This study aims to assess the effectiveness of VRH in reducing itch along with its psychological burden in individuals with chronic itch.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study will be conducted to assess whether a VRH intervention is a useful
technique (compared to a waiting list control group) (with clinically relevant
effect) for short-term (during and at end of treatment) and longer-term
(approximately 6 weeks post-treatment) itch reduction in terms of clinical itch
intensity (0-10 NRS) [various time points during and after treatment compared
to baseline].
Secondary outcome
The study will furthermore be conducted to assess whether VRH intervention is a
useful technique (compared to a waiting list control group) (with clinically
relevant effect) in terms of (a) the impact of the itch and overall wellbeing
(Impact of Skin Disease on Daily Life (ISDL) scales for skin status, physical
symptoms, scratching, impact of illness, psychological functioning and illness
cognitions; and the Hospital Anxiety and Depression Scale (HADS)), (b) medical
treatment need (type of drug/treatment x quantification), and (c) itch
sensitivity (upon application of cowhage) [end of treatment and follow-up
compared to baseline].
Finally, the study will be conducted to assess the extent to which treatment
confidence, hypnotic susceptibility, and perceived presence in the VR
environment correlate with the difference in clinical itch intensity at the end
of treatment and at follow-up compared to with baseline.
Background summary
Chronic itch is a disabling condition with currently limited treatment options.
Chronic itch can cause severe sleep disturbances and may even trigger
depression and suicidal ideations. 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.
Study 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
Randomised controlled trial investigating the effects of a VRH treatment from
baseline to 6 sessions and at follow-up (ca. 6 weeks after the end of
treatment) compared to a waiting list control group.
Intervention
The VRH group will receive 6 virtual reality hypnosis therapy sessions over the
course of ca. 7-18 weeks, along with instructions to listen to a guided
self-hypnosis recording daily. During this time, the waiting list control group
will be asked to complete the same questionnaires concerning their itch
intensity and overall wellbeing.
Study burden and risks
Participation in this study requires some time investment (±13h over ca. 7-18
weeks and one follow-up session of ±1h after ca. 6 weeks). Furthermore, VR can
cause motion sickness (hence severe susceptibility to motion sickness serves as
an exclusion criterium), and both VR and hypnosis may evoke fear in a very
small group of people. To this end, at all times someone is present to help,
and potentially end the intervention. Lastly, cowhage is applied to the skin of
the participants, which gives a short-term itch sensation only, and has - since
the 1950s - been frequently administered worldwide - amongst others to people
with chronic itch - to our knowledge without reports on (unexpected) side
effects (see also section E9). Given the minimal risks and the itch-reducing
potential of VRH expected from the literature, this study offers hope for
people with chronic itch who are undertreated with their current therapies.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
Adults (aged 18-80 years) with chronic itch of any origin for at least 1 year
prior to inclusion in this study, who have been seen by a physician for the
itch. Itch symptoms lead to psychological and/or functional impairment despite
standard medical treatment. Patients should speak and understand Dutch and be
able to complete questionnaires.
Exclusion criteria
(history of) 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; high susceptibility to motion sickness; balance problems;
face, head, or neck injury; visual or audiological impairment; pacemaker,
defibrillator or other electronic (implantable) device of vital importance;
pregnancy or when lactating, and participation in another interventional itch
study.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83542.058.23 |