Balneology
Conditions
Keywords
medical water, healing water, placebo
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
Interventions
OTHERColored healing water
Patients will be treated with colored healing water for 20 minutes.
OTHERPlacebo treatment (colored tap water)
Patients will be treated with colored tap water for 20 minutes.
Sponsors
Harkány Spa Hospital, Harkány, Hungary
National Research, Development and Innovation Office, Budapest, Hungary
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
double blind study for testing a placebo development method
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 '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 ' 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 '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 ' 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 '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 |
Countries
Hungary
Outcome results
None listed