VR in Diabetic Polyneuropathy

Not Applicable

Completed

• Conditions: Diabetic Polyneuropathy
• Interventions: Other: Virtual Reality application

• Registration Number: NCT04325347
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2021-01-27
• Primary Completion: 2023-06-26
• Study Completion: 2023-07-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual Reality application	Virtual Reality will be provided to all participants, just before sleeping.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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 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.
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 clinical status	Evaluated at the end of the experimental and control intervention namely after the two-week periods.	Measured with the Global perceived effect

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium