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AzTrials

MigraineNCT04904458

Enfacement Illusion and Chronic Migraine Pain

A study testing Experimental group ("enfacement illusion") in people with Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The concept of body image can be described as "the intentional content of consciousness comprising perceptions, attitudes and beliefs relating to one's body". Over the years, there has been a growing interest in this topic, highlighting that body image can be distorted in people suffering from pain conditions… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Migraine
What is being tested?
Experimental group ("enfacement illusion")
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteItaly
Study dates
30 Apr 2021to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Accomplish the clinical characteristics included in the ICHD-III version for chronic migraine.
  • Age between >18 to 65 year old (only women).
  • Previous history of migraine as primary headache.
  • Pain perception between 20 and 80 on a 0-100 VAS.

Who cannot join

  • Dementia, epilepsy, psychosis, mental retardation, pregnant and breastfeeding women.
  • Visual problems

Trial locations and contacts

1 site in 1 country.

Sara Bottiroli, PhD contact

0382 380201

sara.bottiroli@mondino.it

Cinzia Fattore, MD contact

0382 380385

cinzia.fattore@mondino.it

Italy1 site, 1 recruiting
  • Headache Science Center

    Pavia, 27100

    Cristina Tassorelli, MD, 0382380390, cristina.tassorelli@mondino.it

    Cinzia Fattore, MD, 0382 380385, cinzia.fattore@mondino.it

    Recruiting

Other trials in Italy

About this study

Official title: The Effects of the "Enfacement Illusion" on Pain Perception in Patients Suffering From Chronic Migraine.

The concept of body image can be described as "the intentional content of consciousness comprising perceptions, attitudes and beliefs relating to one's body". Over the years, there has been a growing interest in this topic, highlighting that body image can be distorted in people suffering from pain conditions, especially in the case of chronic pain. One way of modulating the perception of pain through the perception of body image is through the use of interventions based on visual feedback. In this regard, some studies have highlighted the possibility of reducing the perception of pain in healthy and clinical populations with the use of "illusions" of one's own body created through immersive virtual reality. For example, through the use of synchronous visual-tactile multisensory stimulation on one's own face / body and on that of others (fake body), is possible to induce illusions of self-recognition in other fake bodies. In the case of the face, this type of illusion of belonging of other faces is commonly known as the "enfacement illusion", through which is possible to change or modulate the self-representation, with important implications for all those subjects who have distorted body representations, such as patients suffering from chronic pain. The main goal of the present protocol is to evaluate the effects of an experimental treatment based on enfacement illusion on the perception of pain (VAS scale) with respect to a control condition (pleasant virtual environment exposure). The secondary objective is to study any correlations between pain and body image, personal, clinical and psychological intrapersonal variables. One-hundred patients with chronic headache will be randomly assigned to the two conditions: experimental group (based on the "enfacement illusion") and control group (exposed to a pleasant virtual environment). Both conditions include an immersive virtual reality treatment of 3 sessions of 15 minutes each, during one week.

