Patients' Attitudes Towards Open-Label Placebo Implementation Into Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Qualitative data analysis
研究概览
简要总结
The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted.
详细描述
Substantial placebo effects have been known for several decades for a multitude of physical as well as psychological complaints. It is essential to test the acceptability of Open-label placebos (OLPs) of patients and health professionals. The aim of this project is to assess patients' opinions, attitudes, and ideas regarding the administration of OLPs in clinical practice, although they might never have had contact to placebos. A qualitative approach is used and online focus group discussions (FGD) with patients with different clinical conditions, entailing chronic back pain, Parkinson's disease, chronic migraine, chemotherapy induced emesis, and menopausal complaints are conducted. A semi-structured topic guide with open-ended questions will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Signed informed Consent form (see Appendix)
- •Capable of consent (language/cognitive)
- •At least 18 years of age
- •Ability to attend an online conference in regard of physical and psychological condition and technical knowhow and equipment
- •In addition, participants have to be affected by one of the following conditions/disorders:
- •Chronic back pain
- •Chemotherapy-induced emesis (last occurrence at least before 14 days and at maximum before one year)
- •Chronic migraine
- •Parkinson's disease
- •Clinically significant menopausal complaints
排除标准
- •Severe ailment and medication side-effects which would interfere with study participation (e.g., due to concentration impairment)
- •Acute psychological crisis which would affect study participation essentially or suicidality
- •Co-morbidity that overlaps in symptoms with the symptoms necessary for inclusion
- •Essential psychiatric disorders other than moderate depression
结局指标
主要结局
Qualitative data analysis
时间窗: one time assessment at baseline with a duration from max. 60 minutes.
Qualitative data analysis using the approach of "Thematic Analysis". This approach helps to identify, analyze, and interpret patterns of meanings in the form of upcoming "themes" in the qualitative data. Important "themes" deriving from the group discussion between the respective patient groups are explored. . In this manner, important subjective factors of OLP acceptance or non-acceptance can be revealed as well as boundaries of differences within opinions.
次要结局
未报告次要终点