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IRCT20241208063992N1 IRCT 2024-12-23 Tehran University of Medical Sciences Effect of harmonica playing on pulmonary function in children with Cystic Fibrosis Effect of harmonica playing on pulmonary function in children with Cystic Fibrosis 2025-01-04 anticipated 70 Complete https://irct.ir/trial/80688 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Cystic Fibrosis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: A piece of data such as information about the main outcome When: The access period starts 6 months after the publication of the results To whom: It will be available for researchers working in academic and scientific institutions. Conditions: 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. Where to obtain: Please Email me :hanietavasoli2024@gmail.com How to obtain: After viewing and reviewing the request as soon as possible Comments:
public Hanieh Tavassoli
No. 66, Jangravi St,. Khavaran St
Tehran Iran (Islamic Republic of) 1771618415 +98 21 3373 3994 hanietavasoli2024@gmail.com Tehran University of Medical Sciences scientific Hanieh Tavassoli
No. 66, Jangravi St,. Khavaran St
Tehran Iran (Islamic Republic of) 1771618415 +98 21 3373 3994 hanietavasoli2024@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 8 years 18 years Both 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. E84.0 Cystic fibrosis with pulmonary manifestations Treatment - Devices Treatment - Devices 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. 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. 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. 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. The researcher herself Approved 2024-12-07 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o No. 66, Jangravi St., Khavaran St Tehran Tehran Iran (Islamic Republic of)