The RELAX TO SLEEP Study

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Behavioral: Relax To Sleep Program

• Registration Number: NCT01734148
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-08
• Study Completion: 2012-10
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (RELAX TO SLEEP program)	Relax To Sleep Program	-

Primary Outcome Measures

Name	Time	Method
Total nocturnal sleep at hospital	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

Name	Time	Method
Anxiety	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	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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada