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

December 30, 2025 updated by: Mak Shuk Yan, Chinese University of Hong Kong

The Dreamcatchers Programme - A Nurse-led Multicomponent Interventional Protocol to Improve Sleep Quality in Paediatric Oncology Patients: A Pilot Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Kowloon Bay, Hong Kong
        • Recruiting
        • Hong Kong Children's Hospital
        • Contact:
        • Principal Investigator:
          • Shuk Yan Mak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education with Exercises
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.
Other: Sleep Hygiene Education
The 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.
Other: Progressive Muscle Relaxation

Following 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.

Other: Breathing exercises
Breathing 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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Quality of Life
Time Frame: 3 months
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Hong Kong Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAED-2025-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Some participants do not wish to share their information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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