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Completed

NCT Number: NCT04290143

Placebo Development and Validation for Healing Water

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

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Key information

Conditions

Balneology

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harkány Thermal Rehabilitation Centre, Harkány, Baranya, Hungary

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Colored healing water

Other

Patients will be treated with colored healing water for 20 minutes.

Placebo treatment (colored tap water)

Other

Patients will be treated with colored tap water for 20 minutes.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2020
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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