The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV)
研究概览
简要总结
Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.
详细描述
The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being older than 18 ;
- •have a diagnosis of HIV;
- •present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
- •understand and speak French and;
- •be able to follow the instructions to learn the relaxation technique.
排除标准
- 未提供
研究组 & 干预措施
wait list
usual care for 6 months Autogenic training after 6 months
干预措施: autogenic training (Other)
autogenic training
Autogenic training
干预措施: autogenic training (Other)
结局指标
主要结局
Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV)
时间窗: 3 and 6 months
The PROQOL-HIV questionnaire is composed of 43 Likert-type items (5-point scale ranging from 0=never to 4=always), including 39 items targeting 8 domains of HRQL and general health: physical health and symptoms (9 items), treatment impact (10 items), emotional distress (4 items), health concerns (4 items), body change (4 items), intimate relationships (3 items), social relationships (2 items), and stigma (2 items). Four extra items dealing with religious beliefs, finance, having children, and satisfaction with care are not part of the scoring scheme, but are used to gather additional information from the respondent. Responses to items will be totaled for each dimension and standardized on a scale from 0 to 100 points, in which higher values indicate a better health state.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(3 and 6 months)
- Fatigue Severity Scale (FSS)(3 and 6 months)
- Brief Pain Inventory(3 and 6 months)
- State -Trait Anxiety Inventory (STAI)(3 and 6 months)
- PHQ-9(3 and 6 months)