A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children

Abstract Objective To demonstrate feasibility of a music medicine intervention trial in pediatric intensive care and to obtain information on sedation and analgesia dose variation to plan a larger trial. Material and methods Pilot randomized controlled trial (RCT) was conducted at the Stollery Children’s Hospital general and cardiac intensive care units (PICU/PCICU). The study included children 1 month to 16 years of age on mechanical ventilation and receiving sedation drugs. Patients were randomized in a 1:1:1 ratio to music, noise cancellation or control. The music group received classical music for 30 min three times/day using headphones. The noise cancellation group received the same intervention but with no music. The control group received usual care. Results A total of 60 patients were included. Average enrollment rate was 4.8 patients/month, with a consent rate of 69%. Protocol adherence was achieved with patients receiving > 80% of the interventions. Overall mean (SD) daily Sedation Intensity Score was 52.4 (30.3) with a mean (SD) sedation frequency of 9.75 (7.21) PRN doses per day. There was a small but statistically significant decrease in heart rate at the beginning of the music intervention. There were no study related adverse events. Eighty-eight percent of the parents thought the headphones were comfortable; 73% described their child more settled during the intervention. Conclusions This pilot RCT has demonstrated the feasibility of a music medicine intervention in critically ill children. The study has also provided the necessary information to plan a larger trial.

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O014 / #296: MUSIC USE FOR SEDATION IN CRITICALLY ILL CHILDREN (MUSICC TRIAL): A PILOT RANDOMIZED CONTROLLED TRIAL

Pediatric Critical Care Medicine ◽

10.1097/01.pcc.0000738164.47166.a6 ◽

2021 ◽

Vol 22 (Supplement 1 3S) ◽

pp. 9-10

Author(s):

G. García Guerra ◽

A. Joffe ◽

C. Sheppard ◽

K. Hewson ◽

I. Dinu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critically Ill ◽

Controlled Trial ◽

Critically Ill Children ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

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Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial

Trials ◽

10.1186/s13063-020-04533-6 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Atsushi Kawaguchi ◽

Gabrielle Bernier ◽

Jacques Lacroix ◽

Saly El Salti ◽

Matthew P. Cheng ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Critically Ill ◽

Study Protocol ◽

Controlled Trial ◽

Critically Ill Children ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

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The Influence of Connectedness to Nature on Psychological Well-Being: Evidence from the Randomized Controlled Trial Play&Grow

Challenges ◽

10.3390/challe12010012 ◽

2021 ◽

Vol 12 (1) ◽

pp. 12

Author(s):

Tanja Sobko ◽

Gavin T. L. Brown

Keyword(s):

Randomized Controlled Trial ◽

Young Children ◽

Psychological Health ◽

Mental Health Problems ◽

Controlled Trial ◽

Well Being ◽

Path Model ◽

Psychological Well Being ◽

Connectedness To Nature ◽

Randomized Controlled

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.

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