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| Name | Class |
|---|---|
| Harkány Spa Hospital, Harkány, Hungary | UNKNOWN |
| National Research, Development and Innovation Office, Budapest, Hungary | UNKNOWN |
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The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colored healing water | Active Comparator | Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed. |
|
| Placebo - Colored tap water | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colored healing water | Other | Patients will be treated with colored healing water for 20 minutes. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katalin Dr Szendi, MD, PhD | University of Pecs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harkány Thermal Rehabilitation Centre | Harkány | Baranya | 7815 | Hungary | ||
| Katalin Dr Szendi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23677421 | Background | Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16. | |
| 2494341 | Background | Szucs L, Ratko I, Lesko T, Szoor I, Genti G, Balint G. Double-blind trial on the effectiveness of the Puspokladany thermal water on arthrosis of the knee-joints. J R Soc Health. 1989 Feb;109(1):7-9. doi: 10.1177/146642408910900104. No abstract available. |
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Not necessary for the study purpose.
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double blind study for testing a placebo development method
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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.
| Placebo treatment (colored tap water) | Other | Patients will be treated with colored tap water for 20 minutes. |
|
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) |
| Pécs |
| Baranya |
| 7624 |
| Hungary |
| 30259887 | Background | Matsumoto S. Evaluation of the Role of Balneotherapy in Rehabilitation Medicine. J Nippon Med Sch. 2018;85(4):196-203. doi: 10.1272/jnms.JNMS.2018_85-30. |
| 28849535 | Background | Morer C, Roques CF, Francon A, Forestier R, Maraver F. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials. Int J Biometeorol. 2017 Dec;61(12):2159-2173. doi: 10.1007/s00484-017-1421-2. Epub 2017 Aug 28. |
| 28956169 | Background | Hanzel A, Horvat K, Molics B, Berenyi K, Nemeth B, Szendi K, Varga C. Clinical improvement of patients with osteoarthritis using thermal mineral water at Szigetvar Spa-results of a randomised double-blind controlled study. Int J Biometeorol. 2018 Feb;62(2):253-259. doi: 10.1007/s00484-017-1446-6. Epub 2017 Sep 27. |
| 30734126 | Background | Hanzel A, Berenyi K, Horvath K, Szendi K, Nemeth B, Varga C. Evidence for the therapeutic effect of the organic content in Szigetvar thermal water on osteoarthritis: a double-blind, randomized, controlled clinical trial. Int J Biometeorol. 2019 Apr;63(4):449-458. doi: 10.1007/s00484-019-01676-3. Epub 2019 Feb 7. |