Investigating the effect of chest physiotherapy on the result of pharyngeal culture in children with cystic fibrosis
Design
Non-randomized, single, unblinded clinical trial
Settings and conduct
The method of data collection is as follows: in the specialized and subspecialized children's hospital of Mashhad, the retropharyngeal sample with a sterile cotton swab will be received as a pre-test sample for patients suspected of lower respiratory tract infection. Then chest physiotherapy will be performed for 20 minutes using the standard physiotherapy method based on cystic fibrosis guidelines. which includes percussion, vibration, and positional drainage for 15 minutes. Then, active breathing cycle technique (ACBT) will be performed for 5 minutes. If the patient has expectoration during physiotherapy, it will be discarded. After the end of the physiotherapy, the retropharyngeal sample will be received again with a sterile cotton swab. The second sample is considered as a post-test sample. Both samples will be cultured in TSB medium for 48 to 72 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria are cystic fibrosis disease, consent to participate in the project, suspicion of lower respiratory infection.
Exclusion criteria are cystic fibrosis patients who do not have pulmonary involvement
Intervention groups
Chest physiotherapy
Main outcome variables
Positive culture results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240622062217N1
Registration date:2024-07-08, 1403/04/18
Registration timing:registered_while_recruiting
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Seyedeh shima Hasnai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 7955
Email address
hasanish4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-29, 1403/04/09
Expected recruitment end date
2024-08-30, 1403/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of chest physiotherapy on the result of retro pharyngeal culture in children with cystic fibrosis
Public title
Investigating the effect of chest physiotherapy in children with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Having cystic fibrosis
Suspected respiratory infection as diagnosed by the attending physician
Having no underlying disease other than cystic fibrosis
Exclusion criteria:
Cystic fibrosis patients who do not have pulmonary involvement
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Positive culture results in two samples before and after chest physiotherapy
Timepoint
Pharynx culture sample before and after chest physiotherapy
Method of measurement
Retropharyngeal sample with sterile cotton swab
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each person in the intervention group is also considered as the control group. The sample before physiotherapy is considered as a control sample and the sample after physiotherapy is considered as an intervention or post-test sample. The first sample will be prepared as a retropharyngeal sample with a sterile cotton swab. This sample is considered as a pre-test sample. Then the patient undergoes chest physiotherapy for 20 minutes. After the end of chest physiotherapy, the second sample will be prepared in the same way as a retropharyngeal sample with a sterile cotton swab. The frequency of positive culture in two samples will be compared
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and sub-specialized children's hospital of Mashhad