NCT01734148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

November 21, 2012

Last Update Submit

September 11, 2019

Conditions

Sleep

Keywords

pediatricsleep difficulties in childrenSleep Education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Anxiety

    Baseline, Day 5

  • Post-hospital maladaptive behaviours

    Follow-up (5-7 days post discharge)

Study Arms (2)

Experimental group (RELAX TO SLEEP program)

EXPERIMENTAL
Behavioral: Relax To Sleep Program

Control group (Usual Care)

NO INTERVENTION

Interventions

Relax To Sleep ProgramBEHAVIORAL

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.

Experimental group (RELAX TO SLEEP program)

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 27633943RESULT

Study Officials

  • Robyn Stremler

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Research Associate

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 27, 2012

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

CA(1)