Designing and evaluation of a theory-based educational intervention to change damaging behaviors to vertebra among staff who transfering patients in hospital
Objectives: This study aime to evaluate the designed educational program based on social cognitive theory to change damaging behaviors to vertebra of nurses caring/ transferring patients working in Qom hospitals of Iran.
Design: This program will be tested in a clinical trial in which 120 eligible staff who transfering patients in two groups of intervention and control will participate
Setting and conduct:To select participants, firstly from all hospitals located in Qom city, two hospitals affiliated to Qom University of Medical Sciences in city of Qom will be selected randomly and then randomly will be divided into either to control or intervention hospital.
Participants including major eligibility criteria: having been care workers for at least one year, being aged 18-60 years, and suffering from chronic low back pain
(CLBP) due to mechanical forces for more than 90 days. However patient-care workers who reporte suffering from infection in their vertebra, having myofascial back pain, spinal stenosis or recent vertebral fracture, or a history of surgery on the vertebra during the past two years of the study initiation will not enter into the study.From intervention hospital 63 eligible nurses' aides and from other hospital 62 eligible nurses' aides who will be satisfied to enter into the study were selected
Intervention: The participants in intervention hospital will be received four 2- hour multidisciplinary educational intervention consisted of social cognitive theory based educational program and ergonomic posture training in two working days
main outcome measures:Low back pain (LBP) intensity and disability reduction are the outcomes and will measure through Visual Analogue Scale (VAS), and Quebec Disability Scale (QDS) in three times of before intervention and immediately after and 6 months after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090618022N2
Registration date:2016-12-21, 1395/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-21, 1395/10/01
Registrant information
Name
Sarallah Shojaei
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3772 2154
Email address
sarallah.shojaei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for research of Tarbiat Modares University
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2017-03-01, 1395/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluation of a theory-based educational intervention to change damaging behaviors to vertebra among staff who transfering patients in hospital
Public title
Designing and evaluation of a theory-based educational intervention to change damaging behaviors to vertebra among staff who transfering patients in hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:having been care workers for at least one year, being aged 18-60 years, and suffering from chronic low back pain (CLBP) due to mechanical forces for more than 90 days
Exclusion: who reported suffering from infection in their vertebra, having myofascial back pain, spinal stenosis or recent vertebral fracture, or a history of surgery on the vertebra, participate in exercise programs and nutritional and other physical therapy at the same time
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
125
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 in Tarbiat Modares University
Street address
gisha paul
City
Tehran
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
IR.TMU.REC.1394.15
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Acute or chronic pain in the lumbar or sacral that may strain or sprain a muscle or movement Ligament- spine and other related conditions
Primary outcomes
1
Description
Chronic low back pain
Timepoint
6 month following end of intervention
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Chronic Low Back Pain Preventive Behaviors
Timepoint
6 month following end of intervention
Method of measurement
low back pain preventive behaviors questionnaire
Intervention groups
1
Description
educational program included four 2-hour education/practice sessions as follows:
Promoting self-efficacy of the participants in complying with ergonomic posture
Promoting self-regulation of the participants regarding complying with ergonomic posture
Highlighting outcome expectations of maintain ergonomic posture of vertebra
Focusing on emotional coping with maintaining ergonomic posture of vertebra in
workplace
Category
Prevention
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals nekoei and shahid beheshti dependent Qom university of medical sciences
Full name of responsible person
mahdi safa
Street address
taleghani street
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for research of tarbiat modares university
Full name of responsible person
Dr movahedin
Street address
gisha paul
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for research of tarbiat modares university
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Health Education & Health Promotion, Faculty of Medical Sciences, Tarbiat Modares Univ
Full name of responsible person
Sarallah Shojaei
Position
Ph.D in health education and promotion
Other areas of specialty/work
Street address
gisha Paul
City
Tehran
Postal code
Phone
+98 25 3711 8304
Fax
Email
sarallahshojaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
sarallah shojaei
Position
Ph.D in health education and promotion
Other areas of specialty/work
Street address
Nekoei hospital
City
Qom
Postal code
Phone
+98 25 3711 8304
Fax
Email
sarallahshojaei@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)