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the effect of acupressure on pain and activity of daily living (ADL) among older adults women in day care centers

Protocol summary

Study aim
Determining the effect of acupressure on pain and daily life activities of elderly women in Qazvin daily care centers
Design
Study of semi-experimental clinical trial of continuous sampling method
Settings and conduct
Samples will be reviewed in terms of entry criteria, and then a personal profile form as well as assurance of non-cognitive impairment in front of research samples, VAS pain scales, and ADL daily life activities will be completed. Samples of all elderly women with chronic pain will be selected and 80 elderly women will be selected by continuous sampling and will be randomly divided into two test groups and control. First, the visual acuity scale and daily activity activity questionnaire measure the intensity of pain and daily activity activity in both groups. For the intervention group, 10 sessions three days a week, according to pressure points (LIV3, UB62, SP9 , GB34, UB17, GB30, UB25-UB11, GB20, GB21), massage or pressure is started in a circular motion for about 10 minutes and the pressure is tolerated by the thumb for 1 minute for each point. In the control group intervention will be ineffective. Pain and daily activities of life in both groups one week after the end of the 10 sessions will be evaluated as a post-test.
Participants/Inclusion and exclusion criteria
chronic pain for at least 3 months Get a score of 4 or higher on the VAS scles
Intervention groups
In this study, the sample of research is the elderly women who have a file in the day care centers for the elderly in Qazvin and will have the criteria to enter the following research.
Main outcome variables
reducing pain and increasing daily life activities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200427047217N1
Registration date: 2020-05-19, 1399/02/30
Registration timing: prospective

Last update: 2020-05-19, 1399/02/30
Update count: 0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Farzaneh Mehdipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3356 3071
Email address
mehdipour.farzaneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of acupressure on pain and activity of daily living (ADL) among older adults women in day care centers
Public title
the effect of acupressure on pain and activity of daily living
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Persistent chronic pain for at least the last three months Average pain score (score 4 or higher than VAS pain scles) Absence of mental disorder Non-smoking, alcohol and drugs Do not use neuroleptic drugs
Exclusion criteria:
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling first as a random stratum, referring to 4 daily aging centers and selecting 80 elderly people from these centers (20 people from each center) For random allocation, we will use a double block that we have 4 modes (aa, bb, ab, ba) and by selecting 40 times from the possible blocks we will reach an equal volume of two groups. Assuming that people a test group and b control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
No 13,sarary Ave,Rahahan Street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34177-39659
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.IUMS.REC.1398.1227

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Activities of daily living
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reducing pain and reducing the score of the visual pain scles questionnaire
Timepoint
before the intervention and one week after the end of the 10session
Method of measurement
Visual Analogue Scale

2

Description
The probability of increasing the activity daily of life and increasing the score of the Bartel activity daily questionnaire
Timepoint
before the intervention and one week after the end of the 10session
Method of measurement
Activities of daily living

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: apply acupressure in Ten effective points where each point of massage is analyzed for one minute. This work continues for ten sessions
Category
N/A

2

Description
Control group: Use of ineffective acupressure in 9 ineffective points (sham) where each point is tolerated for one minute of massage. This work lasts for ten sessions
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Day care centers for the elderly in Qazvin
Full name of responsible person
Farzaneh Mehdipour
Street address
All day care centers for the elderly in Qazvin
City
Qazvin
Province
Qazvin
Postal code
34177-39859
Phone
+98 28 3356 3071
Email
mehdipour.farzaneh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Khairkhah
Street address
Iran University of Medical Sciences, next to Milad Tower,Hemmat Highway,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4365 1708
Email
kheirkhah.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Mehdipour
Position
Senior students
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences,above Mirdam,Valiasr St,Tehranad, Rashid Yasemi St,
City
Tehran
Province
Tehran
Postal code
19395/ 4798
Phone
+98 21 4365 1820
Email
mehdipour.farzaneh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faride Bastani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences,above Mirdam,Valiasr St, Rashid Yasemi St,Tehran
City
Tehran
Province
Tehran
Postal code
19395/ 4798
Phone
+98 21 4365 1820
Email
Bastani.f@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Mehdipour
Position
Senior students
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Iran University of Medical Sciences,Rashid Yasemi ,above Mirdamad,St,Valiasr St,Tehran
City
Tehran
Province
Tehran
Postal code
19395/ 4798
Phone
+98 21 4365 1820
Email
mehdipour.farzaneh@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
To use data in your studies
From where data/document is obtainable
Farzaneh Mehdipour mehdipour.farzaneh@yahoo.com
What processes are involved for a request to access data/document
After these documents reached the university approval stage, an article was published.
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