Reducing Itch With Hypnosis and Virtual Reality

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 ant

Первичные конечные точки

• Clinical itch intensity [Срок оценки: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)]

Вторичные конечные точки (4)

• Impact of Skin Disease on Daily Life (ISDL) Questionnaire [Срок оценки: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)]
• Hospital Anxiety and Depression Scale (HADS) questionnaire [Срок оценки: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)]
• Medical treatment need [Срок оценки: Baseline, during the intervention, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)]
• itch sensitivity (to the cowhage plant particles). [Срок оценки: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Leiden University — Leiden

Публикации

• 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. PMID 6880820
• 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. PMID 35000228
• 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. PMID 17999699
• 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. PMID 11294117

Идентификаторы

NCT: NCT06787794 · NL83542.058.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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