Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-01-31
2026-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
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).
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Universiteit Leiden
OTHER
Responsible Party
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Antoinette van Laarhoven
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Related Links
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Yapko, M. D. (2013). Essentials of hypnosis. Routledge. (ISBN 9781138814288)
Other Identifiers
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NL83542.058.23
Identifier Type: -
Identifier Source: org_study_id
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