The RELAX TO SLEEP Study

The Hospital for Sick Children

Status: Completed

Conditions: Sleep

Treatments: Behavioral: Relax To Sleep Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01734148

10000 26217

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children between the ages of 4 and 10.
2. Children expected to stay for 3 nights.
3. Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
4. Child must be in a single private room.

Exclusion criteria

1. Children who are receiving palliative care only during their hospital admission.
2. Children diagnosed with a sleep disorder or a clinical anxiety disorder.
3. 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.
4. Children who are too acutely ill to participate in the study.
5. Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
6. Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Experimental group (RELAX TO SLEEP program)

Experimental group

Treatment:

Behavioral: Relax To Sleep Program

Control group (Usual Care)

No Intervention group