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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05855512
Other study ID # 12/2017/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 27, 2020
Est. completion date December 12, 2020

Study information

Verified date August 2020
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized control trial design (RCT) study was conducted on children aged 6 -11 years


Description:

This randomized control trial design study was conducted on children aged 6 -11 years, visiting the pediatric outpatient department and emergency at Dr. Ruth Pfau Civil Hospital Karachi. For the experimental group, a nursing educational intervention session was conducted with the patient and family/caregiver by the principal investigator, and a doctor provided the usual care/treatment. In contrast, the control group received only the usual care/treatment provided by the doctor. For the control group, educational material on asthma was provided in a booklet according to Global Initiative of Asthma (GINA) guidelines. Pre Childhood-Asthma Control Test (C-ACT) score of participants was measured before the intervention, and post-C-ACT score measurement was made after one month using the same questionnaires and C-ACT tool.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 12, 2020
Est. primary completion date November 10, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria: - Children between the aged 6 to 11 years - Have asthma diagnosed by a physician at least 6-month back - Uncontrolled asthma based on C-ACT score 19 or less 19. Exclusion Criteria: - Chronic respiratory illnesses like T.B. cystitis and fibrosis. - Sinusitis, - Gastrointestinal reflux disease, - Rhinitis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nursing Educational Intervention
Nursing Educational Intervention

Locations

Country Name City State
Pakistan Civil Hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Childhood asthma control test (C-ACT) Score C-ACT Score was measured in both controlled and intervention groups and compared the difference between pre-intervention and post-intervention 4 weeks
Primary Number of times got Admissions due to asthma in the last 4 weeks Using the same questionnaire number of admissions was compared to the difference between pre-intervention and post-intervention by the mean and standard deviation 4 weeks
Secondary Number of times visited emergency due to asthma in last 4 weeks Using the same questionnaire number of admissions was compared to the difference between pre-intervention and post-intervention by the mean and standard deviation 4 weeks
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