Placebo Development and Validation for Healing Water

Study Overview
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Brief Summary
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The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Detailed Description
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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

Official Title
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Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research

Conditions
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Balneology

Intervention / Treatment
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* Other: Colored healing water
* Other: Placebo treatment (colored tap water)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willingness to participate in the study age between 18-80 years Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind study for testing a placebo development method
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colored healing water<br>Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed. | Other: Colored healing water<br>* Patients will be treated with colored healing water for 20 minutes.<br>Other: Placebo treatment (colored tap water)<br>* Patients will be treated with colored tap water for 20 minutes.<br>|
| Placebo Comparator: Placebo - Colored tap water<br>Colored tap water. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. A single 20 minutes-long treatment will be performed. | Other: Colored healing water<br>* Patients will be treated with colored healing water for 20 minutes.<br>Other: Placebo treatment (colored tap water)<br>* Patients will be treated with colored tap water for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who responded 'placebo,' to question 1 | The measurement is performed by a questionnaire filled in accordingly by an investigator | prior to treatment | 
| Number of participants who responded 'colored healing water' to question 1 | The measurement is performed by a questionnaire filled in accordingly by an investigator | prior to treatment | 
| Number of participants who responded ' could not tell' to question 1 | The measurement is performed by a questionnaire filled in accordingly by an investigator | prior to treatment | 
| Number of participants who responded 'placebo,' to question 2 | The measurement is performed by a questionnaire filled in accordingly by an investigator | 10 minutes after the beginning of treatment | 
| Number of participants who responded 'colored healing water' to question 2 | The measurement is performed by a questionnaire filled in accordingly by an investigator | 10 minutes after the beginning of treatment | 
| Number of participants who responded ' could not tell' to question 2 | The measurement is performed by a questionnaire filled in accordingly by an investigator | 10 minutes after the beginning of treatment | 
| Number of participants who responded 'placebo,' to question 3 | The measurement is performed by a questionnaire filled in accordingly by an investigator | Immediately after the end of the treatment | 
| Number of participants who responded 'colored healing water' to question 3 | The measurement is performed by a questionnaire filled in accordingly by an investigator | Immediately after the end of the treatment | 
| Number of participants who responded ' could not tell' to question 3 | The measurement is performed by a questionnaire filled in accordingly by an investigator | Immediately after the end of the treatment | 
| Number of participants who responded 'placebo,' to question 4 | The measurement is performed by a questionnaire filled in accordingly by an investigator | After taking a sower (within 15 minutes after the end of the treatment) | 
| Number of participants who responded 'colored healing water' to question 4 | The measurement is performed by a questionnaire filled in accordingly by an investigator | After taking a sower (within 15 minutes after the end of the treatment) | 
| Number of participants who responded ' could not tell' to question 4 | The measurement is performed by a questionnaire filled in accordingly by an investigator | After taking a sower (within 15 minutes after the end of the treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical water, healing water, placebo