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NCT06250452

Effect of Halotherapy in Children With Asthma

Completed Phase 1 Last updated 2 August 2024
What this trial tests

Phase 1 trial testing Halotherapy (Salt Therapy) in Therapy, Oxygen Inhalation in 70 participants. Completed in 1 June 2024.

Timeline
6 March 2024
Primary endpoint
1 May 2024
1 June 2024

Quick facts

Lead sponsorIgdir University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposesupportive care
Enrollment70
Start date6 March 2024
Primary completion1 May 2024
Estimated completion1 June 2024
Sites2 locations across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Igdir University

Who can join

Adults 4 to 10, any sex, with Therapy, Oxygen Inhalation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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