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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music therapy | Experimental | Music listening intervention provided by a board certified music therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of participant recruitment | Feasibility of participant recruitment will be determined via recruitment rate | Throughout study completion, anticipated 1 year |
| Feasibility of participant retention | Feasibility of participant retention will be determined via retention | Post-intervention completion, anticipated 2 weeks |
| Feasibility of protocol | Feasibility of protocol will be determined via percentage of sessions that adhere to protocol | 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 | 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. | Post-intervention, anticipated 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate | Change in child participant heart rate during intervention | Throughout intervention completion, anticipated 2 weeks |
| Change in oxygen saturation | Change in child participant oxygen saturation during intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica M Jarvis, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25490233 | Background | 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. | |
| 23689789 | Background | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Single-arm feasibility trial
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| Throughout intervention completion, anticipated 2 weeks |
| Change in blood pressure | Change in child participant blood pressure during intervention | Throughout intervention completion, anticipated 2 weeks |
| Change in saliva cortisol | Change in child and caregiver participant saliva cortisol levels pre-post intervention | Throughout intervention completion, anticipated 2 weeks |
| Change in saliva inflammatory biomarkers | Change in child participant saliva inflammatory biomarker levels pre-post intervention | 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. | Throughout intervention completion, anticipated 2 weeks |
| 31652195 | Background | 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. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |