Protocol summary

Summary
The aim of this study is to design and determine the effectiveness of training on the recurrence and severity of nosebleeds in adults with recurrent epistaxis. In this randomized clinical trial, 60 patients with nasal bleeding were referred For treatment to the Matini Hospital of Kashan in the fourth quarter of 1394 Were included. Due to the gradual refer patients to assign participants to treatment groups (n = 30) and control (n = 30) The block method of randomization was used. Demographic and clinical data were recorded.This study was conducted under the supervision of the Ethics Committee of Kashan University of Medical Sciences. Inclusion criteria over 18 years of age, able to read and write, lack of coagulation disorders and Exclusion criteria was unwillingness to cooperate and critically ill patient.Intervention group patients after treatment for 20 minutes were face to face training and was Training package including pamphlets, booklets and CD.The control group was only treated and There was no educational intervention.Recurrent rate and severity of bleeding was assessed in three months after the intervention.Zhang criteria were used to determine the recurrent rate,The lack of blood flow (1), once a month (2), one or more times per week (3) and one or more times per day (4) was considered. And Hugh tools were used to measure the severity of bleeding,The score of less than 1 indicates no bleeding, 1-4 mild bleeding, 4.1 to 7 moderate bleeding and severe bleeding is 7.1 to 1o. Keywords:Recurrent epistaxis, Educational package, recurrent, bleeding severity

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031332242N1
Registration date: 2017-03-13, 1395/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Ensieh Sabbaghi
Name of organization / entity
Kashan University Of Medical Sciences And Health Services Matini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 5534 2020
Email address
sabbaghi-e@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mr. Mohammad Afshar, Nursing PhD,School of Nursing and Midwifery, Kashan University Of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating the effectiveness of the training package on nasal bleeding recurrence rate and intensity in adults with recurrent epistaxis .
Public title
Designing and evaluating the effectiveness of the training package on nasal bleeding recurrence rate and intensity in adults with recurrent epistaxis .
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over18years ؛ Developing the second episode of epistaxis during the past three weeks ؛ Read and write- Lack of coagulation disorders, malignant and anatomic abnormalities؛ No drugs warfarin and heparin Exclusion criteria: Not wanting to continue the study؛ Patients need hospitalization, surgical interventions or blood transfusion
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ghotb ravandi boulevard , Doctor boulevare
City
kashan
Postal code
8715988141
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
( شماره طرح 94157) IR . KAUMS . REC .1394 . 158 با کد

Health conditions studied

1

Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis

Primary outcomes

1

Description
bleeding severity
Timepoint
Monthly for up to three months after intervention
Method of measurement
huag questionnaire

2

Description
The frequency of recurrent bleeding
Timepoint
Monthly for up to three months after intervention
Method of measurement
Zhang rate scale

3

Description
The severity of recurrent bleeding
Timepoint
During the three months after the intervention.
Method of measurement
Zhang rate scale

Secondary outcomes

1

Description
NO
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group patients after treatment for 20 minutes face to face by a trained professional nurses were trained .As well as pamphlets, booklets containing essential content related to the definition, causes, treatment options, early treatment and care needed at home epistaxis home after a design by Ear, nose and throat and nursing professors reviewed and approved the patients were taken.
Category
Prevention

2

Description
The usual treatment for patients in the control group taken by a doctor and nurse. but did not provide them with education and training package they were face to face.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Sabbaghi Ensieh
Street address
Imam hosein squer , Amir kabir street
City
kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Afshar Mohamad
Street address
Ghotb ravandi bouelvared , D octor bouelvared
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Matini Hospital
Full name of responsible person
Sabbaghi Ensieh
Position
Emergency Nurse
Other areas of specialty/work
Street address
Imam hossein squer , Amir kabir street
City
kashan
Postal code
8719674591
Phone
+98 31 5534 2020
Fax
Email
sabbaghi-e@kaums.ac.ir sabaghi.nurse@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Matini Hospital
Full name of responsible person
S abbaghi Ensieh
Position
Master of Nursing
Other areas of specialty/work
Street address
Imam hosein squre , Amir kabir street
City
kashan
Postal code
8719674591
Phone
+98 31 5534 2020
Fax
Email
sabbaghi-e@kaums.ac.ir sabaghi.nurse@ yahoo .com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Matini Hospital
Full name of responsible person
Sabbaghi Ensieh
Position
MS /Emergency nurse
Other areas of specialty/work
Street address
I mam hosein squer, Amir kabir street
City
kashan
Postal code
8719674591
Phone
+98 31 5534 2020
Fax
Email
sabaghi.nurse@yahoo .com sabbaghi-e@ kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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