Read the detailed description

The concept of body image can be described as "the intentional content of consciousness comprising perceptions, attitudes and beliefs relating to one's body". Over the years, there has been a growing interest in this topic, highlighting that body image can be distorted in people with pain, especially in the case of chronic pain. In the context of migraine, some studies have shown that the perception of pain can alter both the facial recognition capacity and the visuospatial perception compared to healthy subjects. Furthermore, other studies have shown that by reducing the altered perception of body image in patients with migraine associated with overuse of drugs, it is possible to induce beneficial effects on their affective state and on the perception of pain. One way to modify the perception of pain through the perception of the body image consists in the use of interventions based on visual feedback. Other studies have also highlighted the possibility of reducing the perception of pain in healthy and clinical populations with the use of "illusions" of one's body created through immersive virtual reality. In a pilot study conducted at IRCCS Mondino, the effect of different visual feedback conditions (facial expressions): positive, neutral, negative and white screen (control condition) on the modulation of pain perception in a sample of 38 patients with chronic migraine, demonstrated that the observation of a positive emotional face stimuli, when compared to other conditions, decreased their pain perception. Further, other studies demonstrated that the use of synchronous visual-tactile multisensory stimulation on one's face / body and on that of others (fake body) is able to induce illusions of self-recognition toward the others body part. This illusion of belonging of other faces thus created is known as "enfacement illusion" and seems to be positively correlated to the empathic traits of the subjects mediated by emotion regulation. Other studies show that the "enfacement illusion" seems to be a good strategy for changing the self-representation, with important implications for all those subjects who have distorted body representations, such as patients suffering from chronic pain. This study aims to evaluate whether through the "enfacement illusion" of representing oneself in a happy face exposed through an immersive virtual reality system (experimental group) it is possible to reduce the perception of pain in patients with chronic migraine. This effect would be mediated by an improved body image and empathy for positive emotions. In order to demonstrate the effects of the "enfacement illusion" on their own body representation and pain perception, a control group will be subjected to a positive exposure (pleasant environment) in an immersive virtual environment, which seems to be able to produce distracting effects on pain perception in patients with chronic migraine. It is hypothesized that patients with chronic migraine exposed to the "enfacement illusion" will experience greater pain relief and improve the perception of their body image compared to the control group. Therefore, the present study aims to show a possible relationship between the distortion of the body image and pain perception and, therefore, to demonstrate the effectiveness of the use of "enfacement illusion" as a cognitive behavioral intervention aimed at alleviating pain in clinical populations. Patients in the experimental group will be exposed to the "enfacement illusion" condition, conducted similarly to other studies. In detail, patients will see, through a virtual reality helmet, a virtual body sitting in front of them with a happy face expression. Each session will consist of three phases: (1) habituation to the virtual environment, (2) observation of the virtual facial expression, (3) multisensory stimulations (visuo-tactile stimulation).

Phase (1) habituation to the virtual environment: For approximately 2 minutes the experimenter will ask patients to describe what they see in the virtual environment, as well as the virtual body positioned in front of them.

Phase (2) observation of facial expression: the experimenter will ask patients to focus attention on the face of the virtual body sitting in front of them for about 1 minute.

Phase (3) multisensory with a brush. The multisensory (visual-tactile) stimulation is necessary to induce the sensation of belonging to the virtual body, and specifically to induce the sense of ownership toward the virtual face. The multisensory stimulation will last for 5 minutes.

The control group of this study, will be exposed to a visual stimulation by observing a pleasant immersive virtual reality environment for the duration of 5 minutes. As in the experimental group, in the first 2 minutes of immersion in the virtual environment, the experimenter will ask the patient to describe the virtual environment. Then, the patients will be immersed in the virtual environment for about 5 minutes.

In this frame, the primary goal of this double-blind randomized controlled trial is to assess whether the "enfacement illusion" of representing oneself (inducing the sense of ownership) in a happy face through an immersive virtual reality may reduce the perception of pain in patients with chronic migraine. A secondary goal is to evaluate the effects on the perception of one's body image and on the affective and emotional state of a treatment based on "enfacement illusion" with respect to a control condition. Both treatment protocols consist of 3 session/week, 15 minutes/day, of the virtual reality enfacement illusion exposure vs pleasant virtual environment exposure. Female patients with chronic migraine accomplishing the clinical characteristics included in the ICHD-III version for chronic migraine, with pain perception between 20 and 80 on a 0-100 visual analogue scale will be recruited from Headache Science center Unit of IRCCS Mondino Foundation.

All patients will undergo the following assessment measures:

Pre / post treatment (T0-T1): all subjects will be assessed as regards their affective and emotional state with: Body Satisfaction Scale (BSS), Hospital Anxiety and Depression Scale (HADS), Emotive Regulation Questionnaire (ERQ) , and the Difficulties in Emotion Regulation Scale (DERS), Pain-Visual Analogue Scale (VAS), Body Image Questionnaire (BIQ), and Positive and Negative Affect Schedule (PANAS).

