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

NCT06587815 | Completed

• 1 other identifier: KOC UNI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Oncology; Sleep Problems; Fatigue Intensity; Quality of Life

Keywords

fatigue, pediatric oncology, sleep, quality of life

Outcome Measures

Primary Outcomes (3)

• Fatigue Intensity Scale Score

  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).

  It will be evaluated every day for one month.

• Visual Sleep Scale Score

  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.

  It will be evaluated every day for one month.

• Pediatric Quality of Life Inventory (PedsQL) Score

  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.

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

Study Arms (2)

Control Group

NO INTERVENTION

Children in the control group were received standard care of the clinic

Intervention Group

EXPERIMENTAL

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

Other: musical starry sky projector

Interventions

musical starry sky projector OTHER

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

Intervention Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead
• Koç University: collaborator

Study Sites (1)

Koç University

Istanbul, Fatih, 34104, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Fatigue

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)