Pediatric OncologySLEEPNCT06587815
The Impact of a Musical Starry Sky Projector on Fatigue, Sleep, and Quality of Life in Pediatric Oncology Patients
A study testing musical starry sky projector in people with Pediatric Oncology and Sleep Problems, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Oncology, Sleep Problems, Fatigue Intensity
- What is being tested?
- musical starry sky projector
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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
- Pediatric Oncology, Sleep Problems, Fatigue Intensity, Quality of Life
- Being tested
- musical starry sky projector
- Keywords
- fatigue, pediatric oncology, sleep, quality of life
- Medical subject headings
- Parasomnias, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musical starry sky projectorOther
Children in intervention group received musical starry sky projector during their sleep time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: musical starry sky projector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: It will be evaluated every before the study and at the end of the first month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jul 2023
- Primary completion1 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Remziye Semerci, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587815
- Sponsor's protocol ID
- KOC UNI
- Acronym
- SLEEP
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06587815
- Acronym / sponsor ID
- SLEEP / KOC UNI
- Conditions
- Pediatric Oncology, Sleep Problems, Fatigue Intensity, Quality of Life
- Keywords
- fatigue, pediatric oncology, sleep, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Children in the control group were received standard care of the clinic |
| Intervention Group | Experimental | Other: musical starry sky projectorChildren in the intervention group received musical starry sky projector during the sleep time. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musical starry sky projectorChildren in intervention group received musical starry sky projector during their sleep time | Other | Intervention Group |
Primary outcome
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musical starry sky projector in people with Pediatric Oncology and Sleep Problems, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Intensity Scale Score (time frame: It will be evaluated every day for one month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.