The effect of pain management education on severity of pain, anxiety and disability after lumbar surgery in patients with chronic low back pain referred to hospital
Determining the effect of pain management training on pain intensity, anxiety and disability after the low back pain in patients with chronic low back pain referring to Chamran Hospital in Shiraz,
Design
This study is a parallel controlled clinical trial (RCT) study that examines the effectiveness of pain management training on pain intensity, anxiety and disability in patients undergoing lower back surgery in Chamran Hospital of Shiraz.Patients are divided into intervention and control groups.
Settings and conduct
Sampling was randomly selected from patients eligible for surgery in Chamran Hospital, 70 people. They were randomly assigned to control and intervention groups using randomized software. Chamran Hospital affiliated to Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Individuals aged 70-30.
Existing chronic pain more than 3 months before surgery based on expert diagnosis.
In the past 8-4 weeks, surgery has been performed on the stenosis of the spinal cord and the intervertebral disk.
The possibility of participating in educational interventions based on the opinion of the surgeon.
Having at least literacy (reading and writing).
Willingness to participate in research and complete informed consent form
Intervention groups
Pain management training is given to patients in the intervention group twice a week during 7 sessions of 60-90 minutesAnd the control group receives only routine treatment and does not receive any training.
Main outcome variables
Determine and compare the mean of severity of pain, anxiety, disability before, immediately and 3 months after the intervention in the intervention and control groups of the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180310039021N1
Registration date:2019-03-04, 1397/12/13
Registration timing:retrospective
Last update:2019-03-04, 1397/12/13
Update count:0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Mahsa Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3840 2412
Email address
zamanimah@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pain management education on severity of pain, anxiety and disability after lumbar surgery in patients with chronic low back pain referred to hospital
Public title
The effect of pain management education on severity of pain, anxiety and disability after lumbar surgery in patients with chronic low back pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals aged 70-30.
Existing chronic pain more than 3 months before surgery based on expert diagnosis.
In the past 8-4 weeks, surgery has been performed on the stenosis of the spinal cord and the intervertebral disk.
The possibility of participating in educational interventions based on the opinion of the surgeon.
Having at least literacy (reading and writing)
Willingness to participate in research and complete informed consent form
Exclusion criteria:
Participate in previous studies
Absence in training sessions more than 2 sessions
Cases of other chronic diseases unrelated to patient pain
Having mental disabilities such as schizophrenia
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using a random number table so that after determining the exact number of people in the community each is coded in each order. Then, randomly, from a table point in the direction of a row or column, randomly begins choosing by computer
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
No.181,10Th Mikhak, Mikhak Ave, Mianrod Town
City
shiraz
Province
Fars
Postal code
7179716974
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.SUMS.REC.1397.003
Health conditions studied
1
Description of health condition studied
Spinal cord stenosis and Disk Herniation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety Score in PASS pain anxiety inventory and Disability score in Oswestry questionnaire and Severity of pain in the numerical scale of pain
Timepoint
Before the intervention begins.After the intervention.Three months later
Patients are divided into two groups: intervention group: Patients in this group receive pain management training at 7 sessions of 60-90 minutes twice a week. It should be noted that the training of the physical activities necessary for the patient will be carried out by a physical therapist and with the advice of the surgeon, based on the type of injury and type of surgery. In each training session, firstly review the contents of the session before and answer the possible questions of the patients. It will be given. Immediately after the training sessions and three months later, the above questionnaires were completed again .
Category
Lifestyle
2
Description
Control group: Only routine care is performed without additional work, and the questionnaire is completed first and again 3 months later by the patients in this group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Syed Ali Hashemi
Street address
Chamran Blvd
City
shiraz
Province
Fars
Postal code
7179615243
Phone
+98 71 3624 0101
Email
Chamranhosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Bahador
Street address
Zand Ave
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
president@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
50
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
Maryam Shaygan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nursing school.Namazai Square.Zand Street
City
shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shayganm@sums.ac.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
nursing school.Namazai Square.Zand Street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shayganm@sums.ac.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Zamani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No181. 10Th. mikhak Ave.Arghavan street. Mianrod Town
City
Shiraz
Province
Fars
Postal code
7179716974
Phone
+98 71 3840 2412
Email
zamanimah@sums.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
Confidentiality of patient information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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