Pre / post visual exposure session: all subjects will be assessed with the Pain-Visual Analogue Scale (VAS), Body Image Questionnaire (BIQ) and Positive and Negative Affect Schedule (PANAS).

After each visual exposure session: the patients of the experimental group will fill in a questionnaire relating to the level of sense of belonging (embodiment) of the virtual body. The control group will fill out a questionnaire relating to the level of immersion in the virtual environment.

Conditions
Migraine
Being tested
Experimental group ("enfacement illusion"), Control Group (Pleasant virtual environment exposure)
Keywords
Virtual reality, Chronic migraine, Pain, Enfacement illusion, Non-pharmacological treatments, Emotional regulation
Medical subject headings
Migraine Disorders, Pain, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental group ("enfacement illusion")Other

    Virtual reality enfacement illusion exposure

  • Control Group (Pleasant virtual environment exposure)Other

    Pleasant virtual environment exposure

Study groups in NCT04904458
Study groupRoleWhat they receive
Experimental groupExperimentalThe experimental group receives the Enfacement Illusion toward a happy emotional face through a head mounted display.
Receives: Other: Experimental group ("enfacement illusion")
Control GroupSham comparatorThe control group receives the exposure to a pleasant virtual environment through a head mounted display
Receives: Other: Control Group (Pleasant virtual environment exposure)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale (VAS)

    To assess the effects on pain perception measured by a 0-100 Visual Analogue Scale (VAS) of a one-week treatment based on "enfacement illusion" compared to a control condition (pleasant virtual environment exposure) in patients with chronic migraine

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

Secondary outcomes (7)
  1. Body Image Questionnaire (BIQ)

    To assess the effects on the perception of one's own body image and on the affective and emotional state of a one-week treatment based on "enfacement illusion" with respect to a control condition (pleasant virtual environment exposure). Pre / post each session all subjects will be evaluated with Body Image Questionnaire (BIQ). BIQ is a 19 -item questionnaire

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  2. Positive and Negative Affect Schedule (PANAS)

    To assess the effects on the perception of one's own body image and on the affective and emotional state of a treatment based on "enfacement illusion" with respect to a control condition (pleasant virtual environment exposure). Pre / post each session all subjects will be evaluated with Positive and Negative Affect Schedule (PANAS).

    Positive Affect Score: scores can range from 10 - 50, with higher scores representing higher levels of positive affect.

    Negative Affect Score: scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  3. Body Satisfaction Scale (BSS)

    To assess the relationship between the affective and emotional state of patients and the change in the perception of pain and one's body image. Before and after the one-week treatment, all subjects will be assessed for what concerns their affective and emotional state with Body Satisfaction Scale (BSS).

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  4. The Hospital Anxiety and Depression Scale (HADS)

    To assess the relationship between the affective and emotional state of patients and the change in the perception of pain and one's body image. Before and after the one-week treatment, all subjects will be assessed for what concerns their affective and emotional state with the Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  5. The Emotive Regulation Questionnaire (ERQ)

    To assess the relationship between the affective and emotional state of patients and the change in the perception of pain and one's body image. Before and after the one-week treatment, all subjects will be assessed for what concerns their affective and emotional state with the Emotive Regulation Questionnaire (ERQ). The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report scale designed to assess habitual use of two commonly used strategies to alter emotion: cognitive reappraisal and expressive suppression.

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  6. The Difficulties in Emotion Regulation Scale (DERS)

    To assess the relationship between the affective and emotional state of patients and the change in the perception of pain and one's body image. Before and after the one-week treatment, all subjects will be assessed for what concerns their affective and emotional state with the Difficulties in Emotion Regulation Scale (DERS). The DERS is a 36-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.

    Measured: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)

  7. To assess the virtual reality experience within each treatment condition

    After each treatment session, the patients of the experimental group will fill in a questionnaire relating to the level of sense of belonging (embodiment) of the virtual body. The control group will fill out a questionnaire relating to the level of immersion and presence in the virtual environment

    Measured: Up to one-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start30 Apr 2021
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04904458
Sponsor's protocol ID
Enfacement Illusion2020
Status last verified
May 2021
First submitted
5 May 2021
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balzarotti, Stefania, Oliver P. John, and James J. Gross. 2010. "An Italian Adaptation of the Emotion Regulation Questionnaire." European Journal of Psychological Assessment. https://doi.org/10.1027/1015-5759/a000009.

