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| Name | Class |
|---|---|
| Koç University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| musical starry sky projector | Other | Children in intervention group received musical starry sky projector during their sleep time |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University | Istanbul | Fatih | 34104 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |