Clinical trial NCT03906188: Serious Game for Fibromyalgia Patients
Official title: Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: serious game
videogame
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia diagnosed
* Referred pain during the last month

Exclusion Criteria:

-

Primary outcomes:
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Change from Baseline Independence Activities of the daily living up to 3 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from Baseline Independence Activities of the daily living up to 3 weeks
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change from Baseline Independence Activities of the daily living up to 3 weeks
measure: Spanish Pain Questionnaire (SPQ).
timeFrame: Change from Baseline Independence Activities of the daily living up to 3 weeks
Secondary outcomes:
measure: Visual analogic scale (VAS)
timeFrame: Change from Baseline Independence Activities of the daily living up to 3 weeks
measure: The spanish suggestibility inventory
timeFrame: Pre-assessment
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Universidad de Burgos
Study officials:
References:
citation: Carmona, L. G., L.;Ballina, J.; Laffon, A. (2001). Proyecto EPISER 2000: prevalencia de las enfermedades reumáticas en la población española. Metodología, resultados del reclutamiento y características de la población. Revista Española de Reumatología, 28(1), 18-25.
citation: 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.
citation: 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.
citation: 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.
citation: 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.