Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
171 participants
INTERVENTIONAL
2023-03-20
2027-05-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Live music > Recorded music > Usual Care
Order of conditions for the day
Live music
Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
Recorded music
Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual care
Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Recorded music > Usual care > Live music
Order of conditions for the day
Live music
Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
Recorded music
Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual care
Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual Care > Live music > Recorded music
Order of conditions for the day
Live music
Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
Recorded music
Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual care
Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Live music > Usual Care > Recorded music
Order of conditions for the day
No interventions assigned to this group
Recorded music > Live music > Usual care
Order of conditions for the day
No interventions assigned to this group
Usual care > Recorded music > Live music
Order of conditions for the day
Live music
Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
Recorded music
Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual care
Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Interventions
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Live music
Live Music. A board-certified music therapist will provide live music (singing with instrument accompaniment) of child preferred songs, per caregiver report, with the tempo entrained to the child's respiratory rate at intervention start and decreased as needed to facilitate relaxation, with a target tempo of 60-80 beats per minute (BPM). Song choices will be based on patient preferences, per caregiver report, and performed with relaxing characteristics (steady rhythm and volume)
Recorded music
Recorded Music. MP3 players will be loaded with a recorded music playlist of the child's preferred songs, per caregiver report, and connected to two small speakers that are to be placed at either side of the head of the bed. Speakers will be tested with sound level meter and volume control set at 50-60 decibels. A member of the study team will stay at bedside throughout the recorded music condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Usual care
Usual Care. A pharmacologic approach to ameliorating stress and pain in MV children is standard of care in CHP's PICU. CHP provides weight-based guidelines to aid clinical decisions on medications for sedation and analgesia. Bedside nurses assess the child's sedation and pain scores once an hour and administered PRN medications as needed, based on clinical judgement, using CHP's PICU weight-based guidelines. For example, if a child has a pain score of \>1-2 above goal, guidelines suggest providing a fentanyl dose of 0.5 mcg/kg and assessing again in 1 hour. We will include usual care as a third condition to explore how our selected biomarkers vary over 20 min. without the addition of any musical stimuli. A member of the study team will stay at bedside throughout the usual care condition. Study team member will log time of session and complete a checklist with open-response option to note relevant information (e.g., Session interruptions from other staff).
Eligibility Criteria
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Inclusion Criteria
* intubated and receiving MV
* expected to have a PICU stay of \>72 hours
Exclusion Criteria
* The child is not expected to survive the PICU stay
* The child has deafness in both ears, has a history of musicogenic epilepsy, is receiving neuromuscular blockade infusion
* The child has a diagnosis of COVID-19
* The child was admitted for a new traumatic brain injury
2 Months
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Jessica Jarvis
Postdoctoral Research Fellow
Principal Investigators
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Jessica M Jarvis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Jessica M Jarvis, PhD
Role: primary
References
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Chlan 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.
Liu 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.
Bush HI, LaGasse AB, Collier EH, Gettis MA, Walson K. Effect of Live Versus Recorded Music on Children Receiving Mechanical Ventilation and Sedation. Am J Crit Care. 2021 Sep 1;30(5):343-349. doi: 10.4037/ajcc2021646.
Other Identifiers
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STUDY22080069
Identifier Type: -
Identifier Source: org_study_id