The effect of multimedia training on pain management on the severity of pain, depression and catastrophic in patients with non-specific chronic low back pain.
The Effect of Multimedia Training on Pain Intensity, Depression and Catastrophizing in Patients with Chronic Low Back Pain
Design
Clinical trials with two intervention and blind group, double-blind, control group with parallel, randomized, community-based, and pragmatic groups
Settings and conduct
The researcher will complete the questionnaire by referring to clinics in Fasa. Patients will be randomly assigned into two intervention and control groups. In the multimedia tutorial group, seven cd films will be provided to patients over seven weeks, but face-to-face tutorials will be delivered through lectures, question and answer, and slides. At the end of 7 sessions and one month after the intervention, the questionnaires will be completed again by the patients. No training is given in the control group. This is a double-blind clinical trial.
Participants/Inclusion and exclusion criteria
Including criteria: Age more than 18 years, Chronic lower back pain with expert diagnosis, Depression score higher than 14
Exclusion criteria: Unwillingness to participate in the study, Other chronic underlying diseases
Intervention groups
Multimedia education group and face to face training group
Main outcome variables
Pain intensity; Depression; Catastrophic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039074N1
Registration date:2018-03-21, 1397/01/01
Registration timing:prospective
Last update:2018-03-21, 1397/01/01
Update count:1
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Roghiyeh Firoozian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 8075
Email address
r.firooziyan@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimedia training on pain management on the severity of pain, depression and catastrophic in patients with non-specific chronic low back pain.
Public title
A survey of multimedia education on severity of pain, depression and catastrophizing in patients with chronic low back pain.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years
Possibility to attend face to face face-to-face faculty members
Involvement in research on chronic low back pain based on expert diagnosis based on physical examinations and diagnostic tests such as MRI, CT scan and imaging
Ability and use of educational CDs in patients with multimedia training
Inclination to participate in research
Having a depression score higher than 14 according to the Beck Depression Inventory
Exclusion criteria:
Unwillingness or the possibility of continuing to participate in the study for any reason (such as the severity of the pain of the patient), but also to other chronic pain such as chronic headache - chronic psychiatric disorders such as schizophrenia - participation in similar training classes - lack of participation in more than twoEducational session
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
At first, patients will be selected by available sampling method. Then, eligible patients will be assigned face-to-face and face-to-face training using random numbers in three groups of multimedia tutorials. As perpendiculars A represent multimedia tutorials, B represents a face-to-face education group and C represents a control group that will have six different modes; for example:
(1-AABBcc, 2-ABcABc, ..., 6-ABccBA
Then, to select the sample individuals, we move our finger randomly from a random point table in the direction of a row or column. Whenever there are numbers between one and six, the permutation is related to that number. For example, if number 6 arrives, the permutation of the ABCCBA is written down so that qualified patients are placed in three groups of multimedia education, face-to-face and control. The selection of permutations is repeated 15 times, so that 99 patients are assigned to three equal groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study blind people will be involved with study participants and analysts who will do the study analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Faculty of Nursing, Fatemiyeh Shiraz
City
shiraz
Province
Fars
Postal code
71345-1978
Approval date
2017-03-28, 1396/01/08
Ethics committee reference number
IR-SUMS.REC.1396.117
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Depression Score in the Beck Questionnaire-Pain severity score in pain intensity questionnaire -Disaster Scale in Pain Disaster Questionnaire
Timepoint
Before the intervention and after each intervention (7 sessions) one month after the intervention
Intervention group 1: Seven educational films will be provided to patients in seven weeks, which will be watched as a CD in the home.Intervention group 2: Face-to-face training, in which the patients fall into groups of 8 to 10 and receive training for seven weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamza clinic
Full name of responsible person
Dr. Maryam Shayegan
Street address
Nomads Street Hamza Clinic
City
Fasa
Province
Fars
Postal code
07153327273
Phone
+98 71 5331 4043
Email
R.firooziyan@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz Branch of Zand Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shayegan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz Fatemeh Nursing and Midwifery Faculty
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
R.firooziyan@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shayegan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz Namazi Square - Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
shaygan@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Maryam Shayegan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz Namazi Square, Faculty of Nursing and Midwifery, Fatemeh
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71364742548
Email
shaygan@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available