Determining the effect of harmonica playing on pulmonary function in children with cystic fibrosis
Design
A clinical trial with a control group, with factorial groups, randomized, on 70 patients, for randomization of the same balls that are written inside each of the control or intervention groups and chosen by the child.
Settings and conduct
The study will be conducted at thePulmonary Clinic of the Children’s Medical Center .Demographic data and contact information will be collected for follow-up. Spirometry will measure the dependent variable before the intervention. Participants will be randomized using labeled balls ("intervention" or "control").
The intervention group will perform harmonica and breathing exercises (15 minutes, twice daily for 2 months) with routine airway clearance. The control group will only perform routine airway clearance.
After 2 months, follow-up spirometry will be conducted.
Participants/Inclusion and exclusion criteria
The participant with a positive sweat test (chloride value ≥ 60 mmol/L) referred to the lung clinic of the Children's Medical Center Hospital. Children aged 8-18 years. The child should not have experience working with harmonica. Patients who referred for the first time are not included in the study
Intervention groups
In the intervention group, the airway cleaning routine recommended by the doctor along with breathing exercises with the harmonica
In the control group, only the airway cleaning routine
Main outcome variables
Variables: first second forced expiratory volume and forced vital capacity
Determining and comparing forced expiratory volume in the first second and forced vital capacity before and two months after the intervention in each of the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241208063992N1
Registration date:2024-12-23, 1403/10/03
Registration timing:prospective
Last update:2024-12-23, 1403/10/03
Update count:0
Registration date
2024-12-23, 1403/10/03
Registrant information
Name
Hanieh Tavasoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3373 3994
Email address
hanietavasoli2024@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-04, 1403/10/15
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of harmonica playing on pulmonary function in children with Cystic Fibrosis
Public title
Effect of harmonica playing on pulmonary function in children with Cystic Fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The participant must have a positive sweat test (chloride value ≥ 60 mmol/L) (11).
Patients with a positive sweat test should go to the lung clinic of the Children's Medical Center.
Children should be between the ages of 8-18 years.
The child should not have a history of working with an oral instrument.
Patients who have been referred for the first time and have recently been diagnosed with a disease and do not have a history of performing airway cleaning routine, will not be included in the study.
Exclusion criteria:
Patients who have a history of playing wind instruments.
Patients who present for the first time and have a newly diagnosed disease and do not perform routine airway clearance.
Age
From 8 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Two completely similar marbles, one of which is written for the intervention group and the other for the control group, the child chooses one marble. Based on that, it is determined which group it belongs to.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
No. 66, Jangravi St., Khavaran St
City
Tehran
Province
Tehran
Postal code
1771618415
Approval date
2024-12-07, 1403/09/17
Ethics committee reference number
IR.TUMS.FNM.REC.1403.157
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations
Primary outcomes
1
Description
Forced exhalation reserve volume in the first second, scientific definition: the amount of air that is forced out of the lungs with pressure in the first second (27). Practical definition: it is a respiratory parameter that is measured in the spirometry test.
Timepoint
Before the start of the intervention, two months after the start of the intervention
Method of measurement
In this study, respiratory factors are measured with a spirometry device made in Austria, Schiller factory, GANSHORN SpiroScout model and a spirometry filter made by Lemon Medical Company. The device is periodically calibrated according to the protocol of the Children's Medical Center hospital.
Secondary outcomes
1
Description
Forced vital capacity, scientific definition. : The volume of air that comes out of the lungs with maximum power after a deep breath (27). Practical definition: It is a respiratory parameter that is measured in the spirometry test.
Timepoint
Before the start of the intervention, two months after the start of the intervention
Method of measurement
In this study, respiratory factors are measured with a spirometry device made in Austria, Schiller factory, GANSHORN SpiroScout model and a spirometry filter made by Lemon Medical Company. The device is periodically calibrated according to the protocol of the Children's Medical Center hospital.
