Serious Game for Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: LitEmotion

• Registration Number: NCT03906188
• Lead Sponsor: Universidad de Burgos

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.

Study Timeline

• Study Start: 2019-03-30
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Primary Completion: 2019-05-30
• Status Verified: 2019-06
• Study Completion: 2019-06-15
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Fibromyalgia diagnosed
• Referred pain during the last month

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LitEmotion group	LitEmotion	This group will play to LitEmotion video game.

Primary Outcome Measures

Name	Time	Method
Spanish Pain Questionnaire (SPQ).	Change from Baseline Independence Activities of the daily living up to 3 weeks	The SPQ evaluates the kind of pain.
Pittsburgh Sleep Quality Index (PSQI)	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.
Fibromyalgia Impact Questionnaire (FIQ)	Change from Baseline Independence Activities of the daily living up to 3 weeks	The FIQ evaluates the quality of life in people with fibromyalgia.
Health Assessment Questionnaire (HAQ)	Change from Baseline Independence Activities of the daily living up to 3 weeks	The HAQ evaluates the performance in the activities of daily living.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Burgos; 🇪🇸 Burgos, Spain