Clinical trial NCT04290143: Placebo Development and Validation for Healing Water
Official title: Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balneology
Keywords: medical water
healing water
placebo
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Harkány Spa Hospital, Harkány, Hungary
name: National Research, Development and Innovation Office, Budapest, Hungary
First posted: 2020-02-28
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind study for testing a placebo development method
Primary purpose: OTHER

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

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants who responded 'placebo,' to question 1
timeFrame: prior to treatment
measure: Number of participants who responded 'colored healing water' to question 1
timeFrame: prior to treatment
measure: Number of participants who responded ' could not tell' to question 1
timeFrame: prior to treatment
measure: Number of participants who responded 'placebo,' to question 2
timeFrame: 10 minutes after the beginning of treatment
measure: Number of participants who responded 'colored healing water' to question 2
timeFrame: 10 minutes after the beginning of treatment
measure: Number of participants who responded ' could not tell' to question 2
timeFrame: 10 minutes after the beginning of treatment
measure: Number of participants who responded 'placebo,' to question 3
timeFrame: Immediately after the end of the treatment
measure: Number of participants who responded 'colored healing water' to question 3
timeFrame: Immediately after the end of the treatment
measure: Number of participants who responded ' could not tell' to question 3
timeFrame: Immediately after the end of the treatment
measure: Number of participants who responded 'placebo,' to question 4
timeFrame: After taking a sower (within 15 minutes after the end of the treatment)
measure: Number of participants who responded 'colored healing water' to question 4
timeFrame: After taking a sower (within 15 minutes after the end of the treatment)
measure: Number of participants who responded ' could not tell' to question 4
timeFrame: After taking a sower (within 15 minutes after the end of the treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Harkány
country: Hungary
facility: Harkány Thermal Rehabilitation Centre
state: Baranya
city: Pécs
country: Hungary
facility: Katalin Dr Szendi
state: Baranya
Study officials:
affiliation: University of Pecs
name: Katalin Dr Szendi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.