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Aim: To check the applicability of LitEmotion© in people with Fibromyalgia.
Design: randomized clinical trial, with pre, post and follow-up evaluation. Researchers and outcome evaluator blinded.
Method: The experimental group will play during three weeks to LitEmotion© videogame. The control group will not play.
The study will be a longitudinal-transversal research work with two groups. Findings will us prove the correlation between a right management of emotions and the perception of pain, daily life activities and quality of sleeping.
Sample will be selected by following strict rules; people with no requirements will be dismissed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LitEmotion group | Experimental | This group will play to LitEmotion video game. |
|
| Control group | No Intervention | This group will no do receive any intervention with the video game |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LitEmotion | Other | LitEmotion is a serious video game programmed for helping managing emotions. The experimental group will play during 3 weeks while the control group will not play. The sample will play during 21 days, one session daily, around 45 minutes. After the 21 sessions the group will stop playing during 3 weeks. Therefore, the scales are done three times. In the very beginning (before playing), 21 days after playing, and, finally, 21 days no playing. |
| Measure | Description | Time Frame |
|---|---|---|
| Health Assessment Questionnaire (HAQ) | The HAQ evaluates the performance in the activities of daily living. | Change from Baseline Independence Activities of the daily living up to 3 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is an unreported measure which evaluate the quality of sleep. | Change from Baseline Independence Activities of the daily living up to 3 weeks |
| Fibromyalgia Impact Questionnaire (FIQ) | The FIQ evaluates the quality of life in people with fibromyalgia. | Change from Baseline Independence Activities of the daily living up to 3 weeks |
| Spanish Pain Questionnaire (SPQ). | The SPQ evaluates the kind of pain. | Change from Baseline Independence Activities of the daily living up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogic scale (VAS) | The VAS evaluates the level of pain. | Change from Baseline Independence Activities of the daily living up to 3 weeks |
| The spanish suggestibility inventory | This inventory evaluates the level of suggestibility. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Burgos | Burgos | 09003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Carmona, L. G., L.;Ballina, J.; Laffon, A. (2001). Proyecto EPISER 2000: prevalencia de las enfermedades reumáticas en la población española. MetodologÃa, resultados del reclutamiento y caracterÃsticas de la población. Revista Española de ReumatologÃa, 28(1), 18-25. | ||
| 21794700 | Background | Esteve-Vives J, Rivera J, A Vallejo M; Grupo ICAF. [Assessment of functional capacity in fibromyalgia. Comparative analysis of construct validity of three functional scales]. Reumatol Clin. 2010 May-Jun;6(3):141-4. doi: 10.1016/j.reuma.2009.10.008. Epub 2010 Jan 27. Spanish. | |
| 3487324 |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Pre-assessment |
| Background |
| Leavitt F, Katz RS, Golden HE, Glickman PB, Layfer LF. Comparison of pain properties in fibromyalgia patients and rheumatoid arthritis patients. Arthritis Rheum. 1986 Jun;29(6):775-81. doi: 10.1002/art.1780290611. |
| 15485007 | Background | Rivera J, Gonzalez T. The Fibromyalgia Impact Questionnaire: a validated Spanish version to assess the health status in women with fibromyalgia. Clin Exp Rheumatol. 2004 Sep-Oct;22(5):554-60. |
| 21794365 | Background | Rivera J, Alegre C, Ballina FJ, Carbonell J, Carmona L, Castel B, Collado A, Esteve JJ, Martinez FG, Tornero J, Vallejo MA, Vidal J. Documento de consenso de la Sociedad Espanola de Reumatologia sobre la fibromialgia. Reumatol Clin. 2006 Mar;2 Suppl 1:S55-66. doi: 10.1016/S1699-258X(06)73084-4. Epub 2008 Dec 10. No abstract available. Spanish. |
| D009422 |
| Nervous System Diseases |