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NCT Number: NCT06587815

The Impact of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients

This study evaluated the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep, and quality of life in pediatric oncology patients.

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Key information

Conditions

Pediatric Oncology Fatigue Fatigue Intensity Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Sleep Problems Sleep Wake Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, Fatih, 34104, Turkey (Türkiye)

About this study

Sleep disturbances and fatigue were common issues among pediatric oncology patients, significantly impacting their overall quality of life. This study aimed to evaluate the effect of an Ocean Wave and LED Starry Sky Projector on fatigue, sleep patterns, and quality of life in this patient population. The research was structured as a parallel-group, randomized controlled trial. Pediatric oncology patients, aged 8-18 years, were recruited for participation.

The study intervention group used the Ocean Wave and LED Starry Sky Projector each night for one month, along with receiving the standard care typically provided in the oncology unit. The projector created a soothing visual and auditory environment designed to help induce relaxation, potentially improving sleep and reducing fatigue. Meanwhile, the control group received only the standard care offered to pediatric oncology patients, without the addition of the projector intervention. This study offered valuable insights into the use of non-pharmacological interventions for improving sleep quality and reducing fatigue among pediatric oncology patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric oncology patients aged 8-18 years.
  • Recently diagnosed (< 1 month).
  • Active receiving chemotherapy treatment
  • Able to read and write in Turkish.
  • Willing to participate voluntarily.

Exclusion criteria

  • Being at the end of life
  • Diagnosed with mental problems.
  • Haemoglobin levels below 7 mg/dL).
  • Having visual or hearing impairments.
  • Unable to understand or communicate in Turkish.

Treatment and study plan

musical starry sky projector

Other

Children in intervention group received musical starry sky projector during their sleep time

Primary outcomes

  1. Fatigue Intensity Scale Score

    Time frame: It will be evaluated every day for one month.

    The FIS is an instrument developed to measure fatigue levels by Borneman et al., 2007. A single-item scale was created to measure fatigue intensity, rated on a scale from 0 to 10, where 0 represents no fatigue and 10 represents severe, overwhelming fatigue. The scale demonstrates face and content validity, with strong concurrent validity when compared to the Revised Piper Fatigue Scale and robust criterion validity. The scale relies on self-reporting by the patient, allowing for an accurate reflection of their fatigue levels. This tool will be administered daily throughout the intervention to monitor changes in fatigue levels (Borneman et al., 2007).

  2. Visual Sleep Scale Score

    Time frame: It will be evaluated every day for one month.

    The primary outcome of this study will be to assess sleep quality and fatigue levels in pediatric oncology patients. The VSS is a visual tool designed to assess sleep quality in pediatric patients. The scale is scored from 1 to 10, with a higher score indicating poorer sleep quality. This scale offers a straightforward and intuitive method for evaluating the patient's perception of their sleep, making it suitable for use in a clinical setting.

  3. Pediatric Quality of Life Inventory (PedsQL) Score

    Time frame: It will be evaluated every before the study and at the end of the first month.

    The PedsQL will be administered at two critical time points: at the baseline of the intervention and after one month. It is a validated tool for measuring health-related quality of life in children aged 2-18. It includes 23 items across four domains: physical health, emotional functioning, and social functioning, as defined by the World Health Organization. Additionally, it evaluates school functioning. The PedsQL provides three primary scores: Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score, derived from the emotional, social, and school functioning domains.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Koç University

Registry information

Official study title

The Effect of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients: A Randomized Controlled Trial Protocol

Acronym: SLEEP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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