Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy (SHARI)

The Hospital for Sick Children

Status

Completed

Conditions

Acute Lymphoblastic Leukemia

Fatigue

Sleep

Treatments

Behavioral: Sleep Hygiene and Relaxation Education

Study type

Interventional

Funder types

Other

Identifiers

NCT02295839

1000025162

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

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)