Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis

January 3, 2020 updated by: Ahmed Khan, Combined Military Hospital, Pakistan

Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Mardan, KPK, Pakistan
        • CMH Mradan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Education with practical demonstration
Participants assigned to the intervention arm received health education with practical demonstration of nasal spray and intranasal ointment .
Procedure: Health education with practical demonstration of nasal ointment
Health education with practical demonstration of medicine was compared to health education without practical demonstration
Other Names:
  • Group A and B
Drug: Health Education and practical demonstration of Nasal spray and intranasal ointment
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
Other Names:
  • Health education with practical demonstration group
Placebo Comparator: Health education without practical demonstration
Participants assigned to the control arm received only health education regarding nasal spray and intranasal ointment .
Procedure: Health education with practical demonstration of nasal ointment
Health education with practical demonstration of medicine was compared to health education without practical demonstration
Other Names:
  • Group A and B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of epistaxis episodes
Time Frame: 0ne month
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
0ne month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMH-06-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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