Determination of the effect of palliative care methods on the pattern of life in elderly women with chronic pain
Design
This study is a pre and post interventional study.Approximately 30 individuals are sampled in an accessible sampling form among the elderly eligible to enter the study. Before starting the educational program,measuring Life style with chronic pain questionnaire in the elderly is completed by the student with the question of elderly patients with chronic pain (Before). The education program is implemented. After the completion of the education, the questionnaire is completed immediately, 1 month and 3 months after the completion of the education.
Settings and conduct
For this study samples were gathered from Mirdamad Comprehensive elderly Center.Initially, a sampling will be done in an accessible way among the elderly women with chronic pain, from the Comprehensive Centers for Elderly.
For these people, ,measuring Life style with chronic pain questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 60 and 80 years old،Elderly patients with non-malignant pain such as musculoskeletal, neuro-skeletal, neurovascular and approved by the Center's physician،The absence of mental and cognitive impairment by self-report and through the central authorities،Not attending in education course with similar topics at the same time،Absence of blindness and deafness based on physician's diagnosis.Exclusion criteria:Changes in the condition or type of treatment diagnosed by the doctor and reported by the patient،Get into the malignant diseases.
Intervention groups
For the intervention group, the palliative care package will be taught in groups of 4, 8 sessions, 2 times a week for 1 hour, 4 weeks a week. Then, at intervals of 1-3 months, follow-up is necessary .
Main outcome variables
Life style
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040988N1
Registration date:2018-10-19, 1397/07/27
Registration timing:registered_while_recruiting
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Elham Hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3217 5338
Email address
e.hesari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-15, 1397/05/24
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of palliative care education on life style with Chronic pain in Women elderly
Public title
Palliative care and life style in elderly women with chronic pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 60 and 80 years old
Elderly patients with non-malignant pain such as musculoskeletal, neuro-skeletal, neurovascular and approved by the Center's physician.
The absence of mental and cognitive impairment by self-report and through the central authorities
Not attending in education course with similar topics at the same time
Absence of blindness and deafness based on physician's diagnosis
Exclusion criteria:
Changes in the condition or type of treatment diagnosed by the doctor and reported by the patient
Get into malignant diseases
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.GUMS.REC.1397.071
Health conditions studied
1
Description of health condition studied
life style with Chronic pain in musculoskeletal disorder
ICD-10 code
M95
ICD-10 code description
Other acquired deformities of musculoskeletal system and connective tissue
Primary outcomes
1
Description
life style
Timepoint
Before intervention (pre-test) and immediate and one month and three months after intervention (post test)
Method of measurement
Life style with chronic pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for participants in the intervention group the palliative care package, according to the WHO protocol, will be trained for 4 weeks, in groups of 4 people, twice a week. The educational content included physical problems management and strategies for promoting physical activity, self-care (Diet, sleep pattern, proper use of drugs and no smoking) and psychological and spiritual care and social communication
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mirdamad elderly comprehensive center
Full name of responsible person
Mohadese Bagheri
Street address
Hosseini's impasse،Enghelab street،Mirdamad elderly comprehensive center
City
Gorgan
Province
Golestan
Postal code
4915716766
Phone
+98 17 3214 5080
Email
bagheri.zahra1@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Hesari Elham
Position
دانشجو کارشناسی ارشد پرستاری سالمندی
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3217 5338
Fax
+98 17 3245 5171
Email
e.hesari@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Shohre Kolagari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
dr.kolagari@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Hesari Elham
Position
Master Student Of Nursing Geriatric
Latest degree
Bachelor
Other areas of specialty/work
others
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
e.hesari@goums.ac.ir
Web page address
http://goums.ac.ir/
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD will be shared.
When the data will become available and for how long
6 months after publication the data files will be available.
To whom data/document is available
The data will be shared for people working in academic institutions.
Under which criteria data/document could be used
Meta analyses on data is permitted.
From where data/document is obtainable
Please contact to person responsible for scientific inquiries.
What processes are involved for a request to access data/document
The data will be available through email and researcher permission