Effect of Halotherapy in Children With Asthma

August 1, 2024 updated by: Eda Gulbetekin, Igdir University

Effect of Halotherapy (Salt Therapy) on Oxygen Saturation (SPO2), Asthma Symptoms and Treatment Need in Children With Asthma

Introduction: Asthma is a chronic respiratory disease that can affect all age groups and is characterized by episodic and reversible wheezing, shortness of breath, chest tightness and cough attacks. According to a 2016 report by the United States Department of Disease Control and Prevention (CDC), the prevalence of asthma was 9.6% in children aged 5-11 and 10.5% in children aged 12-17. It has been shown that the prevalence of asthma under the age of 18, which concerns all childhoods, is 8.3%.

Purpose: The aim of the study is to determine the effect of salt therapy rooms on the oxygen saturation, asthma symptoms and treatment needs of children with asthma.

Material Method: The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

"Salt therapy," known as halotherapy, is a treatment method performed in salt chambers lined with salt crystals that are pumped with salt-laden air and is used to combat respiratory diseases, skin conditions, mental fatigue and stress. The word Halos means salt in Greek. This practice is also performed in naturally occurring salt mines or caves in Eastern European countries, which is called "speleotherapy" or "cave salt therapy".

Salt has been used for thousands of years in different parts of the world due to its therapeutic effect, and was first applied for therapeutic purposes by Polish Feliks Bockowski. Although salt mine workers in Poland lack basic needs such as nutrition and have difficult working conditions, their general health has led researchers to study and observe in the salt field. In this observation, it was determined that mine workers were less likely to catch colds or any respiratory system diseases. Salt mines were thought to have health benefits, and salt caves in Eastern Europe and Poland became popular.

The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

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

  • Turkey
      • Iğdır, Turkey, 76000
        • Eda Gülbetekin
    • Iğdır
      • Igdir, Iğdır, Turkey, 76000
        • Eda Gülbetekin

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Asthma diagnosis
  • Being a child between the ages of 4-10
  • Volunteering to participate in research

Exclusion Criteria:

  • Under 4 years of age and over 10 years of age
  • Any other chronic disease
  • not agree to participate in the research

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room.
Combination product: Halotherapy (Salt Therapy)
"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. Scales and SPO2 measurement will be performed before, during and after therapy. The same procedure will be applied to the children in the control group, but no therapy will be applied. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
Experimental: Control Group
The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
Combination product: Halotherapy (Salt Therapy)
"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. Scales and SPO2 measurement will be performed before, during and after therapy. The same procedure will be applied to the children in the control group, but no therapy will be applied. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen Saturation (SPO2)
Time Frame: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
Oxygen saturation is a very important measure of how well the lungs are working.
for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Symptom and Treatment Need Scoring
Time Frame: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
All patients were given a form to record their asthma symptoms at the beginning and end of the study. Daily symptoms (cough, wheezing, shortness of breath) were scored using the scoring system. In this scoring, symptom-free status was scored as 0, mild symptoms as 1, moderate symptoms as 2, and severe symptoms as 3.
for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.

Collaborators and Investigators

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

Sponsor

Igdir University

Investigators

  • Principal Investigator: Eda Gülbetekin, PhD, Igdir University

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)

March 6, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eda1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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