The effect of interactive multimedia education impact on fatigue in hemodialysis patients referred to Urmia hospitals, 2017
Design
Clinical trial with control group, with parallel groups, without blinding
Settings and conduct
This study will be carried out on hemodialysis patients in diaysis unit of Ayatollah Taleghani hospital of Urmia in 2018 with convenience sampling according to inclusion and exclusion criteria. The participants were divided into two random groups of intervention and the control group consist of 40 subjects for each group and there is no blinding. A interactive multimedia education program this education is provided by the researcher with a tablet and consist of film, audio, video, animation, text summaries and then fatigue severity of them evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of other diseases, at least three sessions of dialysis per week
Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Patients in the intervention group acquainted to interactive multimedia education, individually by a tablet, underwent a 45-minute training session in eight sessions that were in line with their dialysis program.
Control group: just received routine care.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160220026662N4
Registration date:2018-10-03, 1397/07/11
Registration timing:retrospective
Last update:2018-10-03, 1397/07/11
Update count:0
Registration date
2018-10-03, 1397/07/11
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4816
Email address
nader1453@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-02-09, 1396/11/20
Actual recruitment end date
2018-08-18, 1397/05/27
Trial completion date
2018-08-18, 1397/05/27
Scientific title
Study of interactive multimedia education impact on fatigue in hemodialysis patients referred to Urmia hospitals, 2017
Public title
Study of interactive multimedia education impact on fatigue in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of another disease based on documented medical records such as cancer and heart failure
not attending in similar educational or massage courses
Having dialysis sessions at least 3 times a week
Exclusion criteria:
Refusal to participate in the study and dissatisfaction for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, for assigning participants in control or intervention groups, block randomization will be used. Thus, blocks will be created based on personal information and inside of each block will divide two equal parts, half of them will consider as intervention group and another part will be control group.
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
Ethics committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-11-08, 1396/08/17
Ethics committee reference number
Ir.umsu.rec.1396.277
Health conditions studied
1
Description of health condition studied
Patients' fatigue under hemodyalisis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue severity in hemodialysis patients
Timepoint
Before intervention, after intervention and 4 weeks after intervention
Method of measurement
Krupp fatigue severity questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the randomization, the fatigue severity questionnaire was completed by patients before the intervention.The education done by 8 sessions of film, audio, video, animation and brochure in which it is provided by the researcher. After that, the questionnaire was completed again by the patient. Four weeks after educational course, the questionnaire was given to patients and completed again.
Category
Other
2
Description
Control group: No intervention was done in the control group and this group only received routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
AyatollahTaleghani hospital
Full name of responsible person
Sara Fooladi
Street address
َAyatollahTaleghani Hospital- Kashani street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3344 4592
Fax
+98 44 3222 9059
Email
hospital_taleghani@yahoo.com
Web page address
https://taleghani.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sara Fooladi
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
sarafooladi1356@gmail.com
Web page address
http://www.msu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sara Fooladi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Fax
+98 44 3222 9059
Email
sarafooladi1356@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo Street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4816
Fax
+98 44 3275 4916
Email
nader1453@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nazloo st., Urmia medical siences university
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3275 4816
Fax
+98 44 3275 4916
Email
nader1453@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Relied on the principle of secrecy and not misuse of others