Intervention groups
1
Description
Intervention group:Before starting the intervention, the dependent variable is based on the routine of the lung clinic before the intervention, in the lung clinic with a model spirometry device.(Schiller, GANSHORN SpiroScout, Austria) will be measured. The spirometry device is periodically calibrated according to the hospital protocol of the Children's Medical Center. In this section, demographic information along with contact number will be collected for follow-up. The steps for conducting the exercises will be explained based on the type of group and provided to the participants in the form of a brochure. If the participant is in the intervention group, the simplest breathing exercise using the harmonica will be individually taught to the participant by the researcher, along with gifting a harmonica. Since children may forget the breathing exercises with the harmonica, an educational video on this subject will be prepared by the researcher and, after approval by a music instructor and the supervisor, will be provided to the intervention group.Learning diaphragmatic breathing is the prerequisite for harmonica training. Children will be taught to stand next to a wall or lie on their back, placing one hand on their chest and the other on their abdomen, ensuring that the chest moves minimally while the abdomen moves maximally. They will begin deep breathing slowly through the nose and exhale through the mouth. According to studies, the inhalation and exhalation in diaphragmatic breathing should take a total of approximately 6 seconds. Therefore, the child will be instructed to inhale for three counts and exhale for three counts. Additionally, the use of the harmonica and blowing and suction exercises will be taught to the child. Training will continue until appropriate feedback is achieved.Necessary instructions about the frequency and duration of harmonica exercises will be given to the child and their caregiver during the sampling session. (Breathing exercises and harmonica practice will be done twice a day, each session lasting 15 minutes, for two months). The duration and daily implementation of the intervention were designed based on two previous studies. Participants will be asked to adhere to home exercises by recording their practice on provided sheets. Furthermore, participants will be requested to send a one-minute audio recording of their harmonica practice to the researcher daily using accessible media.We will remind the child and his family that the oral intervention should be performed in addition to the airway cleaning routine prescribed by the doctor (including respiratory physiotherapy, fumigation therapy, breathing exercise (huffing)) and should not replace the airway cleaning routine.During the 2 months that the child performs the intervention, the researcher encourages the samples to perform the intervention by following up and sending a reminder message. Also, by creating a group and sending voice feedback in the group and creating a competitive atmosphere, the researcher will encourage children to do the intervention continuously. After 2 months, the client will be contacted to go to the clinic to get a spirometry test again and the test before and after the intervention will be compared.
Category
Treatment - Devices
2
Description
Control group: group:Before starting the intervention, the dependent variable is based on the routine of the lung clinic before the intervention, in the lung clinic with a model spirometry device.(Schiller, GANSHORN SpiroScout, Austria) will be measured. The spirometry device is periodically calibrated according to the hospital protocol of the Children's Medical Center. In this section, demographic information along with contact number will be collected for follow-up. The steps of doing the exercises are explained according to the type of group and are provided to the samples in the form of brochures. The airway cleaning routine prescribed by the doctor (including respiratory physiotherapy, fumigation therapy, breathing exercise (huffing)) according to the routine The treatment should be done every day. After 2 months, the client will be contacted to go to the clinic to get a spirometry test again.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
Hanieh Tavassoli
Street address
No. 66, Jangravi St., Khavaran St
City
Tehran
Province
Tehran
Postal code
1771618415
Phone
+98 21 6147 2625
Email
hanietavasoli2024@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Razieh Masoomi
Street address
No. 66, Jangravi St,. Khavaran St
City
Tehran
Province
Tehran
Postal code
۱۷۷۱۶۱۸۴۱۵
Phone
+98 21 6105 4116
Email
hanietavasoli2024@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The researcher herself
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Tavassoli
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 66, Jangravi St,. Khavaran St
City
Tehran
Province
Tehran
Postal code
1771618415
Phone
+98 21 3373 3994
Email
hanietavasoli2024@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Tavassoli
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 66, Jangravi St,. Khavaran St
City
Tehran
Province
Tehran
Postal code
1771618415
Phone
+98 21 3373 3994
Email
hanietavasoli2024@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hanieh Tavassoli
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 66, Jangravi St,. Khavaran St
City
Tehran
Province
Tehran
Postal code
1771618415
Phone
+98 21 3373 3994
Email
hanietavasoli2024@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A piece of data such as information about the main outcome
When the data will become available and for how long
The access period starts 6 months after the publication of the results
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Designing respiratory rehabilitation programs for children with cystic fibrosis.
Educating and encouraging parents and nurses to use non-invasive techniques such as music therapy to improve lung function.
Conducting further studies and developing similar interventions for other age groups or respiratory diseases.
From where data/document is obtainable
Please Email me :hanietavasoli2024@gmail.com
What processes are involved for a request to access data/document
After viewing and reviewing the request as soon as possible