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

Sponsor
Combined Military Hospital, Pakistan (Other)
Overall Status
Completed
CT.gov ID
NCT04217941
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
49.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Health education with practical demonstration of nasal ointment
  • Drug: Health Education and practical demonstration of Nasal spray and intranasal ointment
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single blinded
Primary Purpose:
Treatment
Official Title:
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of epistaxis episodes [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CMH Mradan Mardan KPK Pakistan

    Sponsors and Collaborators

    • Combined Military Hospital, Pakistan

    Investigators

    • Principal Investigator: Ahmed Khan, MBBS, FCPS, CMH Mardan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Khan, ENT consultant, Combined Military Hospital, Pakistan
    ClinicalTrials.gov Identifier:
    NCT04217941
    Other Study ID Numbers:
    • CMH-06-2018
    First Posted:
    Jan 6, 2020
    Last Update Posted:
    Jan 6, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Khan, ENT consultant, Combined Military Hospital, Pakistan
    Epistaxis
    Randomized control trial
    Health education
    Additional relevant MeSH terms:
    Epistaxis

    Study Results

    No Results Posted as of Jan 6, 2020