Placebo Development and Validation for Healing Water

February 26, 2020 updated by: University of Pecs

Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research

The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Baranya
      • Harkány, Baranya, Hungary, 7815
        • Harkány Thermal Rehabilitation Centre
      • Pécs, Baranya, Hungary, 7624
        • Katalin Dr Szendi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Colored healing water
Colored medical water in a bath tub. A single 20 minutes-long treatment will be performed.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
prior to treatment
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
prior to treatment
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
prior to treatment
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
10 minutes after the beginning of treatment
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
10 minutes after the beginning of treatment
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
10 minutes after the beginning of treatment
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
Immediately after the end of the treatment
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
Immediately after the end of the treatment
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
Immediately after the end of the treatment
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
After taking a sower (within 15 minutes after the end of the treatment)
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
After taking a sower (within 15 minutes after the end of the treatment)
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
After taking a sower (within 15 minutes after the end of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Collaborators

Harkány Spa Hospital, Harkány, Hungary
National Research, Development and Innovation Office, Budapest, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

February 7, 2020

Study Completion (ACTUAL)

February 7, 2020

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OTKA_131531_PLACEBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not necessary for the study purpose.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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