Determining the effect of training and tele-nursing on the low back pain and disability of patients after Lumbar spine surgery
Design
Parallel group randomized trial in which participants will be divided into two groups by permuted block randomization. Sample size was calculated 72.
Settings and conduct
After referring to the neurosurgery department of 5 Azar Hospital in Gorgan, based on the admission criteria, patients who are candidate for lumbar spine surgery will be selected. After assigning informed consent, the patients will be divided into two groups based on block randomization method.Before surgery and then after surgery, at the time of discharge, the questionnaires will be completed by the participants of the both groups. After discharging from the hospital,the intervention group will receive educational multimedia through social media software twice a week during the first month and then once a week in the second month.Additionally the researcher will follow up the condition of the patients by phone call once a week . The control group will also receive routine care and education. The studied variables will be measured once at the end of the first month and second time at the the end of month 2 in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients between 18 and 64 years old, who have undergone lumbar spine surgery, speak in Persian and have the ability to use social communication software.
Exclusion criteria: non-cooperation, comorbidity, pregnancy
Intervention groups
For the intervention group after discharge from the hospital, educational multimedia will be sent individually through social communication software twice a week in the first month, and then once a week in the second month.
Main outcome variables
pain, Disability caused by back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044347N5
Registration date:2022-12-11, 1401/09/20
Registration timing:prospective
Last update:2022-12-11, 1401/09/20
Update count:0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Fatemeh Shirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
shirazifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training and telenursing on the low back pain and disability of patients after Lumbar spine surgery
Public title
The effect of training and telenursing on the low back pain and disability of patients after Lumbar spine surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of lumbar disc herniation, spinal stenosis or lumbar spondylolisthesis leading to surgery by a physicion
Lumbar disc herniation surgery during last week
Interest in participating in the study
Age between 18 and 64 years
Ability to read, write and speak in Persian
The ability to use a smart mobile phone and access to the Internet
Exclusion criteria:
Associated diseases such as musculoskeletal diseases
Having rheumatoid arthritis or ankylosing spondylitis
Pregnancy
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided into two control and intervention groups (training and tele-nursing) using random allocation with permutation block method. Then participants will be assigned to two intervention and control groups by using Random Allocation software for randomization in 12 blocks, each block with a size of 6 people.
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 Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-10-08, 1401/07/16
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.080
Health conditions studied
1
Description of health condition studied
patients after Lumbar spine surgery
ICD-10 code
G54.4
ICD-10 code description
Lumbosacral root disorders, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
before surgery, during discharge, one month after the intervention and two months after the intervention
Method of measurement
visual analog scale pain
2
Description
Disability caused by back pain
Timepoint
before surgery, during discharge, one month after the intervention and two months after the intervention
Method of measurement
Oswestry low back pain disability questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group after discharge from the hospital, educational multimedia will be sent individually through social communication software twice a week in the first 4 weeks and then once a week in the second 4 weeks. Multimedia includes text, audio, video and images, which patients use their visual and auditory senses to learn. The educational content includes necessary information regarding the surgery and the need for rehabilitation, pharmaceutical (according to the doctor's prescription) and non-pharmacological pain control methods, counseling to improve the mental and emotional state, advice regarding proper nutrition, the amount and type of activity allowed in each week, sports exercises and the use of assistive devices, and daily self-care activities (How to sit and get up, bath, toilet, etc.). The participants are requested to study the educational materials during the week and apply those materials in their daily life. Additionally the researcher will follow up the condition of the patients by phone call once a week . The control group will also receive routine care and education. The studied variables will be measured once at the end of the first month and second time at the the end of month 2 in both groups.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Educational and Therapeutic Center, Gorgan
Full name of responsible person
Mehri Mahdavi
Street address
6th Azar Ave.,5 Azar St
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3222 0561
Fax
+98 17 3222 8363
Email
pr-5azar@goums.ac.ir
Web page address
https://goums.ac.ir/index.php?slc_lang=fa&sid=104
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Hosseini
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 7282 3235
Fax
+98 71 7594 3230
Email
vcrdep@sums.ac.ir
Web page address
https://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
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shirazi_1393@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shirazi_1393@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shirazi_1393@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available