ITCHVRITCHNCT06787794
Reducing Itch With Hypnosis and Virtual Reality
A study testing Virtual Reality-assisted hypnosis in people with ITCH and Pruritus, run by Universiteit Leiden at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Virtual Reality-assisted hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- Visual or audiological impairment;
- Pacemaker, defibrillator and/or other electronic (implantable) device of vital importance;
- Pregnancy;
- Lactation;
- Participation in another interventional itch study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jard Mattens, MD, MSc contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University
Leiden, South Holland, 2333 AK
Jard Mattens, MD, MSc, +31637419679, VRH@fsw.leidenuniv.nl
Antoinette I.M. van Laarhoven, PhD, +31 71 527 50 81, VRH@fsw.leidenuniv.nl
About this study
Official title: The Effectiveness of Virtual Reality-assisted Hypnosis in Reducing Itch: a Proof-of-concept Study
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.
Read the detailed description
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.
- Being tested
- Virtual Reality-assisted hypnosis
- Keywords
- Chronic Pruritus, Chronic Itch, Therapy resistant, Virtual Reality (VR), Hypnosis, Relaxation, Distraction
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-assisted hypnosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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
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).
Measured: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Hospital Anxiety and Depression Scale (HADS) questionnaire
The validated HADS measuring anxiety and depression.
Measured: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Medical treatment need
Medical treatment need defined by type of drug/treatment x quantification
Measured: 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).
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.
Measured: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ITCHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Antoinette van Laarhoven, Universiteit Leiden
- Investigators
- Antoinette I.M. van Laarhoven, PhD, Principal investigator, Leiden University, Health Medical and Neuropsychology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787794
- Sponsor's protocol ID
- NL83542.058.23
- Acronym
- VRITCH
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data are available upon reasonable request via an online repository. As online repository, we intend to use DataverseNL, which offers a reliable and secure infrastructure. The Faculty's data stewards are in charge of uploading the publication package to DataverseNL. Files uploaded include the research protocols and outcome data (special care is taken that the information does not allow tracing to the individual patient).
Publications
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.
PubMed 6880820Weng 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.
PubMed 35000228Evers 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.
PubMed 17999699Naring 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.
PubMed 11294117
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality-assisted Hypnosis in Reducing Itch: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06787794
- Acronym / sponsor ID
- VRITCH / NL83542.058.23
- Keywords
- Chronic Pruritus, Chronic Itch, Therapy resistant, Virtual Reality (VR), Hypnosis, Relaxation, Distraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-assisted hypnosis (VRH) | Experimental | Behavioral: Virtual Reality-assisted hypnosisParticipants 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). |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-assisted hypnosisThe 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. | Behavioural | Virtual Reality-assisted hypnosis (VRH) |
Primary outcome
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].
4 secondary outcomes
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)
Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Medical treatment need
Time frame: 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).
Time frame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 6880820Zigmond 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.
- Background: PubMed 35000228Weng 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.
- Background: PubMed 17999699Evers 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.
- Background: PubMed 11294117Naring 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.
- Yapko, M. D. (2013). Essentials of hypnosis. Routledge. (ISBN 9781138814288)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data are available upon reasonable request via an online repository. As online repository, we intend to use DataverseNL, which offers a reliable and secure infrastructure. The Faculty's data stewards are in charge of uploading the publication package to DataverseNL. Files uploaded include the research protocols and outcome data (special care is taken that the information does not allow tracing to the individual patient).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jard Mattens, MD, MSc contact
Antoinette I.M. van Laarhoven, PhD principal investigator
Leiden University, Health Medical and Neuropsychology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-assisted hypnosis in people with ITCH and Pruritus, run by Universiteit Leiden at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoinette I.M. van Laarhoven, PhD (+31 71 527 50 81, a.vanlaarhoven@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical itch intensity (time frame: Baseline, immediately after the intervention, and at follow-up (±6 weeks after end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.