Critical IllnessNCT04280744
Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
A study testing Music therapy in people with Critical Illness and Hypoxia, Brain, run by University of Pittsburgh at 1 site in United States.
Trial summary
Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Critical Illness, Hypoxia, Brain
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 1 Feb 2022
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent/caregiver aged 18 years or older.
- Children aged 2 months - 17 years admitted to the PICU with an expected length of stay greater than 72 hours
- Child is receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support setting
Who cannot join
- The legal guardian is unclear,
- Caregiver does not read, write, and speak English
- Child is not expected to survive that PICU stay or has care limitations in place
- Child has deafness in both ears, in foster care or justice system, or experiences musicogenic epilepsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation.
Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff.
Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.
- Conditions
- Critical Illness, Hypoxia, Brain
- Being tested
- Music therapy
- Medical subject headings
- Critical Illness, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Also called Music listening
Patient preferred song will be provided in a sedative manor (e.g., 60-80 beats per minute) using live music (singing with guitar accompaniment) by a board certified music therapist.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | Music listening intervention provided by a board certified music therapist. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant recruitment
Feasibility of participant recruitment will be determined via recruitment rate
Measured: Throughout study completion, anticipated 1 year
Feasibility of participant retention
Feasibility of participant retention will be determined via retention
Measured: Post-intervention completion, anticipated 2 weeks
Feasibility of protocol
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Measured: Throughout study completion, anticipated 1 year
Feasibility of data collection
Feasibility of data collection will be determined via percentage of participants with complete data capture
Measured: Throughout study completion, anticipated 1 year
Acceptability of intervention among participants
Acceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.
Measured: Post-intervention, anticipated 2 weeks
Secondary outcomes (6)
Change in heart rate
Change in child participant heart rate during intervention
Measured: Throughout intervention completion, anticipated 2 weeks
Change in oxygen saturation
Change in child participant oxygen saturation during intervention
Measured: Throughout intervention completion, anticipated 2 weeks
Change in blood pressure
Change in child participant blood pressure during intervention
Measured: Throughout intervention completion, anticipated 2 weeks
Change in saliva cortisol
Change in child and caregiver participant saliva cortisol levels pre-post intervention
Measured: Throughout intervention completion, anticipated 2 weeks
Change in saliva inflammatory biomarkers
Change in child participant saliva inflammatory biomarker levels pre-post intervention
Measured: Throughout intervention completion, anticipated 2 weeks
Visual Analog Scale - Anxiety
Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.
Measured: Throughout intervention completion, anticipated 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start29 Jun 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2022
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm feasibility trial
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Jessica Jarvis, University of Pittsburgh
- Investigators
- Jessica M Jarvis, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280744
- Sponsor's protocol ID
- STUDY19100263
- Status last verified
- Feb 2022
- First submitted
- 19 Feb 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.
PubMed 25490233Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
PubMed 23689789Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159.
PubMed 31652195
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
- ClinicalTrials.gov ID
- NCT04280744
- Acronym / sponsor ID
- STUDY19100263
- Conditions
- Critical Illness, Hypoxia, Brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 21 Feb 2020 (actual)
- 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.
Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation.
Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff.
Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Other: Music therapyMusic listening intervention provided by a board certified music therapist. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent/caregiver aged 18 years or older.
- Children aged 2 months - 17 years admitted to the PICU with an expected length of stay greater than 72 hours
- Child is receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support setting
Key exclusion criteria (4 listed)
- The legal guardian is unclear,
- Caregiver does not read, write, and speak English
- Child is not expected to survive that PICU stay or has care limitations in place
- Child has deafness in both ears, in foster care or justice system, or experiences musicogenic epilepsy.
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 therapyAlso: Music listeningPatient preferred song will be provided in a sedative manor (e.g., 60-80 beats per minute) using live music (singing with guitar accompaniment) by a board certified music therapist. | Other | Music therapy |
Primary outcome
Feasibility of participant recruitment
Time frame: Throughout study completion, anticipated 1 year
Feasibility of participant recruitment will be determined via recruitment rate
Feasibility of participant retention
Time frame: Post-intervention completion, anticipated 2 weeks
Feasibility of participant retention will be determined via retention
Feasibility of protocol
Time frame: Throughout study completion, anticipated 1 year
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Feasibility of data collection
Time frame: Throughout study completion, anticipated 1 year
Feasibility of data collection will be determined via percentage of participants with complete data capture
Acceptability of intervention among participants
Time frame: Post-intervention, anticipated 2 weeks
Acceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.
6 secondary outcomes
Change in heart rate
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in oxygen saturation
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in blood pressure
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in saliva cortisol
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in saliva inflammatory biomarkers
Time frame: Throughout intervention completion, anticipated 2 weeks
Visual Analog Scale - Anxiety
Time frame: Throughout intervention completion, anticipated 2 weeks
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 3 Feb 2022.
- Background: PubMed 25490233Bradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9.
- Background: PubMed 23689789Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
- Background: PubMed 31652195Liu MH, Zhu LH, Peng JX, Zhang XP, Xiao ZH, Liu QJ, Qiu J, Latour JM. Effect of Personalized Music Intervention in Mechanically Ventilated Children in the PICU: A Pilot Study. Pediatr Crit Care Med. 2020 Jan;21(1):e8-e14. doi: 10.1097/PCC.0000000000002159.
- 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.
Jessica M Jarvis, PhD principal investigator
University of Pittsburgh
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 in people with Critical Illness and Hypoxia, Brain, run by University of Pittsburgh 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 4 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 3 Feb 2022. 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?
Feasibility of participant recruitment (time frame: Throughout study completion, anticipated 1 year). The study lists 5 primary outcomes in all. 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 NCT04280744, 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 3 Feb 2022.