Placebo Development and Validation for Healing Water
Overview
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Full Title of Study: “Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Study Primary Completion Date: February 7, 2020
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
- Other: Colored healing water
- Patients will be treated with colored healing water for 20 minutes.
- Other: Placebo treatment (colored tap water)
- Patients will be treated with colored tap water for 20 minutes.
Arms, Groups and Cohorts
- Active Comparator: Colored healing water
- Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed.
- Placebo Comparator: Placebo – Colored tap water
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Number of participants who responded ‘placebo,’ to question 1
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
- Time Frame: 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
Participating in This Clinical Trial
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)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Pecs
- Collaborator
- Harkány Spa Hospital, Harkány, Hungary
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Katalin Dr Szendi, MD, PhD, Principal Investigator, University of Pecs
References
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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.
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