Reducing Itch With Hypnosis and Virtual Reality

NCT06787794 | Recruiting DMC

• 1 other identifier: NL83542.058.23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

ITCH; Pruritus

Keywords

Chronic Pruritus; Chronic Itch; Therapy resistant; Virtual Reality (VR); Hypnosis; Relaxation; Distraction

Outcome Measures

Primary Outcomes (1)

• Clinical itch intensity

  The primary outcome is short-term (end of treatment) and longer-term (approximately 6 weeks post-treatment) itch reduction (0-10 NRS) \[end of treatment and follow-up compared to baseline; between group\].

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

Secondary Outcomes (4)

• Impact of Skin Disease on Daily Life (ISDL) Questionnaire

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

• Hospital Anxiety and Depression Scale (HADS) questionnaire

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

• Medical treatment need

  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).

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

Other Outcomes (3)

• Clinical itch intensity

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

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

  Baseline (in relation to treatment outcomes)

• Hypnotic susceptibility

  Baseline (in relation to treatment outcomes)

Study Arms (2)

Virtual Reality-assisted hypnosis (VRH)

EXPERIMENTAL

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).

Behavioral: Virtual Reality-assisted hypnosis

Waiting list control

NO INTERVENTION

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.

Interventions

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.

Virtual Reality-assisted hypnosis (VRH)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be adults (aged 18-80 years)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Leiden: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

Leiden University

Leiden, South Holland, 2333 AK, Netherlands

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Yapko, M. D. (2013). Essentials of hypnosis. Routledge. (ISBN 9781138814288)

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoinette I.M. van Laarhoven, PhD

  Leiden University, Health Medical and Neuropsychology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoinette I.M. van Laarhoven, PhD

CONTACT

+31 71 527 50 81; a.vanlaarhoven@fsw.leidenuniv.nl

Jard Mattens, MD, MSc

CONTACT

J.D.J.Mattens@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding possible in the current design (waiting list control)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 22, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Upon publication of the findings in a scientific journal - no end date
• Access Criteria: Data obtained through this study may be provided to qualified researchers with academic interest in chronic itch, while detailing specific plans in relation to the data. Data shared will be anonymized. Approval of the request and execution of all applicable agreements (i.e. a Data Sharing Agreement, requiring the signature of your university's legal team) are prerequisites to the sharing of data with the requesting party. For more information, please contact datastewards\ psy\ ped@fsw.leidenuniv.nl.

Locations

NL (1)