Protocol summary

Study aim
Determine the effect of acupressure on elderly quality of life
Design
The present study is a randomized clinical trial with two groups of parallel (interventional and control) blinded patients.60 elderly people with inclusion criteria will be entered into the study with written consent,and after completing the checklist for demographic information and quality of life assessment,the samples will be divided into two groups of intervention and control using a randomized block.
Settings and conduct
For the intervention group, 12 sessions of specified pressure points, rotational massage with gentle pressure will be started taking 20 minutes to massage or pressure points, depending on the type of massage. For control group without intervention, the Lipid Quality of Life Questionnaire will be measured before and 4 weeks after the intervention. At the end of the study, two sessions of acupressure will be held for the control group and will be explained about the use of this method to improve and improve the quality of life of the elderly.
Participants/Inclusion and exclusion criteria
Entry requirements: 1. Age 60 and older 2. Not having cognitive problems using AMT questionnaire and earning score 7 and above 3. The ability to communicate verbally 4. Absence of deformity and dermatological disease in acupressure points Exit terms: 1. Use of psychiatric drugs 2. Unwilling to participate in the study
Intervention groups
Acupressure will be performed in the intervention group and the control group will receive routine care only.
Main outcome variables
Improving the quality of life, physical dimensions, self-care, depression and anxiety, social, cognitive, life satisfaction, sexual issues

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190430043436N1
Registration date: 2019-06-09, 1398/03/19
Registration timing: prospective

Last update: 2019-06-09, 1398/03/19
Update count: 0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
Hosein Jahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 0264
Email address
ho3einjahani72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acupressure on qality of life in elderly
Public title
The effect of Acupressure on qality of life in elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 and older Having no cognitive problems using the AMT questionnaire and earning score 7 and above The ability to communicate verbally
Exclusion criteria:
Deformity and skin problem at acupressure points
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment, considering that we have acupressure massage techniques, we will use the 4th block. For the 4th block, there are six different modes. So, by selecting 15 blocks of possible blocks, we will reach the equality of the two groups. With the assumption that the individuals in the a group intervention and the individuals in group b are the control group.
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 Qazvin University of Medical Sciences
Street address
Bahonar St., Qazvin University of Medical Sciences
City
qazvin
Province
Qazvin
Postal code
3471934654
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.QUMS.REC.1397.331

Health conditions studied

1

Description of health condition studied
Quality of Life
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life, physical dimensions, self-care, depression and anxiety, cognitive, social, life satisfaction, sexuality
Timepoint
The quality of life questionnaire will be completed before and after the intervention
Method of measurement
Lipad Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Performing Acupressure Techniques at 9 Points Twice in 20 Minutes in 8-12 sessions within a month.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Elderly Centers
Full name of responsible person
Hosein Jahani
Street address
Bahonar St., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3471934654
Phone
+98 28 3378 0264
Email
Ho3einjahani72@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of Qazvin University of Medical Sciences
Street address
Bahonar St., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3471934654
Phone
+98 28 3378 0264
Email
Ho3einjahani72@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Hosein Jahani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar St., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3471934654
Phone
+98 28 3378 0264
Email
ho3einjahani72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hosein Jahani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar St., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3471934654
Phone
+98 28 3378 0264
Email
ho3einjahani72@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hosein Jahani
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar St., Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3471934654
Phone
+98 28 3378 0264
Email
ho3einjahani72@gmail.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
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
Only part of the information, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
After the end of the intervention
To whom data/document is available
Researchers working in academia and other institutions
Under which criteria data/document could be used
Once the intervention is completed, it will be available
From where data/document is obtainable
Hosein jahani ho3einjahani72@gmail.com 09391427802
What processes are involved for a request to access data/document
By the end of 9.2019
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