To determine the Effectiveness of Multi Disciplinary Interventions Based on Health Belief Model on Musculoskeletal Pain in the Elderly living in Nursing Homes
Design
A randomized controlled clinical trial. From each district of Tehran, two nursing homes, one for the control group and the other for the intervention group, are selected by lottery (60 people in the intervention group, 60 people in the control group).
Settings and conduct
The intervention is carried out on the elderly living in a nursing home in Tehran in the form of cluster sampling. Trainings are conducted by the training team on the intervention group. The researcher-made questionnaire is used for this study. Finally, after collecting the data, two intervention and control groups are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people aged 60 and older living in a nursing home
ability to do physical activity، ability to answer questions.
Exclusion criteria: elderly with Alzheimer's disease، elderly with mobility disabilities, and elderly who use medication to control pain.
Intervention groups
This six-month educational intervention includes three parts of physiotherapy, stress reduction and vitamin D intake, including: walking by the elderly and maintaining the correct body posture (correct exercises for standing, walking, etc which reduce the pressure on the muscles and thus reduce pain during daily activities ), the benefits and The way to take vitamin D is by a doctor and to take 50,000 units of vitamin D tablets monthly and to control stress. According to the opinion of the physiotherapist and psychologist, 4 to 6 six sessions per month (one 45-minute session each week) are held.
Control group: will not receive the educational intervention, and the follow-up of this group will be to complete the questionnaire in specific time intervals.
Main outcome variables
Musculoskeletal pains
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220904055881N1
Registration date:2023-02-11, 1401/11/22
Registration timing:registered_while_recruiting
Last update:2023-02-11, 1401/11/22
Update count:0
Registration date
2023-02-11, 1401/11/22
Registrant information
Name
Sogand Habibi
Name of organization / entity
دانشگاه تربیت مدرس
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7390
Email address
habibisogand252@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Multi Disciplinary Interventions Based on Health Belief Model on Musculoskeletal Pain in the Elderly Living in Nursing Homes
Public title
Effectiveness of Multifaceted Interventions on Reducing Musculoskeletal Pain in the Elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People Aged 60 and over Living in a Nursing Home
Ability to Perform Physical Activity
Ability to Answer Questions
Exclusion criteria:
Elderly People with Alzheimer's Disease
Elderly with Mobility Disabilities
Elderly People Who Use Medicine to Control Pain
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is cluster sampling. Tehran is divided into four regions: north, south, west, and east. The lottery method is used to select nursing homes in each region. A number is considered for each nursing home. Then the numbers are written on the paper. The papers are placed in a container and stirred well. Then two cards are selected from among the papers. The first card is considered as the intervention group and the second card as the control. Then, from each center, the elderly who meet the entry criteria are identified and selected. The sample size in each group is 60 people (60 people in the intervention group and 60 people in the control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The use of multifaceted interventions to reduce Musculoskeletal pain in the elderly is one of the innovative aspects of this plan.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University of Medical Sciences
Street address
Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.MODARES.REC.1401.111
Health conditions studied
1
Description of health condition studied
Other osteoporosis without current pathological fracture
ICD-10 code
M81.8
ICD-10 code description
Other osteoporosis without current pathological fracture
2
Description of health condition studied
Osteoarthritis, unspecified site
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
3
Description of health condition studied
Gout, unspecified
ICD-10 code
M10.9
ICD-10 code description
Gout, unspecified
Primary outcomes
1
Description
Musculoskeletal pains
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire Made by the Researcher
Secondary outcomes
1
Description
knowledge
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
2
Description
Perceived Susceptibility
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
3
Description
Perceived Severity
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
4
Description
Perceived Barriers
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
5
Description
Perceived Benefits
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
6
Description
Cues to Action
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
7
Description
Self-Efficcy
Timepoint
Before the intervention, immediately, 3, and 6 months after completing the educational intervention.
Method of measurement
Questionnaire made by the researcher
Intervention groups
1
Description
Intervention group: Physiotherapy includes training, maintaining correct body posture while standing, walking, and sitting by a physiotherapist for four to six 45-minute sessions and training walking for at least 30 minutes a day. Training reducing stress and anxiety including deep breathing, sleep regulation, etc. by a psychologist for four 45-minute sessions. Vitamin D intake includes training on how to consume vitamin D and its benefits by a doctor (every month one vitamin D tablet of 50,000 units is given to the elderly in the intervention group). the number of training sessions based on the Health belief model structures to change the beliefs of the elderly is determined based on confirmatory factor analysis. Intervention sessions will be held weekly (one session per week). The training sessions will last one to two months, but at least six months of vitamin D tablets are required to be effective, so the duration of the intervention will be six months.
Category
Prevention
2
Description
Control group: It includes elderly people living in Nursing Homes who will not receive any intervention during the research period. They will complete the questionnaire before the intervention, immediately, three and six months after the intervention. The results of this group will be compared and statistically analyzed with the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kehrizak nursing home, Shahid Rajaei office
Full name of responsible person
Hassan Ahmadi
Street address
No289., Farhadi Kia Alley., Madaan square., Nazi Abad Street
City
Tehran
Province
Tehran
Postal code
1831993134
Phone
+98 21 5505 9556
Email
info@kahrizak.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdollah zadeh
Street address
Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3502
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical sciences., Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1417113116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical sciences., Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1417113116
Phone
+98 912 287 6439
Email
tavafian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sogand Habibi
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Tehran Modares University., Nasar Bridge ., Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 918 518 1076
Email
habibisogand252@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the primary outcome can be shared.
When the data will become available and for how long
The access period will start six months after the results are published.
To whom data/document is available
Data for researchers, people working in universities and scientific institutions
Under which criteria data/document could be used
Evaluating the outcome of data analysis and verifying its correctness under the conditions of double-blindness
From where data/document is obtainable
Via email tavafian@modares.ac.ir
What processes are involved for a request to access data/document