Enfacement Illusion and Chronic Migraine Pain

NCT04904458 | Unknown

• 1 other identifier: Enfacement Illusion2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Virtual reality; Chronic migraine; Pain; Enfacement illusion; Non-pharmacological treatments; Emotional regulation

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (7)

• Body Image Questionnaire (BIQ)

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

• Positive and Negative Affect Schedule (PANAS)

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

• Body Satisfaction Scale (BSS)

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

• The Hospital Anxiety and Depression Scale (HADS)

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

• The Emotive Regulation Questionnaire (ERQ)

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

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group receives the Enfacement Illusion toward a happy emotional face through a head mounted display.

Other: Experimental group ("enfacement illusion")

Control Group

SHAM COMPARATOR

The control group receives the exposure to a pleasant virtual environment through a head mounted display

Other: Control Group (Pleasant virtual environment exposure)

Interventions

Experimental group ("enfacement illusion") OTHER

Virtual reality enfacement illusion exposure

Experimental group

Control Group (Pleasant virtual environment exposure) OTHER

Pleasant virtual environment exposure

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: There are studies reporting differences in pain perception between man and women (Wiesenfeld-Hallin, 2005)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science Center

Pavia, 27100, Italy

RECRUITING

Related 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.

  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.

  PMID: 10335929 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.

  PMID: 18262508 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.

  PMID: 18177603 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.

  PMID: 31551731 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.

  PMID: 28132277 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.

  PMID: 29478669 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.

  PMID: 6226917 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.

  PMID: 19813138 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.

  PMID: 20467578 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.

  PMID: 19712710 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.

  PMID: 24315986 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.

  PMID: 24725507 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.

  PMID: 16290886 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Pain; Emotional Regulation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cristina Tassorelli, Prof

  Headache Science Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Bottiroli, PhD

CONTACT

0382 380201; sara.bottiroli@mondino.it

Cinzia Fattore, MD

CONTACT

0382 380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 27, 2021
• Study Start: April 30, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: October 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)