The effectiveness of virtual reality-assisted hypnosis in reducing itch: a proof-of-concept study

Conditions: itch
Pruritus
10014982

Registration Number: NL-OMON56407

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

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

(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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study will be conducted to assess whether a VRH intervention is a useful<br /><br>technique (compared to a waiting list control group) (with clinically relevant<br /><br>effect) for short-term (during and at end of treatment) and longer-term<br /><br>(approximately 6 weeks post-treatment) itch reduction in terms of clinical itch<br /><br>intensity (0-10 NRS) [various time points during and after treatment compared<br /><br>to baseline].</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The study will furthermore be conducted to assess whether VRH intervention is a<br />useful technique (compared to a waiting list control group) (with clinically<br />relevant effect) in terms of (a) the impact of the itch and overall wellbeing<br />(Impact of Skin Disease on Daily Life (ISDL) scales for skin status, physical<br />symptoms, scratching, impact of illness, psychological functioning and illness<br />cognitions; and the Hospital Anxiety and Depression Scale (HADS)), (b) medical<br />treatment need (type of drug/treatment x quantification), and (c) itch<br />sensitivity (upon application of cowhage) [end of treatment and follow-up<br />compared to baseline].<br /><br />Finally, the study will be conducted to assess the extent to which treatment<br />confidence, hypnotic susceptibility, and perceived presence in the VR<br />environment correlate with the difference in clinical itch intensity at the end<br />of treatment and at follow-up compared to with baseline.</p>