NCT06250452CompletedPhase 1
Effect of Halotherapy in Children With Asthma
Effect of Halotherapy (Salt Therapy) on Oxygen Saturation (SPO2), Asthma Symptoms and Treatment Need in Children With Asthma
Source: ClinicalTrials.gov · Last updated 2 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 23 Jan 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 1 May 2024
- Lead sponsor
- Igdir University
- Diseases
- Asthma
- NCT number
- NCT06250452
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 70
- From 6 Mar 2024 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any other chronic disease
Age
- Under 4 years of age and over 10 years of age
Other
- not agree to participate in the research
Who the study is looking for
- Asthma diagnosis
- Being a child between the ages of 4-10
- Volunteering to participate in research
Age in the registry: 4 years to 10 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eda Gülbetekin Coordinator of this site? Confirm its status | Iğdır | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.