- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04617886
The Effect of Mood Induction in Body Image Through Virtual Reality (EMOTION)
The Effect of Mood Induction Procedure of Sadness (vs. Joy) in Body Image Through Virtual Reality
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Valencia, Spain, 46010
- University of Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for CLINICAL population:
- ED diagnosis: Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified
- BDI-II - depression symptomatology scores <29 (for ethical reasons)
- Age between 13 and 18
Exclusion Criteria for CLINICAL population:
- suicide risk: the decision of the psychiatrist/psychologist
- present any medical illness or physical incapacity that could impede the experiment
- diagnosis of Binge Eating Disorder
- Body Mass Index <14 or > 28
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sadness condition
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Sadness state will be induced with a Virtual Reality program.
Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)).
This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013).
Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
Happiness state will be induced with a Virtual Reality program.
Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)).
This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013).
Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
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Experimental: Happiness condition
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Sadness state will be induced with a Virtual Reality program.
Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)).
This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013).
Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
Happiness state will be induced with a Virtual Reality program.
Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)).
This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013).
Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, "I am not valuable", "I see no future"); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Body image dissatisfaction state
Time Frame: Baseline; inmediately after procedure
|
Body Image States Scale (BISS; Cash, Fleming, Alindogan, Steadman y Whitehead, 2002). This is a 6-item self-report questionnaire that measures the individuals' evaluation and affect about their physical appearance (e.g., body image appraisal and satisfaction, as well as emotional experiences) at a particular moment in time: (1) satisfaction with one's overall physical appearance, (2) satisfaction with one's body size and shape, (3) satisfaction with one's weight; (4) feelings of physical attractiveness; (5) current feelings about one's looks relative to how one usually feels; and (6) evaluation of one's appearance relative to how the average person looks. Items are rated on a 9-point bipolar Likert scale. The measure is the composite mean of the items, and higher scores reflect a more favorable body image satisfaction state. The BISS was acceptably internally consistent in the original validation. A Spanish version was translated by the authors of the study. |
Baseline; inmediately after procedure
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Change in the Body image estimation
Time Frame: Baseline; inmediately after procedure
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Software Cognitive (developed at the lab) measuring real and ideal body size estimation based on Glendhill et al. (2017) and using Virtual Reality. The results will be reflected as Body Mass Index change (estimation of the own body size and the ideal body size in BMI). In the present study, a total of 31 female avatars with different BMI were developed. The VR evaluation program allowed for tasks to be performed to estimate the body size (for one's own body and for the ideal body). The body size estimation tasks consisted of two phases. In the first phase, 8 avatars with a different BMI ranging from 14.5 to 28.5 were presented randomly. Ten repetitions were performed for each avatar. In the second phase, 5 avatars were shown with a BMI greater and less in 2 units to the cut-off point estimated in the first phase of the estimation task. Five repetitions were performed for each avatar. |
Baseline; inmediately after procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the Positive and negative affect
Time Frame: Baseline; inmediately after procedure
|
(PANAS; Watson, Clark, and Tellegen, 1988; Spanish adaptation by López-Gómez, Hervás y Vázquez, 2015).The instrument consists of two scales: positive affection scale (PA) and negative affection scale (NA), each consisting of 10 items.
The items are scored using a five-point Likert scale (1 = not at all or very slightly to 5 = very much) in the specified time period (in this study: "right now").
The total score corresponding to the presence of a specific affection, between 10 and 50, is obtained with the sum of the scores of each of the items on the scale.
In the Spanish adaptation of the instrument, by López-Gómez, Hervás and Vázquez (2015), the Cronbach alpha coefficient was .92 for the PA and .88 for the AN.
While the item-total correlations of the AP factor oscillate between .67 and .74,
while those of the AN factor oscillate between .52 and .69.
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Baseline; inmediately after procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1127840
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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