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This study has been completed.
Information provided by (Responsible Party):
Robyn Stremler, The Hospital for Sick Children Identifier:
First received: November 21, 2012
Last updated: November 17, 2014
Last verified: November 2014
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.

Condition Intervention
Behavioral: Relax To Sleep Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 48
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group (RELAX TO SLEEP program) 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.
No Intervention: Control group (Usual Care)


Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01734148

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Robyn Stremler The Hospital for Sick Children
  More Information

Responsible Party: Robyn Stremler, Nursing Research Associate, The Hospital for Sick Children Identifier: NCT01734148     History of Changes
Other Study ID Numbers: 10000 26217
Study First Received: November 21, 2012
Last Updated: November 17, 2014

Keywords provided by The Hospital for Sick Children:
sleep difficulties in children
Sleep Education processed this record on March 27, 2017