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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Sleep Quality [Time frame: 3 months]

Secondary outcome measures (1)

• Overall Quality of Life [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Hong Kong · 1 center

• Hong Kong Children's Hospital — Kowloon Bay

Publications

• Zupanec S, Jones H, McRae L, Papaconstantinou E, Weston J, Stremler R. A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial. Cancer Nurs. 2017 Nov/Dec;40(6):488-496. doi: 10.1097/NCC.0000000000000457. PMID 27922922
• Zaccaro A, Piarulli A, Laurino M, Garbella E, Menicucci D, Neri B, Gemignani A. How Breath-Control Can Change Your Life: A Systematic Review on Psycho-Physiological Correlates of Slow Breathing. Front Hum Neurosci. 2018 Sep 7;12:353. doi: 10.3389/fnhum.2018.00353. eCollection 2018. PMID 30245619
• Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13. PMID 25679070
• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664. PMID 34812790
• Tanriverdi M, Cakir E, Akkoyunlu ME, Cakir FB. Effect of virtual reality-based exercise intervention on sleep quality in children with acute lymphoblastic leukemia and healthy siblings: A randomized controlled trial. Palliat Support Care. 2022 Aug;20(4):455-461. doi: 10.1017/S1478951522000268. PMID 35289266
• Sriasih NK, Allenidekania, Wanda D. The Effects of the COMMASH-E Intervention on the Fatigue, Sleep Quality and Functional Status of Children with Cancer in Indonesia. Compr Child Adolesc Nurs. 2019;42(sup1):197-207. doi: 10.1080/24694193.2019.1594451. PMID 31192716
• Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53. PMID 3332317
• Sari E, Gundogdu F, Semerci R. The Effect of Progressive Muscle Relaxation Exercises on Sleep Quality in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Study. Semin Oncol Nurs. 2024 Apr;40(2):151620. doi: 10.1016/j.soncn.2024.151620. Epub 2024 Mar 16. PMID 38494385

Identifiers

NCT: NCT07323069 · PAED-2025-074

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