Reducing Itch With Hypnosis and Virtual Reality

Not Applicable

Recruiting

• Conditions: ITCH; Pruritus

• Registration Number: NCT06787794
• Lead Sponsor: Universiteit Leiden

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.

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-22
• Study Start: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical itch intensity	Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)	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 Outcome Measures

Name	Time	Method
Impact of Skin Disease on Daily Life (ISDL) Questionnaire	Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)	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).
Medical treatment need	Baseline, during the intervention, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)	Medical treatment need defined by type of drug/treatment x quantification
itch sensitivity (to the cowhage plant particles).	Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)	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.
Hospital Anxiety and Depression Scale (HADS) questionnaire	Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)	The validated HADS measuring anxiety and depression.

Trial Locations

Locations (1)

Leiden University; 🇳🇱 Leiden, Zuid-Holland, Netherlands