Serious Game for Fibromyalgia Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: LitEmotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fibromyalgia diagnosed Referred pain during the last month Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LitEmotion group<br>This group will play to LitEmotion video game. | Other: LitEmotion<br>* 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.<br>|
| No Intervention: Control group<br>This group will no do receive any intervention with the video game | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Pre-assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serious game, videogame