VR in Diabetic Polyneuropathy

Universitair Ziekenhuis Brussel8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Polyneuropathy

Interventions

Virtual Reality applicationOTHER

Virtual Reality application with a VR goggle

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Brussel

Jette, Belgium

Outcomes

Primary Outcomes

Change in sleep efficiency between experimental and control intervention.

Measured with actigraphy.

Time frame: Evaluated during two time periods of two weeks.

Change in number of awakenings during the night between experimental and control intervention.

Measured with actigraphy.

Time frame: Evaluated during two time periods of two weeks.

Secondary Outcomes

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).

Time frame: Evaluated during two time periods of two weeks.

Change in pain intensity reporting between experimental and control intervention.

Measured with Visual Analogue Scale pain diary, whereby higher scores indicate hisger pain intensity.

Time frame: Evaluated during two time periods of two weeks.

Pain catastrophizing

Measured with the Pain Catastrophizing Scale whereby higher score are indicative for more catastrophizing.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.