Placebo Development and Validation for Healing Water
- Conditions
- Balneology
- Registration Number
- NCT04290143
- Lead Sponsor
- University of Pecs
- Brief Summary
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- willingness to participate in the study
- age between 18-80 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants who responded 'placebo,' to question 1 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 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 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 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 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 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 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Harkány Thermal Rehabilitation Centre
🇭🇺Harkány, Baranya, Hungary
Katalin Dr Szendi
🇭🇺Pécs, Baranya, Hungary
Harkány Thermal Rehabilitation Centre🇭🇺Harkány, Baranya, Hungary