Designing , implementation and evaluation of educational intervention program using mobile application regarding caring behavior on postoperative in patients undergoing lumbar disc herniation surgery
Determining the effect of educational intervention program via a mobile application on the caring behavior of patients after lumbar disc herniation surgery in Fayyaz Bakhsh Hospital, Tehran
Design
Clinical trial with control group, with parallel groups, randomized, non-blind, continuous disease on 30 patients. Blocking method was used for randomization.
Settings and conduct
After obtaining the code of ethics, the researcher provides the mobile application to the intervention group (patients admitted for lumbar disc herniation surgery in Fayyaz Bakhsh Hospital in Tehran) by continuous randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patients undergoing lumbar disc herniation surgery
2. Having a smartphone and knowing how to use it
3- Non-received training before the intervention
Exclusion Criteria
Death of participated patients
Intervention groups
Intervention group: Patients undergoing lumbar disc herniation receiving postoperative care behaviors training through smart mobile application software
Control group: Patients undergoing lumbar disc herniation surgery without receiving postoperative care behaviors training through smart mobile application software
Main outcome variables
Knowledge about care behaviors after lumbar disc surgery;
Attitudes about caring behaviors after lumbar disc surgery;
Performance on care behaviors after lumbar disc surgery.
General information
Reason for update
Acronym
LDH
IRCT registration information
IRCT registration number:IRCT20210117050059N1
Registration date:2021-03-06, 1399/12/16
Registration timing:prospective
Last update:2021-03-06, 1399/12/16
Update count:0
Registration date
2021-03-06, 1399/12/16
Registrant information
Name
Soheila Sadeghpourezbarami
Name of organization / entity
The University OF Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 2038
Email address
s_sadeghpour@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing , implementation and evaluation of educational intervention program using mobile application regarding caring behavior on postoperative in patients undergoing lumbar disc herniation surgery
Public title
educational intervention program using mobile application regarding caring behavior on postoperative in patients undergoing lumbar disc herniation surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for lumbar disc herniation surgery
Having a smartphone and knowing how to use it
Has not received training before the intervention
literate
Exclusion criteria:
Patients with mental disorders.
Patients with learning disabilities.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used. Thus, the researcher identified the people eligible to participate in the study by visiting the hospital. Then, the identified individuals who volunteered to participate in the study were randomly assigned to the experimental and control groups using a quadratic blocking method. The letter A was considered for the intervention group and the letter B for the control group. Then all the permutation compounds of the letters AA and BB, which are 6 different compounds, were written (AABB for combination 1, ABBA for combination 2, ...) and from combinations 1 to 6, one combination was randomly selected. For example, if combination 1 was selected, it meant that the first and second people were in the experimental group and the next two people were in the control group, and this process continued continuously until the sample size was reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Educational intervention in the field of care behaviors after lumbar disc herniation is provided to patients through smart mobile application software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Trabiat Modares University
Street address
Jalal Al-Ahmad St., Nasr Bridge, Tarbiat Modares University, School of Medicine
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.MODARES.REC.1399.209
Health conditions studied
1
Description of health condition studied
Lumbar Disc Herniation
ICD-10 code
M51.26
ICD-10 code description
Other intervertebral disc displacement, lumbar region
Primary outcomes
1
Description
knowledge about caring behaviors after lumbar disc herniation surgery
Timepoint
Immediately after the educational intervention, one month after the educational intervention
Method of measurement
Through a researcher-made questionnaire of LUmbar CAring Tool (LUCAT)
2
Description
Improving attitudes about caring behaviors after lumbar disc herniation surgery
Timepoint
Immediately after the educational intervention, one month after the educational intervention
Method of measurement
Through a researcher-made questionnaire made by LUCAT
3
Description
performance on care behaviors after lumbar disc herniation surgery
Timepoint
Immediately after the educational intervention, one month after the educational intervention
Method of measurement
Through a researcher-made questionnaire made by LUCAT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes three phases: pre-test, content training, and post-test. Pre-test in both intervention and control groups is sent to their mobile phone as an online questionnaire. The application is designed to be installed on the smartphones of the intervention group, ie patients undergoing disc herniation surgery, and how to use it is explained to people. Educational content about caring behaviors after lumbar disc herniation surgery in the intervention group will be activated immediately after completing the pre-test form. Patients have access to educational content for 4 weeks at any time and place. At the end of 4 weeks, access to the educational content is automatically disabled. And the link to receive the post-test is sent by the researcher immediately, one month later, and three months after the educational intervention to both intervention and control groups. The questions are the same in both the pre-test and post-test stages.
Category
Other
2
Description
Control group: The intervention includes three phases: pre-test, content training and post-test. Pre-tests in both intervention and control groups are sent as an online questionnaire to their mobile phones. This group does not receive any training on caring behavior with the help of smart mobile application software. Post-test questionnaire is sent to the control group mobile phone immediately, one and three months after the educational intervention by the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayyaz Bakhsh Hospital
Full name of responsible person
Soheila Sadeghpourezbarami
Street address
Shahid Fayyaz Bakhsh Hospital, Persian Gulf Blvd, 7 km of Karaj Old Road, Fatah Highway.
City
Tehran
Province
Tehran
Postal code
1379613541
Phone
+98 21 6400 5677
Fax
Email
s_sadeghpour@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Trabiat Modares University
Full name of responsible person
Yaghoub Fatollahi
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
s_sadeghpour@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Trabiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fateme Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data on the main consequences can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Repeated measurement analysis to evaluate the duration of training 6 months after the last intervention
From where data/document is obtainable
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir
What processes are involved for a request to access data/document
One week after sending the email by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered.