Back to resultsEffect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
Primary Purpose
Epistaxis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Health education with practical demonstration of nasal ointment
Health Education and practical demonstration of Nasal spray and intranasal ointment
Sponsored by
About this trial
This is an interventional treatment trial for Epistaxis focused on measuring Epistaxis, Randomized control trial, Health education
Eligibility Criteria
Inclusion Criteria:
- The children of age less than 12 years presenting with anterior recurrent epistaxis
Exclusion Criteria:
o Children with bleeding disorders.
- Children with liver and renal failure/dysfunction.
- Children using anti-coagulants.
- Those children who have gross deviated nasal septum or nasal polys etc.
- Cases who had history of nasal injuries secondary to trauma.
Sites / Locations
- CMH Mradan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Health Education with practical demonstration
Health education without practical demonstration
Arm Description
Participants assigned to the intervention arm received health education with practical demonstration of nasal spray and intranasal ointment .
Participants assigned to the control arm received only health education regarding nasal spray and intranasal ointment .
Outcomes
Primary Outcome Measures
number of epistaxis episodes
Success rate was measured on number of epistaxis episodes after treatment. The primary outcome variables was control of epistaxis through history and clinical examination on follow up visit
Secondary Outcome Measures
Full Information
NCT ID
NCT04217941
First Posted
December 29, 2019
Last Updated
January 3, 2020
Sponsor
Combined Military Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT04217941
Brief Title
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
Official Title
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital, Pakistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the result of verbally educating the parents about method of intranasal antiseptic cream application versus practically educating and demonstrating how to apply cream intra nasally.
Detailed Description
The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Epistaxis, Randomized control trial, Health education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Education with practical demonstration
Arm Type
Active Comparator
Arm Description
Participants assigned to the intervention arm received health education with practical demonstration of nasal spray and intranasal ointment .
Arm Title
Health education without practical demonstration
Arm Type
Placebo Comparator
Arm Description
Participants assigned to the control arm received only health education regarding nasal spray and intranasal ointment .
Intervention Type
Procedure
Intervention Name(s)
Health education with practical demonstration of nasal ointment
Other Intervention Name(s)
Group A and B
Intervention Description
Health education with practical demonstration of medicine was compared to health education without practical demonstration
Intervention Type
Drug
Intervention Name(s)
Health Education and practical demonstration of Nasal spray and intranasal ointment
Other Intervention Name(s)
Health education with practical demonstration group
Intervention Description
We compared the effect of Health education and practical demonstration for using nasal spray and apply intranasal ointment compared to health education without practical demonstration
Primary Outcome Measure Information:
Title
number of epistaxis episodes
Description
Success rate was measured on number of epistaxis episodes after treatment. The primary outcome variables was control of epistaxis through history and clinical examination on follow up visit
Time Frame
0ne month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The children of age less than 12 years presenting with anterior recurrent epistaxis
Exclusion Criteria:
o Children with bleeding disorders.
Children with liver and renal failure/dysfunction.
Children using anti-coagulants.
Those children who have gross deviated nasal septum or nasal polys etc.
Cases who had history of nasal injuries secondary to trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Khan, MBBS, FCPS
Organizational Affiliation
CMH Mardan
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMH Mradan
City
Mardan
State/Province
KPK
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
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