Status:
COMPLETED
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Sleep
Fatigue
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief Summary
This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children with a diagnosis of...
Detailed Description
Sleep is an essential restorative function that promotes both physical and cognitive health. Previous studies have demonstrated that children on Acute Lymphoblastic Leukemia (ALL) maintenance therapy ...
Eligibility Criteria
Inclusion
- Child aged 4-10 with a diagnosis of precursor acute B lymphoblastic leukemia (B ALL) in maintenance phase of therapy beyond 3rd course (protocol AALL0331)
- Child and parent able to understand and read English
- Child is within one year of age-appropriate grade in school
Exclusion
- Child who is receiving palliative care
- Child with diagnosis of depression
- Child who has been prescribed medications for insomnia
- Child who has a physician-diagnosed sleep disorder (e.g. narcolepsy, restless legs syndrome)
- Child who has received radiation therapy
- Child has potential sleep disordered breathing (measured by Children's Sleep Habits Questionnaire)
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02295839
Start Date
May 1 2011
End Date
August 1 2014
Last Update
September 13 2019
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8