  • Costantini M, Musso M, Viterbori P, Bonci F, Del Mastro L, Garrone O, Venturini M, Morasso G. Detecting psychological distress in cancer patients: validity of the Italian version of the Hospital Anxiety and Depression Scale. Support Care Cancer. 1999 May;7(3):121-7. doi: 10.1007/s005200050241.

    PubMed 10335929
  • Longo MR, Schuur F, Kammers MP, Tsakiris M, Haggard P. What is embodiment? A psychometric approach. Cognition. 2008 Jun;107(3):978-98. doi: 10.1016/j.cognition.2007.12.004. Epub 2008 Feb 11.

    PubMed 18262508
  • Lotze M, Moseley GL. Role of distorted body image in pain. Curr Rheumatol Rep. 2007 Dec;9(6):488-96. doi: 10.1007/s11926-007-0079-x.

    PubMed 18177603
  • Matamala-Gomez M, Donegan T, Bottiroli S, Sandrini G, Sanchez-Vives MV, Tassorelli C. Immersive Virtual Reality and Virtual Embodiment for Pain Relief. Front Hum Neurosci. 2019 Aug 21;13:279. doi: 10.3389/fnhum.2019.00279. eCollection 2019.

    PubMed 31551731
  • Nicolodi M, Sandoval V. P012. Body image role in medication-overuse headache associated with persistent depressive disorder. J Headache Pain. 2015 Dec;16(Suppl 1):A111. doi: 10.1186/1129-2377-16-S1-A111. No abstract available.

    PubMed 28132277
  • Porciello G, Bufalari I, Minio-Paluello I, Di Pace E, Aglioti SM. The 'Enfacement' illusion: A window on the plasticity of the self. Cortex. 2018 Jul;104:261-275. doi: 10.1016/j.cortex.2018.01.007. Epub 2018 Feb 9.

    PubMed 29478669
  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PubMed 6226917
  • Sforza A, Bufalari I, Haggard P, Aglioti SM. My face in yours: Visuo-tactile facial stimulation influences sense of identity. Soc Neurosci. 2010;5(2):148-62. doi: 10.1080/17470910903205503. Epub 2009 Oct 7.

    PubMed 19813138
  • Terracciano A, McCrae RR, Costa PT Jr. Factorial and construct validity of the Italian Positive and Negative Affect Schedule (PANAS). Eur J Psychol Assess. 2003;19(2):131-141. doi: 10.1027//1015-5759.19.2.131.

    PubMed 20467578
  • de Tommaso M, Calabrese R, Vecchio E, De Vito Francesco V, Lancioni G, Livrea P. Effects of affective pictures on pain sensitivity and cortical responses induced by laser stimuli in healthy subjects and migraine patients. Int J Psychophysiol. 2009 Nov;74(2):139-48. doi: 10.1016/j.ijpsycho.2009.08.004. Epub 2009 Aug 25.

    PubMed 19712710
  • Valentini E, Martini M, Lee M, Aglioti SM, Iannetti G. Seeing facial expressions enhances placebo analgesia. Pain. 2014 Apr;155(4):666-673. doi: 10.1016/j.pain.2013.11.021. Epub 2013 Dec 6.

    PubMed 24315986
  • Yetkin-Ozden S, Ekizoglu E, Baykan B. Face recognition in patients with migraine. Pain Pract. 2015 Apr;15(4):319-22. doi: 10.1111/papr.12191. Epub 2014 Apr 12.

    PubMed 24725507
  • Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. doi: 10.1016/s1550-8579(05)80042-7.

    PubMed 16290886

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group ("enfacement illusion") in people with Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 Italy. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Bottiroli, PhD (0382 380201, sara.bottiroli@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)). 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 NCT04904458, which also lists 14 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 13 Oct 2021.

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