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Enfacement Illusion and Chronic Migraine Pain

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Experimental group ("enfacement illusion")
Control Group (Pleasant virtual environment exposure)
Sponsored by
IRCCS National Neurological Institute "C. Mondino" Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Virtual reality, Chronic migraine, Pain, Enfacement illusion, Non-pharmacological treatments, Emotional regulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Headache Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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).
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.
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.
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.
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

Full Information

First Posted
May 5, 2021
Last Updated
October 12, 2021
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04904458
Brief Title
Enfacement Illusion and Chronic Migraine Pain
Official Title
The Effects of the "Enfacement Illusion" on Pain Perception in Patients Suffering From Chronic Migraine.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Virtual reality, Chronic migraine, Pain, Enfacement illusion, Non-pharmacological treatments, Emotional regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group receives the Enfacement Illusion toward a happy emotional face through a head mounted display.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The control group receives the exposure to a pleasant virtual environment through a head mounted display
Intervention Type
Other
Intervention Name(s)
Experimental group ("enfacement illusion")
Intervention Description
Virtual reality enfacement illusion exposure
Intervention Type
Other
Intervention Name(s)
Control Group (Pleasant virtual environment exposure)
Intervention Description
Pleasant virtual environment exposure
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Secondary Outcome Measure Information:
Title
Body Image Questionnaire (BIQ)
Description
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
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
Positive and Negative Affect Schedule (PANAS)
Description
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.
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
Body Satisfaction Scale (BSS)
Description
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).
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
The Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
The Emotive Regulation Questionnaire (ERQ)
Description
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.
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
The Difficulties in Emotion Regulation Scale (DERS)
Description
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.
Time Frame
Change fromT0 (baseline) toT1 (at the end of the intervention, i.e. after one-week)
Title
To assess the virtual reality experience within each treatment condition
Description
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
Time Frame
Up to one-week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
There are studies reporting differences in pain perception between man and women (Wiesenfeld-Hallin, 2005)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Dementia, epilepsy, psychosis, mental retardation, pregnant and breastfeeding women. Visual problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Bottiroli, PhD
Phone
0382 380201
Email
sara.bottiroli@mondino.it
First Name & Middle Initial & Last Name or Official Title & Degree
Cinzia Fattore, MD
Phone
0382 380385
Email
cinzia.fattore@mondino.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Tassorelli, Prof
Organizational Affiliation
Headache Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headache Science Center
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Tassorelli, MD
Phone
0382380390
Email
cristina.tassorelli@mondino.it
First Name & Middle Initial & Last Name & Degree
Cinzia Fattore, MD
Phone
0382 380385
Email
cinzia.fattore@mondino.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
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Enfacement Illusion and Chronic Migraine Pain

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