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NCT Number: NCT06787794

Reducing Itch With Hypnosis and Virtual Reality

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.

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Key information

Conditions

Itch Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality-assisted hypnosis

Behavioral

The 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.

Primary outcomes

  1. Clinical itch intensity

    Time frame: 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 outcomes

  1. Impact of Skin Disease on Daily Life (ISDL) Questionnaire

    Time frame: 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).

  2. Hospital Anxiety and Depression Scale (HADS) questionnaire

    Time frame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)

    The validated HADS measuring anxiety and depression.

  3. Medical treatment need

    Time frame: 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

  4. itch sensitivity (to the cowhage plant particles).

    Time frame: 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.

Other outcomes

  1. Clinical itch intensity

    Time frame: Baseline, during the intervention, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)

    Akin the primary outcome, but now explored over the sessions

  2. VRH and VR-adjusted version of the GAMQ General Attitude towards Medication Questionnaire

    Time frame: Baseline (in relation to treatment outcomes)

    The validated GAMQ General Attitude towards Medication Questionnaire, adjusted to the current intervention (elements) will be adminstered at baseline

  3. Hypnotic susceptibility

    Time frame: Baseline (in relation to treatment outcomes)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoinette I.M. van Laarhoven, PhD

CONTACT

[email protected]

+31 71 527 50 81

Jard Mattens, MD, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiteit Leiden

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

The Effectiveness of Virtual Reality-assisted Hypnosis in Reducing Itch: a Proof-of-concept Study

Acronym: VRITCH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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