UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
NCT Number: NCT04280744
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.
Looking for future studies?
Notify Me2 month–17 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15224, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Music listening
Time frame: Throughout study completion, anticipated 1 year
Feasibility of participant recruitment will be determined via recruitment rate
Time frame: Post-intervention completion, anticipated 2 weeks
Feasibility of participant retention will be determined via retention
Time frame: Throughout study completion, anticipated 1 year
Feasibility of protocol will be determined via percentage of sessions that adhere to protocol
Time frame: Throughout study completion, anticipated 1 year
Feasibility of data collection will be determined via percentage of participants with complete data capture
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.
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in child participant heart rate during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in child participant oxygen saturation during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in child participant blood pressure during intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in child and caregiver participant saliva cortisol levels pre-post intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in child participant saliva inflammatory biomarker levels pre-post intervention
Time frame: Throughout intervention completion, anticipated 2 weeks
Change in caregiver participant self-reported anxiety pre-post intervention. 0-100, higher score indicates greater anxiety level.
University of Pittsburgh
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04612348
Critical Illness, Disease Attributes
Columbus, Ohio, United States
View Trial DetailsNCT03195127
Chronic Disease, Critical Illness
Baltimore, Maryland, United States
View Trial DetailsNCT07020637
Critical Illness, Disease Attributes
Las Vegas, Nevada, United States
View Trial DetailsNCT07579728
Critical Illness, Disease Attributes
Istanbul, Turkey (Türkiye)
View Trial Details