Serious Game for Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906188
• Other study ID #: IR 3/2018
• Status: Completed
• Phase: N/A
• Start date: March 30, 2019
• Est. completion date: June 15, 2019

Study information

• Verified date: June 2019
• Source: Universidad de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 15, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fibromyalgia diagnosed

• Referred pain during the last month

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Burgos	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Burgos

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Visual analogic scale (VAS)	The VAS evaluates the level of pain.	Change from Baseline Independence Activities of the daily living up to 3 weeks
Secondary	The spanish suggestibility inventory	This inventory evaluates the level of suggestibility.	Pre-assessment