Effect of Halotherapy in Children With Asthma

NCT06250452 | Completed Phase 1

• 1 other identifier: Eda1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Therapy, Oxygen Inhalation

Keywords

Halotherapy; Oxygen Saturation; Asthma; Children with Asthma

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation (SPO2)

  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 Outcomes (1)

• Asthma Symptom and Treatment Need Scoring

  for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.

Study Arms (2)

experimental group

EXPERIMENTAL

"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)

Control Group

EXPERIMENTAL

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)

Interventions

Halotherapy (Salt Therapy) COMBINATION_PRODUCT

"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.

Control Group; experimental group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Igdir University: lead

Study Sites (2)

Eda Gülbetekin

Iğdır, Iğdır, 76000, Turkey (Türkiye)

Location

Eda Gülbetekin

Iğdır, 76000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eda Gülbetekin, PhD

  Igdir University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 9, 2024
• Study Start: March 6, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)