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

NCT ID: NCT06587815

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Oncology Sleep Problems Fatigue Intensity Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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

Group Type EXPERIMENTAL

musical starry sky projector

Intervention Type OTHER

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

Interventions

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musical starry sky projector

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koç University

OTHER

Sponsor Role collaborator

Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Remziye Semerci

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Koç University

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KOC UNI

Identifier Type: -

Identifier Source: org_study_id

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