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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04617886
Other study ID # 1127840
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 16, 2020
Est. completion date December 31, 2022

Study information

Verified date November 2022
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of emotional induction of sadness (vs. joy) on the mental representation of the body image through the virtual reality


Description:

The general objective of this study is to analyze the impact of emotional induction (sadness vs. joy) on the two dimensions (perceptive and affective) of body image with the help of virtual reality. Thus, it is hypothesized that a negative emotional induction may partially explain the change in body image measures.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Sadness induction
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 induction
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.

Locations

Country Name City State
Spain University of Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Body image dissatisfaction state 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
Primary Change in the Body image estimation 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
Secondary Change in the Positive and negative affect (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. Baseline; inmediately after procedure
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