Clinical trial NCT06787794: Reducing Itch With Hypnosis and Virtual Reality
Official title: The Effectiveness of Virtual Reality-assisted Hypnosis in Reducing Itch: a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ITCH
Pruritus
Keywords: Chronic Pruritus
Chronic Itch
Therapy resistant
Virtual Reality (VR)
Hypnosis
Relaxation
Distraction
Lead sponsor: Universiteit Leiden
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC - Locatie AMC
First posted: 2025-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are randomised over an interventional condition and a waiting list. In case of proven effectivity, the people on the waiting list will be able to also participate at a later instance in the intervention, which will not be part of the analyses within this study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Rationale: 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.

Objective: This study aims to assess the effectiveness of VRH in reducing itch along with its psychological burden in individuals with chronic itch.

Eligibility criteria: Inclusion Criteria:

* 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.
* Participants must speak and understand Dutch and be able to complete questionnaires.

Exclusion Criteria:

* 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;
* Balance problems;
* Face, head, or neck injury;
* Visual or audiological impairment;
* Pacemaker, defibrillator and/or other electronic (implantable) device of vital importance;
* Pregnancy;
* Lactation;
* Participation in another interventional itch study.

Primary outcomes:
measure: Clinical itch intensity
timeFrame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Secondary outcomes:
measure: Impact of Skin Disease on Daily Life (ISDL) Questionnaire
timeFrame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
measure: Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
measure: Medical treatment need
timeFrame: Baseline, during the intervention, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
measure: itch sensitivity (to the cowhage plant particles).
timeFrame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Other outcomes:
measure: Clinical itch intensity
timeFrame: Baseline, during the intervention, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
measure: VRH and VR-adjusted version of the GAMQ General Attitude towards Medication Questionnaire
timeFrame: Baseline (in relation to treatment outcomes)
measure: Hypnotic susceptibility
timeFrame: Baseline (in relation to treatment outcomes)
Locations:
city: Leiden
country: Netherlands
facility: Leiden University
state: Zuid-Holland
Study officials:
affiliation: Leiden University, Health Medical and Neuropsychology Unit
name: Antoinette I.M. van Laarhoven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Weng L, van Laarhoven AIM, Peerdeman KJ, Evers AWM. Induction and generalization of nocebo effects on itch. Exp Dermatol. 2022 Jun;31(6):878-889. doi: 10.1111/exd.14522. Epub 2022 Feb 6.
citation: Evers AW, Duller P, van de Kerkhof PC, van der Valk PG, de Jong EM, Gerritsen MJ, Otero E, Verhoeven EW, Verhaak CM, Kraaimaat FW. The Impact of Chronic Skin Disease on Daily Life (ISDL): a generic and dermatology-specific health instrument. Br J Dermatol. 2008 Jan;158(1):101-8. doi: 10.1111/j.1365-2133.2007.08296.x. Epub 2007 Nov 10.
citation: Naring GW, Roelofs K, Hoogduin KA. The Stanford Hypnotic Susceptibility Scale, Form C: normative data of a Dutch student sample. Int J Clin Exp Hypn. 2001 Apr;49(2):139-45. doi: 10.1080/00207140108410064.