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

NCT07323069 | Recruiting

• 1 other identifier: PAED-2025-074
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatrics Cancer

Keywords

pediatrics; oncology; leukemia; solid tumour; sleep; sleep quality; quality of life; sleep disturbances

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Overall Quality of Life

  3 months

Other Outcomes (1)

• Acceptability

  1 month

Study Arms (2)

Education with Exercises

EXPERIMENTAL

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; Other: Progressive Muscle Relaxation; Other: Breathing exercises

Control

NO INTERVENTION

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.

Interventions

Progressive Muscle Relaxation OTHER

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.

Education with Exercises

Sleep Hygiene Education OTHER

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.

Education with Exercises

Breathing exercises OTHER

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.

Education with Exercises

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Children's Hospital: collaborator

Study Sites (1)

Hong Kong Children's Hospital

Kowloon Bay, Hong Kong

RECRUITING

Related Publications (17)

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  BACKGROUND

• Blackwell CK, Hartstein LE, Elliott AJ, Forrest CB, Ganiban J, Hunt KJ, Camargo CA Jr, LeBourgeois MK; program collaborators for Environmental influences on Child Health Outcomes (ECHO). Better sleep, better life? How sleep quality influences children's life satisfaction. Qual Life Res. 2020 Sep;29(9):2465-2474. doi: 10.1007/s11136-020-02491-9. Epub 2020 May 12.

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MeSH Terms

Conditions

Neoplasms; Leukemia; Sleep Initiation and Maintenance Disorders; Parasomnias

Interventions

Autogenic Training; Breathing Exercises

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Shuk Yan Mak

CONTACT

+852 62229509; nafertes@gmail.com

William Li

CONTACT

+852 39430889; williamli@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Ward Manager (Paediatrics and Adolescent Medicine)

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 7, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)