Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-30
Study Completion Date
2024-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Migraine
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
The experimental group receives the Enfacement Illusion toward a happy emotional face through a head mounted display.
Group Type
EXPERIMENTAL
Experimental group ("enfacement illusion")
Intervention Type
OTHER
Virtual reality enfacement illusion exposure
Control Group
The control group receives the exposure to a pleasant virtual environment through a head mounted display
Group Type
SHAM_COMPARATOR
Control Group (Pleasant virtual environment exposure)
Intervention Type
OTHER
Pleasant virtual environment exposure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Experimental group ("enfacement illusion")
Virtual reality enfacement illusion exposure
Intervention Type
OTHER
Control Group (Pleasant virtual environment exposure)
Pleasant virtual environment exposure
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Accomplish the clinical characteristics included in the ICHD-III version for chronic migraine.
2. Age between \>18 to 65 year old (only women).
3. Previous history of migraine as primary headache.
4. Pain perception between 20 and 80 on a 0-100 VAS.
2. Age between \>18 to 65 year old (only women).
3. Previous history of migraine as primary headache.
4. Pain perception between 20 and 80 on a 0-100 VAS.
Exclusion Criteria
1. Dementia, epilepsy, psychosis, mental retardation, pregnant and breastfeeding women.
2. Visual problems
2. Visual problems
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cristina Tassorelli, Prof
Role: PRINCIPAL_INVESTIGATOR
Headache Science Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Headache Science Center
Pavia, , Italy
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Italy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. doi: 10.1016/s1550-8579(05)80042-7.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Enfacement Illusion2020
Identifier Type: -
Identifier Source: org_study_id