Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250452
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-01-23
Brief Title:
Effect of Halotherapy in Children With Asthma
Sponsor:
Igdir University
Organization:
Igdir University
Study Overview
Official Title:
Effect of Halotherapy Salt Therapy on Oxygen Saturation SPO2 Asthma Symptoms and Treatment Need in Children With Asthma
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 96 in children aged 5-11 and 105 in children aged 12-17 It has been shown that the prevalence of asthma under the age of 18 which concerns all childhoods is 83
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 005 d 08 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
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 005 d 08 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
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 005 d 08 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
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 005 d 08 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None