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Completed

NCT Number: NCT01734148

The RELAX TO SLEEP Study

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.

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Key information

Conditions

Sleep

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between the ages of 4 and 10.
  • 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.

Treatment and study plan

Relax To Sleep Program

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 27, 2012
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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