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Serious Game for Fibromyalgia Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03906188
Enrollment
42
Registered
2019-04-08
Start date
2019-03-30
Completion date
2019-06-15
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

serious game, videogame

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.

Interventions

OTHERLitEmotion

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.

Sponsors

Universidad de Burgos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Fibromyalgia diagnosed * Referred pain during the last month

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Health Assessment Questionnaire (HAQ)Change from Baseline Independence Activities of the daily living up to 3 weeksThe HAQ evaluates the performance in the activities of daily living.
Pittsburgh Sleep Quality Index (PSQI)Change from Baseline Independence Activities of the daily living up to 3 weeksThe 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 weeksThe FIQ evaluates the quality of life in people with fibromyalgia.
Spanish Pain Questionnaire (SPQ).Change from Baseline Independence Activities of the daily living up to 3 weeksThe SPQ evaluates the kind of pain.

Secondary

MeasureTime frameDescription
Visual analogic scale (VAS)Change from Baseline Independence Activities of the daily living up to 3 weeksThe VAS evaluates the level of pain.
The spanish suggestibility inventoryPre-assessmentThis inventory evaluates the level of suggestibility.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026