Back to resultsSerious Game for Fibromyalgia Patients
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
LitEmotion
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring serious game, videogame
Eligibility Criteria
Inclusion Criteria:
- Fibromyalgia diagnosed
- Referred pain during the last month
Exclusion Criteria:
-
Sites / Locations
- Universidad de Burgos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LitEmotion group
Control group
Arm Description
This group will play to LitEmotion video game.
This group will no do receive any intervention with the video game
Outcomes
Primary Outcome Measures
Health Assessment Questionnaire (HAQ)
The HAQ evaluates the performance in the activities of daily living.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is an unreported measure which evaluate the quality of sleep.
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ evaluates the quality of life in people with fibromyalgia.
Spanish Pain Questionnaire (SPQ).
The SPQ evaluates the kind of pain.
Secondary Outcome Measures
Visual analogic scale (VAS)
The VAS evaluates the level of pain.
The spanish suggestibility inventory
This inventory evaluates the level of suggestibility.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03906188
Brief Title
Serious Game for Fibromyalgia Patients
Official Title
Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Burgos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
serious game, videogame
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LitEmotion group
Arm Type
Experimental
Arm Description
This group will play to LitEmotion video game.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will no do receive any intervention with the video game
Intervention Type
Other
Intervention Name(s)
LitEmotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Assessment Questionnaire (HAQ)
Description
The HAQ evaluates the performance in the activities of daily living.
Time Frame
Change from Baseline Independence Activities of the daily living up to 3 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is an unreported measure which evaluate the quality of sleep.
Time Frame
Change from Baseline Independence Activities of the daily living up to 3 weeks
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
The FIQ evaluates the quality of life in people with fibromyalgia.
Time Frame
Change from Baseline Independence Activities of the daily living up to 3 weeks
Title
Spanish Pain Questionnaire (SPQ).
Description
The SPQ evaluates the kind of pain.
Time Frame
Change from Baseline Independence Activities of the daily living up to 3 weeks
Secondary Outcome Measure Information:
Title
Visual analogic scale (VAS)
Description
The VAS evaluates the level of pain.
Time Frame
Change from Baseline Independence Activities of the daily living up to 3 weeks
Title
The spanish suggestibility inventory
Description
This inventory evaluates the level of suggestibility.
Time Frame
Pre-assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fibromyalgia diagnosed
Referred pain during the last month
Exclusion Criteria:
-
Facility Information:
Facility Name
Universidad de Burgos
City
Burgos
ZIP/Postal Code
09003
Country
Spain
12. IPD Sharing Statement
Citations:
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.
Results Reference
background
PubMed Identifier
21794700
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.
Results Reference
background
PubMed Identifier
3487324
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.
Results Reference
background
PubMed Identifier
15485007
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.
Results Reference
background
PubMed Identifier
21794365
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.
Results Reference
background
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Serious Game for Fibromyalgia Patients
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