Feasibility, Acceptability, and Effectiveness of a Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy for Acute Lymphoblastic Leukemia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sleep
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep.
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 have problematic sleep patterns and experience fatigue. This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children aged 4-10, with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep. Sleep tips were evaluated by intervention group families.
Investigators
Sue Zupanec
Nurse Practitioner
The Hospital for Sick Children
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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)
Outcomes
Primary Outcomes
Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
Time Frame: Weeks 1-4, post-intervention
The Evaluation of Sleep Tips form will use open-ended questions to ask parents about factors that promoted or prevented implementing the sleep hygiene and relaxation interventions, and which components of the intervention they implemented and in what frequency.
Secondary Outcomes
- Nocturnal sleep (minutes)(Five consecutive nights on two occasions)