Reducing Itch With Hypnosis and Virtual Reality

NCT ID: NCT06787794

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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ITCH Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

No blinding possible in the current design (waiting list control)

Study Groups

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Virtual Reality-assisted hypnosis (VRH)

Participants on the VRH intervention group will come for a total of 8 sessions, including a baseline session, 6 interventional sessions, and a follow-up session.

During the intervention period, participants are requested to perform guided self hypnosis at home according to audio fragments provided (ca. 5 min/day).

Group Type EXPERIMENTAL

Virtual Reality-assisted hypnosis

Intervention Type 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.

Waiting list control

Participants in the waiting list control will participate in the baseline session, final session, and follow-up session (questionnaires and cowhage application) and answer questionnaires online, weekly between baseline and the final session.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality-assisted hypnosis

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Universiteit Leiden

OTHER

Sponsor Role lead

Responsible Party

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Antoinette van Laarhoven

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoinette I.M. van Laarhoven, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University, Health Medical and Neuropsychology Unit

Locations

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Leiden University

Leiden, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Antoinette I.M. van Laarhoven, PhD

Role: CONTACT

+31 71 527 50 81

Jard Mattens, MD, MSc

Role: CONTACT

Facility Contacts

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Jard Mattens, MD, MSc

Role: primary

+31637419679

Antoinette I.M. van Laarhoven, PhD

Role: backup

+31 71 527 50 81

References

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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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35000228 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17999699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11294117 (View on PubMed)

Related Links

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Other Identifiers

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NL83542.058.23

Identifier Type: -

Identifier Source: org_study_id

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