About this trial
Chronic itch is a disabling condition with currently limited treatment options. Virtual reality (VR) is a relatively new approach that provides immersion in another environment and has been shown to have a temporary itch mitigating potential. Hypnosis, which is a state of relaxation, has been successfully applied with more long-term treatment effects in the specific case of itch as a result of severe atopic dermatitis. However, hypnosis tends to depend on an individual's susceptibility, or ease, to come into a hypnotic state. A combination of VR and hypnosis (VRH) has been put forward since it may combine the longer lasting effects of hypnosis with VR making the hypnosis more accessible by facilitating imagination. Even though VRH is a promising avenue, it has never been investigated in the context of itch. In this randomized controlled trial, comparing a VRH treatment with a waiting list control group after 6 sessions and at follow-up, it is aimed to assess the effectiveness of VRH in reducing itch along with its psychological burden in adult individuals with therapy-resistant disabling itch.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be adults (aged 18-80 years)
Participants must have been suffering from chronic pruritus of any origin for at least 1 year prior to inclusion in this study
Participants must have been seen by a physician for the itch
Participants must experience psychological and/or functional impairment due to the itch despite standard medical treatment.
Disqualifiers
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;
Severe susceptibility to motion sickness;
Trial design
Parallel
Treatments tested in this trial
Virtual Reality-assisted hypnosis
BehavioralThe VRH intervention consists of 6 interventional sessions. Every session, first, participants receive hypnotic induction and go through a deepening phase using a hypnotic script and a VR environment designed based on input from individuals suffering from chronic itch. To this end, participants are instructed to close their eyes while they will continue to listen to the recorded hypnotic script developed based on general hypnotic principles as amongst others described by Yapko (2013). Direct antipruritic suggestions are used such as "your skin will feel so soft, relaxed and cool, it is fully at ease". After these standardized suggestions, the participants will be alerted again. Home exercises (ca 5 min/day) include guided self-hypnosis records with direct antipruritic suggestions comparable to the ones they listen to during the intervention at location.
Treatment groups
Trial outcomes
Primary outcomes
Clinical itch intensity
The primary outcome is short-term (end of treatment) and longer-term (approximately 6 weeks post-treatment) itch reduction (0-10 NRS) \[end of treatment and follow-up compared to baseline; between group\].
Secondary outcomes
Impact of Skin Disease on Daily Life (ISDL) Questionnaire
The impact of the itch on the participants' overall wellbeing is measured by the Impact of Skin Disease on Daily Life (ISDL) Questionnaire \[Evers et al., 2008\]. The following subscales are used: (1) skin status (items 7 t/m 10), (2) physical symptoms (items 11 to 16), (3) scratching (items 17 to 23), (4) impact of disease on daily life (items 24 and 26), (5) psychological functioning (items 27 and 28), and (6) illness cognitions (items 31 and 32).
Hospital Anxiety and Depression Scale (HADS) questionnaire
The validated HADS measuring anxiety and depression.
Medical treatment need
Medical treatment need defined by type of drug/treatment x quantification
itch sensitivity (to the cowhage plant particles).
25 cowhage plant particles are rubbed on the participants' forearm (or at the closest non-lesional site) for 45 seconds and the participants are asked to rate the subsequent itch sensitivity on the 0-10 NRS for itch every half minute for in total up to 4 minutes \[e.g. Blythe et al., 2021; Weng et al., 2022\]. Peak and average itch over the 4 minutes is being calculated.
Other outcomes
Clinical itch intensity
Akin the primary outcome, but now explored over the sessions
VRH and VR-adjusted version of the GAMQ General Attitude towards Medication Questionnaire
The validated GAMQ General Attitude towards Medication Questionnaire, adjusted to the current intervention (elements) will be adminstered at baseline
Hypnotic susceptibility
The validated Stanford Hypnotic Susceptibility Scale C \[e.g. Näring et al., 2001\]) is administered by an experienced hypnotherapist who will bring the participants in hypnosis and give the suggestions according to this scale.
Sponsors and contacts
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Universiteit Leiden
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator