Randomized Clinical Trial: Efficacy of Recreational-therapeutic Use of Video Games on the Emotional State of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Hamilton Rating for Depression
研究概览
简要总结
According to the latest published literature reviews, stroke patients have a prevalence of 19.5% of minor depression and 21.7% of major depression. Furthermore, the loss of autonomy is the most strongly correlated variable in these emotional disorders. In addition, emotional disturbances - in particular anxiety, sadness, crying, and anhedonia - are interpreted as natural reactions to the loss of physical capacity. Along these lines, it has been shown that the use of Virtual Reality (VR) as a co-adjuvant therapy of neuro-rehabilitation in stroke patients with emotional disorders decreases the incidence of these disorders.
详细描述
. Primary objective
- To evaluate the impact on mood, anxiety and depression in patients admitted to neurorehabilitation units after the use of non-immersive virtual reality with the Nintento Switch device in their rehabilitation treatment.
Secondary objectives
- To describe the emotional state of patients before the use of non-immersive virtual therapy in their rehabilitation.
- To describe the emotional state of patients after the use of virtual reality in their rehabilitation.
- To compare the emotional state of patients before and after the implementation of virtual therapy in their rehabilitation.
- To describe the emotional state of patients who have not used non-immersive virtual reality in their rehabilitation by choice.
- To evaluate the efficacy of the involvement of the use of virtual reality therapy in patients with altered emotional state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
- As an open-label clinical trial, the allocation to each group is known. The possibility of blinding is not contemplated. Blinded third-party assessment will be carried out, as a third party will be used who will not know which treatment each patient is receiving.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be of legal age
- •Fluent in oral and written Spanish.
- •Patients with cognitive functions of expression and comprehension.
排除标准
- •Patients who are not undergoing neurorehabilitation treatment.
- •Patients who have not yet started rehabilitation treatment.
结局指标
主要结局
Hamilton Rating for Depression
时间窗: 10 minutes
to assess the intensity or severity of depression in patients already diagnosed in an estimated time of 10 minutes. Quantitatively assess the severity of symptoms and possible changes. Its original version consists of 21 items and its reduced version 17 items.This scale consists of different questions with 3 and 5 possible answers and which are scored with 0-2 or 0-4, their maximum score is 0-52. Possible outcomes are: not depressed (0-7 points), mild / minor depression (8-13 points), moderate depression (14-18 points), severe depression (19-22 points) and very severe depression (\> 23 points (66.67).
Hospital Anxiety and Depression Scale
时间窗: 10 minutes
Each has between three and five possible answers, with a score of 0-2 or 0-4 respectively. The total score ranges from 0 to 52. They can use different cut-off points when classifying the depressive picture. The Clinical Practice Guide prepared by NICE \[6\], a guide with a high overall quality in its preparation and a score of "highly recommended" according to the AGREE instrument, use the following cut-off points: Not depressed: 0-7 Mild / minor depression: 8-13 Moderate depression: 14-18 Severe depression: 19-22 Very severe depression:\> 23
Mood Assessment Scale
时间窗: 2 minutes
Each item is valued from 0 to 10 points depending on the value chosen by the person, after directly adding the score of the four adjectives corresponding to each subscale and dividing the sum by 4, four scores between 0 and 10 are obtained that quantify the states sad-depressive, anxious, happy and angry-hostile mood of the person checked at the time the scale was performed.
次要结局
- Barthel Scale(2 minutes)
- Canadian neurological scale(10 minutes)
- Mississippi Aphasia Screening Test(5-10 minutes)
- Subjective social support scale (Duke-UNK-11)(8 minutes)
- Pfeiffer scale(10minutes)
- UCLA loneliness scale(10 minutes)
研究者
Patricia Blázquez González
professor
Hospital San Carlos, Madrid