The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01734148
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Robyn Stremler, The Hospital for Sick Children

November 21, 2012
November 27, 2012
November 19, 2014
September 2011
August 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01734148 on Archive Site
  • Anxiety [ Time Frame: Baseline, Day 5 ]
    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) ]
    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
Same as current
Not Provided
Not Provided
The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Behavioral: Relax To Sleep Program
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 a relaxation breathing technique for the child.
  • Experimental: Experimental group (RELAX TO SLEEP program)
    Intervention: Behavioral: Relax To Sleep Program
  • No Intervention: Control group (Usual Care)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 10 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
10000 26217
Not Provided
Not Provided
Robyn Stremler, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Robyn Stremler The Hospital for Sick Children
The Hospital for Sick Children
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP