About this trial
Sleep is essential for a child's development, influencing cognitive function, emotional stability, recovery, and overall well-being. Prolonged and intensive treatments for pediatric oncology patients can lead to sleep disturbances that are often overlooked by caregivers and healthcare professionals as temporary side effects. Symptoms may include difficulty initiating or maintaining sleep, reduced sleep duration, or perceived poor sleep quality. Recent studies indicate that sleep disturbances affect between 13% to 50% of leukemia survivors and up to 80% of children with central nervous system tumors. A recent study in Hong Kong found that approximately 45% of pediatric oncology survivors continue to face sleep challenges, underscoring the global and local relevance of this issue.
These sleep disturbances in this vulnerable group often result from factors such as pain and nausea due to chemotherapy side effects, which can be exacerbated by corticosteroids. The immediate discomfort caused by sleep disruptions can significantly affect treatment adherence, daily activities, social interactions, and overall quality of life.
While pharmacological approaches remain the standard treatment for pediatric sleep disturbances, this method carries significant risks, including potential drug interactions and dependence. Non-pharmacological options, however, empower patients and caregivers to manage sleep issues without increasing medication use, promoting a proactive approach to sleep health.
In response to the need to enhance sleep quality among pediatric oncology patients, the Dreamcatchers Programme was developed as a nurse-led initiative. This program focuses on relaxation and offers sustainable strategies for improved sleep through sleep hygiene practices, progressive muscle relaxation (PMR), and breathing exercises for both patients and caregivers. Evidence-based interventions equip nurses with holistic techniques that address gaps in their knowledge and skills.
This project proposal details a randomized controlled pilot study aimed at evaluating the feasibility and preliminary effectiveness of the Dreamcatchers Programme, setting the groundwork for a standardized sleep management protocol in pediatric oncology care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children who can read and communicate in Chinese
Aged 6 to 12 years old (school-aged children).
Diagnosed with cancer and currently undergoing active treatment.
Identified as experiencing sleep disturbances, defined by a Chinese Pittsburgh Sleep Quality Index (PSQI) global score of ≥5.
Disqualifiers
Diagnosed with hematological diseases unrelated to cancer (e.g., sickle cell anemia, thalassemia).
Presence of severe cognitive impairment, which may hinder the ability to follow instructions or engage with intervention components.
Trial design
Parallel
Treatments tested in this trial
Sleep Hygiene Education
Other interventionThe first part of the intervention consists of a group education session on sleep hygiene. Each session will accommodate a maximum of 10 participants and will last approximately 45 minutes facilitated by a nurse using a PowerPoint presentation.
Progressive Muscle Relaxation
Other interventionFollowing the education session, practical demonstrations of PMR will be conducted, allowing patients and caregivers to practice what they have learned. These exercises will be designed to be simple, age-appropriate, and easily integrated into daily routines. PMR helps lower stress and anxiety by modulating the activities of the autonomic nervous system. The entire PMR routine will take approximately 10-15 minutes, consistent with the duration of relaxation exercises noted in earlier research.
Breathing exercises
Other interventionBreathing exercises will also be demonstrated and advised to be used before bedtime, aiming to reduce physiological arousal and promote relaxation through slowing down breathing rate, amplifying vagus nerve activity and normalizing stress responses. The breathing routine, incorporating box breathing techniques, will last 5-10 minutes and is to be practiced as part of the children's wind-down routine before sleep.
Treatment groups
Trial outcomes
Primary outcomes
Sleep Quality
The primary outcome focuses on improvements in sleep quality among pediatric oncology patients aged 6-12 years, as measured by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). PSQI score is a number from 0-21, with 0 being best and higher scores indicating worse sleep; a score over 5 suggests significant sleep problems.
Secondary outcomes
Overall Quality of Life
The secondary outcome focuses on enhancing the overall quality of life of participating children during active cancer treatment, as measured by the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module 3.0. PedsQL score ranges from 0-100, and higher PedsQL scores indicate better quality of life.
Other outcomes
Acceptability
Additionally, the study evaluates acceptability of the programme which is assessed through a custom-designed satisfaction survey (with Likert-scale and open-ended questions) and semi-structured interviews conducted with the intervention group at T1.
Sponsors and contacts
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Chinese University of Hong Kong
Lead sponsor
Hong Kong Children's Hospital
Collaborator