EpistaxisNCT04217941
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis
A study testing Health education with practical demonstration of nasal ointment and Health Education and practical demonstration of Nasal spray and intranasal ointment in people with Epistaxis, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Epistaxis
- What is being tested?
- Health education with practical demonstration of nasal ointment and Health Education and practical demonstration of Nasal spray and intranasal ointment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children of age less than 12 years presenting with anterior recurrent epistaxis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits
- Conditions
- Epistaxis
- Being tested
- Health education with practical demonstration of nasal ointment, Health Education and practical demonstration of Nasal spray and intranasal ointment
- Keywords
- Epistaxis, Randomized control trial, Health education
- Medical subject headings
- Epistaxis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education with practical demonstration of nasal ointmentProcedure or surgery
Also called Group A and B
Health education with practical demonstration of medicine was compared to health education without practical demonstration
Health Education and practical demonstration of Nasal spray and intranasal ointmentDrug
Also called Health education with practical demonstration group
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
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Procedure: Health education with practical demonstration of nasal ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0ne month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Jun 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khan, Combined Military Hospital, Pakistan
- Investigators
- Ahmed Khan, MBBS, FCPS, Principal investigator, CMH Mardan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217941
- Sponsor's protocol ID
- CMH-06-2018
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Outcome, in Cases of Recurrent Pediatric Epistaxis
- ClinicalTrials.gov ID
- NCT04217941
- Acronym / sponsor ID
- CMH-06-2018
- Conditions
- Epistaxis
- Keywords
- Epistaxis, Randomized control trial, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education with practical demonstration | Active comparator | Procedure: Health education with practical demonstration of nasal ointment, Drug: Health Education and practical demonstration of Nasal spray and intranasal ointmentParticipants assigned to the intervention arm received health education with practical demonstration of nasal spray and intranasal ointment . |
| Health education without practical demonstration | Placebo comparator | Procedure: Health education with practical demonstration of nasal ointmentParticipants assigned to the control arm received only health education regarding nasal spray and intranasal ointment . |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The children of age less than 12 years presenting with anterior recurrent epistaxis
Key exclusion criteria (5 listed)
- o Children with bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education with practical demonstration of nasal ointmentAlso: Group A and BHealth education with practical demonstration of medicine was compared to health education without practical demonstration | Procedure or surgery | Health Education with practical demonstration, Health education without practical demonstration |
| Health Education and practical demonstration of Nasal spray and intranasal ointmentAlso: Health education with practical demonstration groupWe compared the effect of Health education and practical demonstration for using nasal spray and apply intranasal ointment compared to health education without practical demonstration | Drug | Health Education with practical demonstration |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Epistaxis
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Khan, MBBS, FCPS principal investigator
CMH Mardan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education with practical demonstration of nasal ointment and Health Education and practical demonstration of Nasal spray and intranasal ointment in people with Epistaxis, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of epistaxis episodes (time frame: 0ne month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.