The RELAX TO SLEEP Study

The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Relax To Sleep Program

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total nocturnal sleep at hospital	Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.	total measured over 3 days and 3 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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	Baseline, Day 5
Post-hospital maladaptive behaviours	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	Follow-up (5-7 days post discharge)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Robyn Stremler, The Hospital for Sick Children

Publications and helpful links

General Publications

• Papaconstantinou EA, Hodnett E, Stremler R. A Behavioral-Educational Intervention to Promote Pediatric Sleep During Hospitalization: A Pilot Randomized Controlled Trial. Behav Sleep Med. 2018 Jul-Aug;16(4):356-370. doi: 10.1080/15402002.2016.1228639. Epub 2016 Sep 15.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pediatric; sleep difficulties in children; Sleep Education
• Other Study ID Numbers: 10000 26217