The effect of Mobile phone-based education for improving stress, anxiety, depression and pain of patients with beta thalassemia major
Design
In this study, the patients randomly (toss and coin) assign to one of the control and intervention groups. The number of patients in each group is 24.
Settings and conduct
This study is conducted in the choliz ward in Motahari Hospital of Jahrom. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a mobile; Depending on the blood transfusion twice a month; Having at least reading and writing skills; Ability to use telegram software; Patients with 20-30 years old
Non-inclusion criteria: Disabling disorders unrelated to thalassemia
Intervention groups
In this study, the patients in the case group receive four messages per week through the group has designed in the telegram in relation to their health problems. The control group does not receive intervention
Main outcome variables
stress; anxiety; depression and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180207038655N1
Registration date:2018-05-15, 1397/02/25
Registration timing:registered_while_recruiting
Last update:2018-05-15, 1397/02/25
Update count:0
Registration date
2018-05-15, 1397/02/25
Registrant information
Name
Mahsa Imanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5423 5521
Email address
M.Imanian@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mobile Phone-Based Education for Improving Stress, Anxiety, Depression and Pain of Patients with Beta Thalassemia Major
Public title
The Effect of Mobile Phone-Based Education on Patients with Thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a mobile
Depending on the blood transfusion twice a month
Having at least reading and writing skills
Ability to use telegram software
Patients with 20-30 years old
Exclusion criteria:
Disabling disorders unrelated to thalassemia
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples were selected in simple way . Firstly, based on some common characteristics such as: age and sex; the participents were selected in pair and then were randomly (toss and coin) assigned to the intervention and the control groups.
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 Jahrom University of Medical Sciences
Street address
Motahari
City
Jahrom
Province
Fars
Postal code
7417978647
Approval date
2017-12-20, 1396/09/29
Ethics committee reference number
IR.JUMS.REC.1396.103
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D74.0
ICD-10 code description
Congenital methemoglobinemia
Primary outcomes
1
Description
Pain
Timepoint
Beginning and the end of intervention
Method of measurement
Questionaire
2
Description
Stress
Timepoint
Beginning and the end of intervention
Method of measurement
Questionaire
3
Description
Anxiety
Timepoint
Beginning and the end of intervention
Method of measurement
Questionaire
4
Description
Depression
Timepoint
Beginning and the end of intervention
Method of measurement
Questionaire
Secondary outcomes
1
Description
score of life quality
Timepoint
3 months after study
Method of measurement
questionaire
Intervention groups
1
Description
Intervention group: Every week, 4 messages are received in relation to the improvement of stress, anxiety, depression and pain for 3 months.
Category
Rehabilitation
2
Description
Control group: just receive routin care
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Mahsa Imanian
Street address
Janbazan
City
Jahrom
Province
Fars
Postal code
7417978647
Phone
+98 71 5423 5521
Email
mahsa.imanian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mahsa Imanian
Street address
Janbazan
City
Jahrom
Province
Fars
Postal code
7417978647
Phone
+98 71 5423 5521
Email
M.Imanian@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mahsa Imanian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan
City
Jahrom
Province
Fars
Postal code
7417978647
Phone
+98 71 5423 5521
Email
M.Imanian@jums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mahsa Imanian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan
City
Jahrom
Province
Fars
Postal code
7417978647
Phone
+98 71 5423 5521
Email
M.Imanian@jums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mahsa Imanian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan
City
Jahrom
Province
Fars
Postal code
7417978647
Phone
+98 71 5423 5521
Email
M.Imanian@jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potential data can be shared after unidentifiable people
When the data will become available and for how long
6-months after publishing results
To whom data/document is available
Researchers working in academic and scientific institute
Under which criteria data/document could be used
for college students to use the method of study and the results in the clinic
From where data/document is obtainable
Refer to the corresponding author
What processes are involved for a request to access data/document
The requestor can send a email to corresponding author