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

Bender T, Bálint G, Prohászka Z, Géher 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. Review.

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.

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. Review.

Morer C, Roques CF, Françon 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. Review.

Hanzel A, Horvát K, Molics B, Berényi K, Németh B, Szendi K, Varga C. Clinical improvement of patients with osteoarthritis using thermal mineral water at Szigetvár 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.

Hanzel A, Berényi K, Horváth K, Szendi K, Németh B, Varga C. Evidence for the therapeutic effect of the organic content in Szigetvár 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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