Enfacement Illusion and Chronic Migraine Pain

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904458
• Other study ID #: Enfacement Illusion2020
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2021
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: Sara Bottiroli, PhD
• Phone: 0382 380201
• Email: sara.bottiroli[@]mondino.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Exclusion Criteria:

1. Dementia, epilepsy, psychosis, mental retardation, pregnant and breastfeeding women.

2. Visual problems

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Experimental group ("enfacement illusion")
Virtual reality enfacement illusion exposure
• Control Group (Pleasant virtual environment exposure)
Pleasant virtual environment exposure

Locations

Country	Name	City	State
Italy	Headache Science Center	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. — View Citation

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. — View Citation

Longo MR, Schüür 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. — View Citation

Lotze M, Moseley GL. Role of distorted body image in pain. Curr Rheumatol Rep. 2007 Dec;9(6):488-96. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Pain. 2014 Aug;155(8):1676. Iannetti, Giandomenico [corrected to Iannetti, Gian Domenico]. — View Citation

Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. Review. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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.	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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).	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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.	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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.	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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.	Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary	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	Up to one-week