Development and Validation of a Serious Game for Fibromyalgia Patients: Pre-experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Spanish Pain Questionnaire (SPQ).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fibromyalgia diagnosed
- •Referred pain during the last month
排除标准
- 未提供
研究组 & 干预措施
LitEmotion group
This group will play to LitEmotion video game.
干预措施: LitEmotion (Other)
Control group
This group will no do receive any intervention with the video game
结局指标
主要结局
Spanish Pain Questionnaire (SPQ).
时间窗: Change from Baseline Independence Activities of the daily living up to 3 weeks
The SPQ evaluates the kind of pain.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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)
时间窗: Change from Baseline Independence Activities of the daily living up to 3 weeks
The FIQ evaluates the quality of life in people with fibromyalgia.
Health Assessment Questionnaire (HAQ)
时间窗: Change from Baseline Independence Activities of the daily living up to 3 weeks
The HAQ evaluates the performance in the activities of daily living.
次要结局
- Visual analogic scale (VAS)(Change from Baseline Independence Activities of the daily living up to 3 weeks)
- The spanish suggestibility inventory(Pre-assessment)
研究者
ANA MARIA LARA PALMA
Principal Investigator
Universidad de Burgos