Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 4
- 主要终点
- Number of participants who responded 'placebo,' to question 1
研究概览
简要总结
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
详细描述
Introduction
The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the "medication-like" investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.
Target patient number:174
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to participate in the study
- •age between 18-80 years
排除标准
- •patients physically unable to enter or exit the bath tub
- •autoimmune diseases
- •any kind of malignity
- •acute inflammation
- •infection
- •acute coronary syndrome or recent surgical interventions (6 month before enrollment)
结局指标
主要结局
Number of participants who responded 'placebo,' to question 1
时间窗: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 1
时间窗: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 2
时间窗: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 1
时间窗: prior to treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 2
时间窗: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 2
时间窗: 10 minutes after the beginning of treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 3
时间窗: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 3
时间窗: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 3
时间窗: Immediately after the end of the treatment
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'placebo,' to question 4
时间窗: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded 'colored healing water' to question 4
时间窗: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
Number of participants who responded ' could not tell' to question 4
时间窗: After taking a sower (within 15 minutes after the end of the treatment)
The measurement is performed by a questionnaire filled in accordingly by an investigator
次要结局
未报告次要终点