The RELAX TO SLEEP Study
This study is currently recruiting participants.
Verified November 2012 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01734148
First received: November 21, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
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Purpose
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 |
|---|---|
|
Sleep |
Behavioral: Relax To Sleep Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 46 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A - Experimental group (RELAX TO SLEEP program) |
Behavioral: Relax To Sleep Program
The Relax to Sleep program consists of a standardized educational booklet with a discussion with the PI and a relaxation breathing technique for the child. 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 aa relaxation breathing technique for the child.
|
| No Intervention: Group B - Control group (Usual Care) |
Eligibility| Ages Eligible for Study: | 4 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734148
Contacts
| Contact: Efrosini Papaconstantinou | efrosini.papaconstantinou@mail.utoronto.ca |
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5V1X8 | |
| Principal Investigator: Robyn Stremler, RN, PhD | |
| Sub-Investigator: Efrosini Papaconstantinou, RN, MSc, PhD Candidate | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Robyn Stremler | The Hospital for Sick Children |
More Information
No publications provided
| Responsible Party: | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT01734148 History of Changes |
| Other Study ID Numbers: | 10000 26217 |
| Study First Received: | November 21, 2012 |
| Last Updated: | November 21, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by The Hospital for Sick Children:
|
pediatric sleep difficulties in children Sleep Education |
ClinicalTrials.gov processed this record on May 21, 2013