The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Total nocturnal sleep at hospital
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children between the ages of 4 and
- •Children expected to stay for 3 nights.
- •Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
- •Child must be in a single private room.
Exclusion Criteria
- •Children who are receiving palliative care only during their hospital admission.
- •Children diagnosed with a sleep disorder or a clinical anxiety disorder.
- •Children with limited or abnormal movements of both upper and lower extremities (e.g. paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis, musculoskeletal impairments, use of restraints, under heavy sedation), thereby impairing sleep wake activity recording and the inability to use the relaxation breathing exercise.
- •Children who are too acutely ill to participate in the study.
- •Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
- •Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.
Arms & Interventions
Control group (Usual Care)
Experimental group (RELAX TO SLEEP program)
Intervention: Relax To Sleep Program (Behavioral)
Outcomes
Primary Outcomes
Total nocturnal sleep at hospital
Time Frame: total measured over 3 days and 3 nights
Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
Secondary Outcomes
- Anxiety(Baseline, Day 5)
- Post-hospital maladaptive behaviours(Follow-up (5-7 days post discharge))
Investigators
Robyn Stremler
Nursing Research Associate
The Hospital for Sick Children