itch Pruritus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults (aged 18-80 years) with chronic itch of any origin for at least 1 year prior to inclusion in this study, who have been seen by a physician for the itch. Itch symptoms lead to psychological and/or functional impairment despite standard medical treatment. Patients should speak and understand Dutch and be able to complete questionnaires.
Exclusion criteria
Exclusion criteria: (history of) severe psychiatric comorbidities irrelated to their itch condition such as psychosis or severe clinical depression or anxiety disorder (anxiety and depressive symptoms in itself are common in individuals with chronic symptoms and therefore no reason for exclusion); history of seizures; history of severe migraine; high susceptibility to motion sickness; balance problems; face, head, or neck injury; visual or audiological impairment; pacemaker, defibrillator or other electronic (implantable) device of vital importance; pregnancy or when lactating, and participation in another interventional itch study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will be conducted to assess whether a VRH intervention is a useful technique (compared to a waiting list control group) (with clinically relevant effect) for short-term (during and at end of treatment) and longer-term (approximately 6 weeks post-treatment) itch reduction in terms of clinical itch intensity (0-10 NRS) [various time points during and after treatment compared to baseline]. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will furthermore be conducted to assess whether VRH intervention is a useful technique (compared to a waiting list control group) (with clinically relevant effect) in terms of (a) the impact of the itch and overall wellbeing (Impact of Skin Disease on Daily Life (ISDL) scales for skin status, physical symptoms, scratching, impact of illness, psychological functioning and illness cognitions; and the Hospital Anxiety and Depression Scale (HADS)), (b) medical treatment need (type of drug/treatment x quantification), and (c) itch sensitivity (upon application of cowhage) [end of treatment and follow-up compared to baseline]. Finally, the study will be conducted to assess the extent to which treatment confidence, hypnotic susceptibility, and perceived presence in the VR environment correlate with the difference in clinical itch intensity at the end of treatment and at follow-up compared to with baseline. | — |
Countries
Netherlands