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OpenTrials
Completed

NCT Number: NCT03906188

Serious Game for Fibromyalgia Patients

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Burgos

Burgos, 09003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fibromyalgia diagnosed
  • Referred pain during the last month

Exclusion criteria

-

Treatment and study plan

LitEmotion

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. The spanish suggestibility inventory

    Time frame: Pre-assessment

    This inventory evaluates the level of suggestibility.

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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