therapy |
| No intervention | No intervention | Not described |
| Distraction Therapy | Other | Distraction Therapy: A child life specialist plays with patients for 15 minutes Receives: Other: Distraction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for sedation medications for MRI is reduced
Intervention is performed prior to sedation. Following sedation, the patient undergoes MRI. After the MRI is completed, the amount of sedation given to the patient is recorded. No other follow up is required.
Measured: The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.
Secondary outcomes (1)
To measure the effect of the interventions on salivary cortisol and inflammatory cytokines
The aim of this measure was to determine if the interventions changed the levels of salivary cortisol and inflammatory cytokines
Measured: Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisordersStudies 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
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambika Mathur, Wayne State University
- Investigators
- Ambika MATHUR, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858350
- Sponsor's protocol ID
- RC1AT005699
- Status last verified
- May 2013
- First submitted
- 13 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies
- ClinicalTrials.gov ID
- NCT01858350
- Acronym / sponsor ID
- RC1AT005699
- Conditions
- Neurological Disorders
- Keywords
- CAM, Sedation, MRI, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 May 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 investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Music Therapy | Other | Other: Active Music TherapyActive Music Therapy: A music therapist plays music to patients for 15 minutes |
| Passive Music Therapy | Other | Other: Passive Music TherapyPassive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes |
| No intervention | No intervention | – |
| Distraction Therapy | Other | Other: Distraction TherapyDistraction Therapy: A child life specialist plays with patients for 15 minutes |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 1-12 years undergoing MRI studies
Key exclusion criteria (1 listed)
- Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations
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 |
|---|---|---|
| Active Music Therapy | Other | Active Music Therapy |
| Passive Music Therapy | Other | Passive Music Therapy |
| Distraction Therapy | Other | Distraction Therapy |
Primary outcome
Need for sedation medications for MRI is reduced
Time frame: The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.
Intervention is performed prior to sedation. Following sedation, the patient undergoes MRI. After the MRI is completed, the amount of sedation given to the patient is recorded. No other follow up is required.
1 secondary outcome
To measure the effect of the interventions on salivary cortisol and inflammatory cytokines
Time frame: Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).
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 21 May 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.
Ambika MATHUR, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Music Therapy, Passive Music Therapy and Distraction Therapy in people with Neurological Disorders, run by Wayne State University 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 1 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: finished, as of the sponsor's last update on 21 May 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?
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?
Need for sedation medications for MRI is reduced (time frame: The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.). 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 21 May 2013.