The RELAX TO SLEEP Study
Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Although sleep interventions exist for healthy children in the community, interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons will be made to examine sleep outcomes between the intervention group and the control group including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety levels and the development of post-hospital maladaptive behaviours.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial|
- Total nocturnal sleep at hospital [ Time Frame: total measured over 3 days and 3 nights ] [ Designated as safety issue: No ]Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
- Anxiety [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]Anxiety will be measured using the Spence Pre-school anxiety scale for children 4 to 5 years of age , and the Spence Children's Anxiety Scale (SCAS) for children ages 6-10
- Post-hospital maladaptive behaviours [ Time Frame: Follow-up (5-7 days post discharge) ] [ Designated as safety issue: No ]member of the research team will make contact within 5-7 days post-discharge by telephone and ask them to complete the Post-Hospital Behaviour Questionnaire (PHBQ), a self-report questionnaire for parents most commonly used for assessing children's post-hospital behaviour
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Group A - Experimental group (RELAX TO SLEEP program)||
Behavioral: Relax To Sleep Program
The Relax to Sleep program consists of a standardized educational booklet with a discussion with the PI and a relaxation breathing technique for the child. The educational portion of the program will consist of a standardized educational booklet and a discussion with the PI and provides a brief overview will be given on normal sleep and sleep patterns, children's sleep needs, and the signs and consequences of sleep disturbance. Second, the educational booklet provides sleep hygiene info. The second component consists of of good sleep habits such as having a regular sleep-wake schedule, avoiding caffeine intake prior to sleep, avoiding stimulating activities near nighttime sleep, avoidance of naps during the day, ensuring that the child is exposed to natural light during the day, providing the child with opportunities to socialize during the day. Finally, the program consists of aa relaxation breathing technique for the child.
|No Intervention: Group B - Control group (Usual Care)|
|Contact: Efrosini Papaconstantinoufirstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5V1X8|
|Principal Investigator: Robyn Stremler, RN, PhD|
|Sub-Investigator: Efrosini Papaconstantinou, RN, MSc, PhD Candidate|
|Principal Investigator:||Robyn Stremler||The Hospital for Sick Children|