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Music Therapy for Critical Illness
N/A
Recruiting
Led By Jessica M Jarvis, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up interviews conducted within 1 month of completing primary data collection
Awards & highlights
Summary
This trial will compare the effects of live and recorded music listening on stress and pain biomarkers in children receiving mechanical ventilation in the pediatric intensive care unit.
Who is the study for?
This trial is for children aged 5-17 who are intubated and on mechanical ventilation in the PICU, expected to stay over 72 hours. It's not for kids whose caregiver can't communicate in English, those with bilateral deafness, musicogenic epilepsy, COVID-19 diagnosis, new traumatic brain injury or unlikely to survive their PICU stay.
What is being tested?
The study aims to compare how live and recorded music affect stress and pain indicators in ventilated children at the PICU. Each child will experience both interventions randomly during their stay to see which one works better.
What are the potential side effects?
Since this trial involves listening to music as an intervention, there are no direct medical side effects expected. However, individual responses to music may vary based on personal preferences and psychological state.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ interviews conducted within 1 month of completing primary data collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~interviews conducted within 1 month of completing primary data collection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Interleukin-6 (IL6) pre-post condition
Change in cortisol pre-post condition
HF to LF ration (HF/LF) Heart Rate Variability
+3 moreSecondary study objectives
Acceptability
Change in Face Legs Activity Consolability and Crying (FLACC)
Change in Visual Analogue Scale of Anxiety
Side effects data
From 2012 Phase 3 trial • 844 Patients • NCT0133620518%
ABDOMINAL PAIN
14%
DIARRHOEA
10%
NAUSEA
9%
BACK PAIN
9%
HEADACHE
7%
FLATULENCE
6%
ABDOMINAL PAIN UPPER
6%
ARTHRALGIA
6%
BRONCHITIS
6%
NASOPHARYNGITIS
6%
UPPER RESPIRATORY TRACT INFECTION
5%
URINARY TRACT INFECTION
5%
VOMITING
5%
COUGH
4%
FALL
4%
PAIN IN EXTREMITY
4%
SINUSITIS
3%
FATIGUE
3%
PYREXIA
3%
NASAL CONGESTION
3%
MUSCLE SPASMS
3%
HYPERTENSION
3%
GASTROENTERITIS VIRAL
3%
ANXIETY
3%
INSOMNIA
3%
HYPERHIDROSIS
2%
CHILLS
2%
DIZZINESS
2%
ABDOMINAL DISCOMFORT
2%
ABDOMINAL DISTENSION
2%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
OEDEMA PERIPHERAL
2%
CONTUSION
2%
INFLUENZA
2%
DEPRESSION
1%
DEHYDRATION
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
HYPERCHOLESTEROLAEMIA
1%
PNEUMONIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
NKTR-118 25 mg
Usual Care
Trial Design
6Treatment groups
Experimental Treatment
Group I: Usual care > Recorded music > Live musicExperimental Treatment3 Interventions
Order of conditions for the day
Group II: Usual Care > Live music > Recorded musicExperimental Treatment3 Interventions
Order of conditions for the day
Group III: Recorded music > Usual care > Live musicExperimental Treatment3 Interventions
Order of conditions for the day
Group IV: Recorded music > Live music > Usual careExperimental Treatment3 Interventions
Order of conditions for the day
Group V: Live music > Usual Care > Recorded musicExperimental Treatment3 Interventions
Order of conditions for the day
Group VI: Live music > Recorded music > Usual CareExperimental Treatment3 Interventions
Order of conditions for the day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Live music
2010
N/A
~350
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,762 Previous Clinical Trials
16,347,832 Total Patients Enrolled
14 Trials studying Critical Illness
8,006 Patients Enrolled for Critical Illness
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,663 Total Patients Enrolled
6 Trials studying Critical Illness
2,353 Patients Enrolled for Critical Illness
Jessica M Jarvis, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Critical Illness
38 Patients Enrolled for Critical Illness
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 2 months and 17 years old.I am on a breathing machine.My child is deaf, has music-triggered seizures, and is getting muscle relaxant infusions.My child was recently admitted for a new brain injury.My child has been diagnosed with COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care > Recorded music > Live music
- Group 2: Live music > Usual Care > Recorded music
- Group 3: Usual Care > Live music > Recorded music
- Group 4: Recorded music > Usual care > Live music
- Group 5: Recorded music > Live music > Usual care
- Group 6: Live music > Recorded music > Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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