Music Listening: A Mechanistic Trial

Официальное название

Music Listening Interventions for Children Receiving Mechanical Ventilation: A Mechanistic Trial

Обзор

A randomized within-subject crossover trial to compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit.

Подробное описание

Children who are critically ill and receiving mechanical ventilation are at increased risks for experiencing high levels of stress and pain, which negatively impacts immediate and long-term health. The current standard of care for treating stress and pain is to provide analgesic and sedative medications, which are associated with increased risk of delirium and posttraumatic stress disorder. This randomized within-subject crossover trial will compare the effects of live and recorded music listening on biomarkers of stress and pain among children receiving mechanical ventilation in the pediatric intensive care unit, to identify the key components of a music listening intervention and explore its mechanism of action, i.e., the biological pathway through which music listening decreases stress and pain.

Вмешательства

• Поведенческое 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)
• Поведенческое 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
• Другое 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 providi

Первичные конечные точки

• Change in cortisol pre-post condition [Срок оценки: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days]
• Change in Interleukin-6 (IL6) pre-post condition [Срок оценки: Change from baseline to 30 min. and 60-90 min. post each condition for up to 3 days]
• High Frequency (HF) Heart Rate Variability [Срок оценки: 1 hour prior through 2 hours post each condition, up to 3 days]
• Low Frequency (LF) Heart Rate Variability [Срок оценки: 1 hour prior through 2 hours post each condition, up to 3 days]
• HF to LF ration (HF/LF) Heart Rate Variability [Срок оценки: 1 hour prior through 2 hours post each condition, up to 3 days]
• Standard Deviation of Normal to Normal (SDNN) Heart Rate Variability [Срок оценки: 1 hour prior through 2 hours post each condition, up to 3 days]

Вторичные конечные точки (3)

• Acceptability [Срок оценки: Interviews conducted within 1 month of completing primary data collection]
• Change in Visual Analogue Scale of Anxiety [Срок оценки: Change <30 min. pre-post each condition for up to 3 days]
• Change in Face Legs Activity Consolability and Crying (FLACC) [Срок оценки: Change <30 min. pre-post each condition for up to 3 days]

Критерии участия

Критерии включения

• 2 months -17 years old
• intubated and receiving MV
• expected to have a PICU stay of >72 hours

Критерии исключения

• Primary caregiver does not read, write, and speak English
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UPMC Children's Hospital of Pittsburgh — Pittsburgh

Публикации

• 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. PMID 23689789
• 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. PMID 31652195
• 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. PMID 34467386

Идентификаторы

NCT: NCT05541029 · STUDY22080069 · K23HD106011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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