Serious Game for Fibromyalgia Patients

June 27, 2019 updated by: ANA MARIA LARA PALMA, Universidad de Burgos

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Burgos, Spain, 09003
        • Universidad de Burgos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fibromyalgia diagnosed
  • Referred pain during the last month

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Independence Activities of the daily living up to 3 weeks
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.
Change from Baseline Independence Activities of the daily living up to 3 weeks
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.
Change from Baseline Independence Activities of the daily living up to 3 weeks
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.
Change from Baseline Independence Activities of the daily living up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Independence Activities of the daily living up to 3 weeks
The spanish suggestibility inventory
Time Frame: Pre-assessment
This inventory evaluates the level of suggestibility.
Pre-assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Burgos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR 3/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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