Serious Game for Fibromyalgia Patients

• ClinicalTrials.gov Identifier: NCT03906188
• Recruitment Status: Completed
• First Posted: April 8, 2019
• Last Update Posted: June 28, 2019
• Sponsor: Universidad de Burgos
• Information provided by (Responsible Party): ANA MARIA LARA PALMA, Universidad de Burgos

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: LitEmotion	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study
• Actual Study Start Date: March 30, 2019
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: June 15, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: LitEmotion group; This group will play to LitEmotion video game.	Other: LitEmotion; 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.
No Intervention: Control group; This group will no do receive any intervention with the video game

Outcome Measures

Primary Outcome Measures :

1. Health Assessment Questionnaire (HAQ) [ Time Frame: Change from Baseline Independence Activities of the daily living up to 3 weeks ]
   The HAQ evaluates the performance in the activities of daily living.
2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from Baseline Independence Activities of the daily living up to 3 weeks ]
   The PSQI is an unreported measure which evaluate the quality of sleep.
3. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Change from Baseline Independence Activities of the daily living up to 3 weeks ]
   The FIQ evaluates the quality of life in people with fibromyalgia.
4. Spanish Pain Questionnaire (SPQ). [ Time Frame: Change from Baseline Independence Activities of the daily living up to 3 weeks ]
   The SPQ evaluates the kind of pain.

Secondary Outcome Measures :

1. Visual analogic scale (VAS) [ Time Frame: Change from Baseline Independence Activities of the daily living up to 3 weeks ]
   The VAS evaluates the level of pain.
2. The spanish suggestibility inventory [ Time Frame: Pre-assessment ]
   This inventory evaluates the level of suggestibility.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Fibromyalgia diagnosed
• Referred pain during the last month

Exclusion Criteria:

-

Contacts and Locations

Locations

Spain

Universidad de Burgos

Burgos, Spain, 09003

Sponsors and Collaborators

Universidad de Burgos

More Information

Publications:

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.

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.

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.

Rivera J, González 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.

Rivera J, Alegre C, Ballina FJ, Carbonell J, Carmona L, Castel B, Collado A, Esteve JJ, Martínez FG, Tornero J, Vallejo MA, Vidal J. [Not Available]. Reumatol Clin. 2006 Mar;2 Suppl 1:S55-66. doi: 10.1016/S1699-258X(06)73084-4. Epub 2008 Dec 10. Spanish.

• Responsible Party: ANA MARIA LARA PALMA, Principal Investigator, Universidad de Burgos
• ClinicalTrials.gov Identifier: NCT03906188
• Other Study ID Numbers: IR 3/2018
• First Posted: April 8, 2019
• Last Update Posted: June 28, 2019
• Last Verified: June 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ANA MARIA LARA PALMA, Universidad de Burgos:

serious game; videogame

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases