The Feasibility and Acceptability of a Behavioral-educational Intervention - the Relax to Sleep Program - to Increase Pediatric Sleep during Hospitalization: A Pilot Randomized Controlled Trial

Background: Hospitalization can contribute to common sleep difficulties related to environmental, physiological, and psychological factors. Interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study was to examine the feasibility and acceptability of a behavioral-educational intervention - the RELAX TO SLEEP program - aimed at increasing nighttime sleep for hospitalized children. Methods: This study was a pilot randomized controlled trial. Children between the ages of 4 and 10 years, expected to stay for 3 nights in hospital, with a parent staying overnight were included. Children were excluded if they were receiving palliative care; were diagnosed with a sleep or anxiety disorder; had limited movements of extremities or had cognitive impairment; or received sedation. Forty-eight children and their caregivers consented and were randomized to either the RELAX TO SLEEP intervention group (n=24) or the Usual Care control group (n=24). The RELAX TO SLEEP program consisted of a one-on-one discussion with the researcher about sleep and sleep hygiene, a standardized educational booklet about sleep, and a relaxation breathing (RB) exercise for the child. Usual Care participants received no information about sleep or relaxation. Children wore actigraphs for 3 days and nights and completed sleep diaries. Sleep outcomes included: total nocturnal sleep (19h30-07h29), number of nighttime awakenings, longest period of uninterrupted nocturnal sleep, and total daytime (07h30-19h29) sleep. Other outcomes measured at baseline and at 7 days post-discharge, included anxiety (Spence Pre-school/Children Anxiety Subscales), sleep habits (Children's Sleep Habits Questionnaire [CSHQ]), and post-hospital maladaptive behaviours (Post-Hospital Behaviour Questionnaire [PHBQ]). Results: Of the 68 eligible families approached, 71% (n=48) agreed to participate. Both the RELAX TO SLEEP and Usual Care group were compliant in wearing the actigraph and completing sleep diaries. Eighty-five per cent (n=19/22) of the Relax to Sleep participants reported using the RB at least once per day in hospital, and over half used it 2-3 times per day. Parental reports indicated that their child enjoyed using RB (18/22; 82%), that it was easy to use (21/22; 95%), and would use it again in the future (18/22; 82%). Parents also reported that they enjoyed the discussion about sleep and found the information helpful (21/22; 95%). Children in the RELAX TO SLEEP group obtained a mean of 50 minutes more nighttime sleep compared to the UC group (419 Âą 7.84 min vs. 369.7 Âą 106.4 min, group difference 49.64 min, t= 1.76, p=0.085), despite having the same number of nighttime awakenings (14.7 [SD 5.83) and 14.7 [SD 4.7] respectively). Improved CSHQ scores at follow-up were noted for the RELAX TO SLEEP group (baseline score 44.04 [SD 7.17] to follow-up 42.38 [SD 5.41]) compared to the increase in sleep disturbance behaviour noted in the Usual Care group (baseline score 45.58 [7.82] to follow-up 47.52 [7.47]). There were no notable differences in anxiety or PHBQ scores; however, the majority of children in this sample (73%, n=32/44) scored 81 or higher on the PHBQ indicating the development of at least one new-onset maladaptive behaviour during the post-discharge period. Conclusion: The RELAX TO SLEEP program proposed in this study was feasible and acceptable to children and their caregivers. Further evaluation of the intervention with a large scale, multicenter RCT is needed.

Keywords: hospitalization
intervention
pediatrics
randomized controlled trial
sleep
Advisor: Robyn, Stremler