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

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.

Condition or disease Intervention/treatment Phase
Sleep Behavioral: Relax To Sleep Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
Study Start Date : September 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Robyn Stremler, Nursing Research Associate, The Hospital for Sick Children Identifier: NCT01734148     History of Changes
Other Study ID Numbers: 10000 26217
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Robyn Stremler, The Hospital for Sick Children:
sleep difficulties in children
Sleep Education