NCT03906188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

April 3, 2019

Last Update Submit

June 27, 2019

Conditions

Fibromyalgia

Keywords

serious gamevideogame

Outcome Measures

Primary Outcomes (4)

  • Health Assessment Questionnaire (HAQ)

    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)

    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)

    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).

    The SPQ evaluates the kind of pain.

    Change from Baseline Independence Activities of the daily living up to 3 weeks

Secondary Outcomes (2)

  • Visual analogic scale (VAS)

    Change from Baseline Independence Activities of the daily living up to 3 weeks

  • The spanish suggestibility inventory

    Pre-assessment

Study Arms (2)

LitEmotion group

EXPERIMENTAL

This group will play to LitEmotion video game.

Other: LitEmotion

Control group

NO INTERVENTION

This group will no do receive any intervention with the video game

Interventions

LitEmotionOTHER

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.

LitEmotion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fibromyalgia diagnosed
  • Referred pain during the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Burgos

Burgos, 09003, Spain

Location

Related Publications (5)

  • 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.

    BACKGROUND

  • 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.

    PMID: 21794700BACKGROUND

  • 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.

    PMID: 3487324BACKGROUND

  • 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.

    PMID: 15485007BACKGROUND

  • 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.

    PMID: 21794365BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 8, 2019

Study Start

March 30, 2019

Primary Completion

May 30, 2019

Study Completion

June 15, 2019

Last Updated

June 28, 2019

Record last verified: 2019-06

Locations

ES(1)