FibromyalgiaNCT03906188
Serious Game for Fibromyalgia Patients
A study testing LitEmotion in people with Fibromyalgia, run by Universidad de Burgos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- LitEmotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2019to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fibromyalgia diagnosed
- Referred pain during the last month
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- LitEmotion
- Keywords
- serious game, videogame
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| LitEmotion group | Experimental | This group will play to LitEmotion video game. Receives: Other: LitEmotion |
| Control group | No intervention | This group will no do receive any intervention with the video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Assessment Questionnaire (HAQ)
The HAQ evaluates the performance in the activities of daily living.
Measured: 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.
Measured: 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.
Measured: Change from Baseline Independence Activities of the daily living up to 3 weeks
Spanish Pain Questionnaire (SPQ).
The SPQ evaluates the kind of pain.
Measured: Change from Baseline Independence Activities of the daily living up to 3 weeks
Secondary outcomes (2)
Visual analogic scale (VAS)
The VAS evaluates the level of pain.
Measured: Change from Baseline Independence Activities of the daily living up to 3 weeks
The spanish suggestibility inventory
This inventory evaluates the level of suggestibility.
Measured: Pre-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start30 Mar 2019
- Primary completion30 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA MARIA LARA PALMA, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906188
- Sponsor's protocol ID
- IR 3/2018
- Status last verified
- Jun 2019
- First submitted
- 3 Apr 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
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.
PubMed 21794700Leavitt 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.
PubMed 3487324Rivera 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.
PubMed 15485007Rivera 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.
PubMed 21794365
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study
- ClinicalTrials.gov ID
- NCT03906188
- Acronym / sponsor ID
- IR 3/2018
- Conditions
- Fibromyalgia
- Keywords
- serious game, videogame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LitEmotion group | Experimental | Other: LitEmotionThis group will play to LitEmotion video game. |
| Control group | No intervention | –This group will no do receive any intervention with the video game |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fibromyalgia diagnosed
- Referred pain during the last month
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LitEmotionLitEmotion 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. | Other | LitEmotion group |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Visual analogic scale (VAS)
Time frame: Change from Baseline Independence Activities of the daily living up to 3 weeks
The spanish suggestibility inventory
Time frame: Pre-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- BackgroundCarmona, 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: PubMed 21794700Esteve-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.
- Background: PubMed 3487324Leavitt 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.
- Background: PubMed 15485007Rivera 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.
- Background: PubMed 21794365Rivera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LitEmotion in people with Fibromyalgia, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Assessment Questionnaire (HAQ) (time frame: Change from Baseline Independence Activities of the daily living up to 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906188, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.