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

NCT04217941 | Completed

• 1 other identifier: CMH-06-2018
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Keywords

Epistaxis; Randomized control trial; Health education

Outcome Measures

Primary Outcomes (1)

• 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

  0ne month

Study Arms (2)

Health Education with practical demonstration

ACTIVE COMPARATOR

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; Drug: Health Education and practical demonstration of Nasal spray and intranasal ointment

Health education without practical demonstration

PLACEBO COMPARATOR

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

Interventions

Health education with practical demonstration of nasal ointment PROCEDURE

Health education with practical demonstration of medicine was compared to health education without practical demonstration

Also known as: Group A and B

Health Education with practical demonstration; Health education without practical demonstration

Health Education and practical demonstration of Nasal spray and intranasal ointment DRUG

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

Also known as: Health education with practical demonstration group

Health Education with practical demonstration

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The children of age less than 12 years presenting with anterior recurrent epistaxis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead

Study Sites (1)

CMH Mradan

Mardan, KPK, Pakistan

Location

MeSH Terms

Conditions

Epistaxis; Health Education

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ahmed Khan, MBBS, FCPS

  CMH Mardan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ENT consultant

Study Record Dates

• First Submitted: December 29, 2019
• First Posted: January 6, 2020
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)