Diabetic Polyneuropathy
Conditions
Brief summary
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.
Interventions
Virtual Reality application with a VR goggle
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 70 years old * Able to speak Dutch/French * Continuing usual care regarding medication use 3 weeks prior and during study participation * Diagnosis of DPN for 6 months or longer, confirmed on EMG
Exclusion criteria
* History of seizures/epilepsia * Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia * shift workers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep efficiency between experimental and control intervention. | Evaluated during two time periods of two weeks. | Measured with actigraphy. |
| Change in number of awakenings during the night between experimental and control intervention. | Evaluated during two time periods of two weeks. | Measured with actigraphy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain catastrophizing | Evaluated at the end of the experimental and control intervention namely after the two-week periods. | Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing. |
| Anxiety and depressive symptoms | Evaluated at the end of the experimental and control intervention namely after the two-week periods. | Measured with the Hospital Anxiety and Depression Scale |
| Change in subjective sleep quality between experimental and control intervention. | Evaluated during two time periods of two weeks. | Measured with the Pittsburgh Sleep Quality Index (ranging from 0-21 with higher scores a poorer sleep quality). |
| 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 | Evaluated at the end of the experimental and control intervention namely after the two-week periods. | Measured with the Insomnia Severity Index |
| Change in clinical status | Evaluated at the end of the experimental and control intervention namely after the two-week periods. | Measured with the Global perceived effect |
| Change in pain intensity reporting between experimental and control intervention. | Evaluated during two time periods of two weeks. | Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity. |
Countries
Belgium
Outcome results
None listed