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The Impact of Videotape on The Self-efficacy and Quality ofLlife in Tracheostomy Patients

Protocol summary

Summary
The aim of this single blinded study،survey the Iimpact of Videotape on Quality of life and Self efficacy in Tracheostomy Patient which Hospitalized in Amir Alam and Imam Khomeini Institute in Tehran. after obtaining written informed consent to Participate in the study, Participants set into two groups based on random block 5 ,the total number of samples is 80 and considering the loss, 45 People calculate for each group.inclusion criteria include: age above 20 years, Self-care ability, No history of mental problems, Lack of work and education in Health Centers. Exclusion criteria include absence of a willingness to cooperation ,exacerbate the situation and unable to cooperation.two group after received routine education from Medical Staff complete sf-36 and self efficacy Questionnaire. In the Intervention group, in addition to the regular training received from the Medical Staff, one tutorial CD with audio and video features, created by the Researcher, was given to the Patients.The CD content was teaching an introduction to Tracheostomy care, showing the Daily care a Tracheostomy Patients need including bathing, shaving, suction, replacing the bandage around Tracheostomy, cleaning Tracheostomy Tube, the Tracheostomy site infection symptoms, how to communicate with Others and presence in public. The Intervention group could watch the movie with no restrictions in terms of the number of times.2 month lather again two groups complete the Questionnaire and Data compare and analysis.

General information

Acronym
not
IRCT registration information
IRCT registration number: IRCT2015110224434N1
Registration date: 2015-11-22, 1394/09/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-22, 1394/09/01
Registrant information
Name
Salam Vatandost
Name of organization / entity
Kurdistan University of Medical Sciences-faculity of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 912 934 2577
Email address
vatandost1366@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences-Research Deputy of University and Research, Deputy of Nursing and Midwifery Faculty
Expected recruitment start date
2015-10-28, 1394/08/06
Expected recruitment end date
2016-02-27, 1394/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Videotape on The Self-efficacy and Quality ofLlife in Tracheostomy Patients
Public title
The Impact of Videotape on The Self-efficacy and Quality of Llife in Tracheostomy Patients
Purpose
Supportive
Inclusion/Exclusion criteria
(Participants:The Participants were Patients with Tracheostomy in the ENT Ward of Amir Alam Hospital and the Imam Khomeini Institute of Cancer in Tehran) (Inclusion Criteria Included: Patients over 20 years old؛ self-care ability؛ cooperative ability؛ not having a history of mental illness؛ full awareness of the time, place and the Person at the time of training؛ completing the Questionnaires؛ access to facilities for watching training videos, lack of experience or training in Health Centers and the ability to communicate in Persian language). (Exclusion Criteria:unwillingness to continue cooperation for any reason؛ deterioration of the Person’s condition and inability to complete the Questionnaire؛ lack of possibility to coordinate an appointment in order to complete the Questionnaire after the Intervention).
Age
From 20 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan Kniversity of Medical Sciencies
Street address
Pasdaran Street, Kurdistan Kniversity of Medical Sciencies,Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
muk.rec.1394227

Health conditions studied

1

Description of health condition studied
Tracheostomy
ICD-10 code
Z93.0
ICD-10 code description
Tracheostomy status

Primary outcomes

1

Description
self-efficacy
Timepoint
discharge and 2 month lather
Method of measurement
sherer self efficay quistionary

2

Description
quality of life
Timepoint
discharge and 2 month lather
Method of measurement
sf-36 quistionary

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
Control group: routine education from medical staff
Category
Behavior

2

Description
Intervention: routine education from medical staff and Videos teaching how to take care of the tracheostomy for use in home for two months
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Alam Hospital
Full name of responsible person
Salam Vatandost, Masterof Sciences in Critical Care Nursing
Street address
Kurdistan University of Medical Siences, Pasdaran Street, Sanandaj,Kurdistan, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini
Full name of responsible person
Salam Vatandost, Masterof Sciences in Critical Care Nursing
Street address
Kurdistan University of Medical Siences, Pasdaran Street, Sanandaj,Kurdistan, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciencies
Full name of responsible person
Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciencies-Research Center
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciencies
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
Kurdistan University of Medical Sciencies-Faculity of Nursing and Midwifery
Full name of responsible person
Salam Vatandost
Position
instructor-Master of Science in Critical Care Nursing
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciencies-Faculity of Nursing and Midwifery-pasdaran street
City
pasdaran street, faculity of Nursing and Midwifery, Kurdistan University of Medical Sciencies, Kurd
Postal code
Phone
+98 87 3362 7636
Fax
Email
vatandost1366@muk.ac.irvatandost1366@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Salam Vatandost
Position
Instructor, Master of sciences in Critical Care Nursing
Other areas of specialty/work
Street address
Pasdaran Street, Faculitty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Kurdistan, Iran
City
Sanandaj
Postal code
Phone
+98 87 3362 7636
Fax
Email
vatandost1366@muk.ac.irvatandost1366@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciencies
Full name of responsible person
Salam Vatandost
Position
Instructor, Master of Sciencies in Critical Care Nursing
Other areas of specialty/work
Street address
Pasdaran Street, Faculity of Nursing and Midwifery, Kurdistan University of Medical Sciencies, Sanandaj, Kurdistan, Iran
City
Sanandaj
Postal code
Phone
+98 87 3362 7936
Fax
Email
vatandost1366@muk.ac.irvatandost1366@gmail.com
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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