A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Pediatrics Cancer

Treatments: Other: Progressive Muscle Relaxation; Other: Sleep Hygiene Education; Other: Breathing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07323069

PAED-2025-074

Details and patient eligibility

About

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.

Full description

The trial employs a prospective, single-blind, waitlist-controlled design with 1:1 allocation. Block randomization, generated by computer and concealed in sealed opaque envelopes, ensures balanced group sizes and minimizes selection and allocation bias. Blinding of participants and caregivers is infeasible due to the intervention's nature, but outcome assessors (nurses collecting data) remain blinded to group assignment to reduce observer bias.

To prevent contamination, intervention sessions occur in a separate educational room away from clinical areas. Access to supportive QR code videos of relaxation exercises is password-protected and restricted to the intervention group.

Recruitment uses simple random sampling from a computer-generated list of eligible attendees at the ambulatory chemotherapy day center of Hong Kong Children's Hospital (HKCH). Day patients are selected over inpatients for their stable attendance patterns, which support consistent intervention delivery, follow-up, and data collection. This choice enhances feasibility, aligns with the programme's intended home-based application, minimizes hospital-related confounders (e.g., interruptions, equipment), and improves generalizability to outpatient and survivorship settings.

The principal investigator approaches eligible families, obtains informed consent from caregivers, and assent from children where appropriate, reducing selection bias.

Sample size follows methodological guidance emphasizing logistical and feasibility assessments over powered hypothesis testing.

This multi-component, nurse-delivered programme targets sleep hygiene, progressive muscle relaxation (PMR), and breathing exercises.

Initial Group Education Session (~45 minutes, max 10 participants/caregivers): Nurse-facilitated PowerPoint covers sleep's role in recovery, optimal sleep environment (lighting, noise), consistent routines, screen-free alternatives, diaphragmatic breathing/PMR for relaxation, and sleep diary use (booklet for tracking habits, duration, and exercises).

Practical Demonstrations: Hands-on practice of PMR (10-15 minutes; gentle, suitable for reduced mobility/strength) and box breathing (5-10 minutes; pre-bedtime to reduce arousal via vagal stimulation).

Support Materials: QR code access to video recordings of exercises (adapted from established resources).

Weekly Follow-ups (4 weeks): Reinforcement, practice, troubleshooting, and monitoring of adherence/sleep hygiene.

Waitlist participants receive routine hospital support and general pediatric oncology education (e.g., neutropenic diet), maintaining engagement without sleep-specific content.

De-identified data (unique codes) are stored securely (password-protected files, locked physical records) per Hospital Authority policies, retained 5 years post-study, then destroyed. Incidental severe findings prompt notification while maintaining confidentiality.

Enrollment: 68 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Education with Exercises

Experimental group

Description:

The intervention group will receive the Dreamcatchers Programme, including sleep hygiene education, PMR, and breathing control exercises, which will be delivered over 4 weeks with weekly in-person follow-ups.

Treatment:

Other: Breathing exercises

Other: Sleep Hygiene Education

Other: Progressive Muscle Relaxation

Control

No Intervention group

Description:

The waitlist control group will continue to receive routine hospital support and pediatric oncology health information (e.g., neutropenic diet tips) to maintain engagement without sleep-specific strategies. In order to ensure fairness, participants of the waitlist control group will be given access to the Dreamcatchers Programme once the final follow-up assessment is completed.