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This study is an experimental single centre study investigating the effect of VR on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Virtual Reality will be provided to all participants, just before sleeping. |
|
| Control | No Intervention | No specific intervention will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality application | Other | Virtual Reality application with a VR goggle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep efficiency between experimental and control intervention. | Measured with actigraphy. | Evaluated during two time periods of two weeks. |
| Change in number of awakenings during the night between experimental and control intervention. | Measured with actigraphy. | Evaluated during two time periods of two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective sleep quality between experimental and control intervention. | Measured with the Pittsburgh Sleep Quality Index (ranging from 0-21 with higher scores a poorer sleep quality). | Evaluated during two time periods of two weeks. |
| Change in pain intensity reporting between experimental and control intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | 1090 | Belgium |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity. |
| Evaluated during two time periods of two weeks. |
| Pain catastrophizing | Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing. | Evaluated at the end of the experimental and control intervention namely after the two-week periods. |
| Anxiety and depressive symptoms | Measured with the Hospital Anxiety and Depression Scale | Evaluated at the end of the experimental and control intervention namely after the two-week periods. |
| Change in clinical status | Measured with the Global perceived effect | Evaluated at the end of the experimental and control intervention namely after the two-week periods. |
| Any side effects of the experimental intervention | Evaluated at the end of the experimental intervention namely after the two-week period. |
| Nature, severity and impact of insomnia | Measured with the Insomnia Severity Index | Evaluated at the end of the experimental and control intervention namely after the two-week periods. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |