The effect of multidisciplinary and multimedia pain management education on the severity of disability in patients with chronic musculoskeletal pain and its mediating factors
Determining the effect of multidisciplinary and multimedia pain management education on the severity of disability inpatients with chronic musculoskeletal pain and its mediating factors
Design
A three-blind randomized clinical trial with a control group, pre-test-post-test design, with parallel groups. using random sequence generation software.
Settings and conduct
Clinics affiliated to Shiraz University of Medical Sciences. Intervention group will receive multidisciplinary and multimedia pain management educations and control group will receive routine educations. patients, evaluator and statistical analyzer will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age>18 years; Chronic musculoskeletal pain based on the specialist diagnosis; willingness to participate in the study; Literacy of reading, writing and speaking in Persian; Having a smart phone with WhatsApp social network; Internet access; Conscious consent.
Not including Criteria: having other chronic physical or mental diseases or other chronic pains.
Intervention groups
Patients in the control group receive routine care. In addition to routine care, patients in the intervention group receive multidisciplinary and multimedia training in chronic pain management. 7 educational contents are delivered to patients in 7 sessions. Providing educational materials to the patients of the experimental group will be in the form of sending short videos, short texts, questions and answers and group discussions through the WhatsApp application. Sessions content includes: teaching the difference between acute pain and chronic pain and how psychological factors affect the experience of chronic pain, sports exercises, effective communication and assertiveness skills, stress management, positive thinking and anger coping skills.
The effect of multidisciplinary and multimedia pain management education on the severity of disability in patients with chronic musculoskeletal pain and its mediating factors
Public title
Effect of multidisciplinary and multimedia pain management education on the disability in patients with chronic musculoskeletal pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
-Age>18 years
-Chronic musculoskeletal pain based on the specialist diagnosis
- Willingness to participate in the study
- Literacy of reading, writing and speaking in Persian
- Having a smart phone with WhatsApp social network
- Internet access
- Conscious consent to participate voluntarily in the study
Exclusion criteria:
- Having other chronic physical diseases such as cancer and MS, according to the patient's own report
-Suffering from known chronic mental illnesses, according to the patient's own report
- Having other chronic pain such as chronic headache
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, all 132 patients required to participate in the study will be selected with using the available sampling method based on visits to the office of physicians (fellowships in pain, neurology, orthopedics, spine surgery and rehabilitation) located in clinics affiliated to Shiraz University of Medical Sciences and the basis for the inclusion criteria. Then, the selected individuals will be divided into two groups of control and intervention in a completely randomly available way using randomization software. 66 patients are assigned to each study group. To do this, random sequence generation software was used. In this way, a number is assigned to each selected patient from the available sampling stage, then the numbers are entered into the software and finally, by randomly selecting the numbers by the software, it is determined that each patient will be in which group. In order to reduce the possible bias, the randomization process will be performed by the assistant researcher who will not be involved in other stages of the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the study and prevent possible bias, divided patients into two groups of intervention and control, interpretation of questionnaires, entering and analyzing data will be done by the assistant researcher and statistician out-of-study. In this way, the general introduction of the studied groups will be made for the participants, but they will be unaware of the allocation of the study groups. The evaluator and statistical analyst will not know which group’s data is interpreted or analyzed by.
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
Zavnd st.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.034
Health conditions studied
1
Description of health condition studied
chronic musculoskeletal pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain disability
Timepoint
Before, immediately and 1 month after intervention
Method of measurement
Roland-Morris disability questionnaire (MRMDQ)
Secondary outcomes
1
Description
Pain intensity
Timepoint
Before, immediately and 1 month after intervention
Method of measurement
Numeric rating scale
2
Description
Depression
Timepoint
Before, immediately and 1 month after intervention
Method of measurement
Patient health questionnaire-9
3
Description
Pain catastrophizing
Timepoint
Before, immediately and 1 month after intervention
Method of measurement
Pain catastrophizing questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: Receive seven training sessions per week including training on the difference between acute and chronic pain and how psychological factors affect the experience of chronic pain, exercise training, training of effective communication, assertiveness, stress management, positive thinking and anger coping skills.
Category
Other
2
Description
Control group: Receive routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic
Full name of responsible person
Dr Mani Ramzi
Street address
Zand st.
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 1000 3612
Email
motahari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Dr Mani Ramzi
Street address
Zand st.
City
Shiraz
Province
Fars
Postal code
71348714734
Phone
+98 71 1000 3612
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpour
Street address
Zand st.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
memarpour@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
Hajar Haghshenas
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Namazi Squre, Zand St.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
07136474254-8
Email
haghshenah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Maryam Shaygan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Namazi Square, Zand st.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
07136474254-8
Email
m2620.shaygan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Haghshenas
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Namazi Square, Zand st.
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
07136474254-8
Email
haghshenah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Unidentifiable information of patients related to the effect of educational intervention on the main variables of the study will be published, including: pain intensity, depression, pain catastrophe and pain-induced disability.
When the data will become available and for how long
1-2 months after the publication of the study results
To whom data/document is available
Researchers working in academic and scientific institutions as well as people working in industry.
Under which criteria data/document could be used
The use of study results by citing the source is not prohibited.
From where data/document is obtainable
Dr Maryam Shaygan 07136474254, Hajar Haghshenas 07136474254.
What processes are involved for a request to access data/document
The applicant can access the requested information through the mentioned email address.