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Ethics committees
#1
IR.AJUMS.REC.1397.262
IR.AJUMS.REC.1397.455
IR.AJUMS.REC.1397.262IR.AJUMS.REC.1397.455
Protocol summary
Study aim
Determine the effect of acupressure on the severity and perception of pain and physiological indices of male addicts in a drug addiction camps
Design
The samples are randomly assigned to two groups of intervention and control. Samples will be placed in a control group with a paired number and the number will be in the intervention group.
Settings and conduct
Intervention for 7 consecutive days and 3 times for 10 minutes each leg of each leg (5 minutes per foot) at the ST36 and SP6 points simultaneously with thumb press (a total daily dose of 30 minutes for each patient). Touch simultaneously in the intervention group and direct and deep pressure on these points for 5 minutes of pressure for each point.
Participants/Inclusion and exclusion criteria
Men aged 18 to 45
Written and informed consent to participate in the study
Lack of liver disease (ascites, hepatitis A, B, C, D)
Lack of skin disease, scarring and lack of inflammation, severe swelling and the presence of fracture in the ankle to the knee.
Having drug addiction (heroin, opium, ...)
Not having experience with acupressure.
Lack of neuropathy
Intervention groups
Touch simultaneously in the intervention group and direct and deep pressure on these points for 5 minutes of pressure for each point. In the control group, at the same time, at the points adjoining the two points, the simple touch is simple.
Main outcome variables
Determine and compare the pain and physiological indices each day before and after the intervention in the control and intervention group and are recorded in the relevant checklist.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032023N2
Registration date:2018-09-03, 1397/06/12
Registration timing:prospective
Last update:2018-10-28, 1397/08/06
Update count:2
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4323 0999
Email address
madmoli.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on pain intensity and perception and physiological indicators of male addicts in addiction retardation camp
Public title
The effect of acupressure on pain intensity and perception and physiological indicators of male addicts in addiction retardation camp
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged 18 to 45
Written and informed consent to participate in the study
Lack of liver disease (ascites, hepatitis A, B, C, D)
Lack of skin disease, scarring and lack of inflammation, severe swelling and the presence of fracture in the ankle to the knee.
Having drug addiction (heroin, opium, ...)
Not having experience with acupressure.
Lack of neuropathy
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two intervention and control groups by simple random assignment. Samples will be placed in a control group with a paired number and the number will be in the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
On the one hand, blindness means that only samples are unaware of being placed in the intervention or control group.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-07-13, 1397/04/22
Ethics committee reference number
IR.AJUMS.REC.1397.455
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
pain
Timepoint
Every day before and after intervention
Method of measurement
McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Touch simultaneously in the intervention group and direct and deep pressure on these points for 5 minutes of pressure for each point.
Category
Rehabilitation
2
Description
Control group: In the control group, at the same time, at the points adjoining the two points, the simple touch is simple.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Addiction treatment camps in Masjed Soleyman
Full name of responsible person
Farshad Siamakani
Street address
Tembi
City
Masjed Soleyman
Province
Khouzestan
Postal code
64918-53950
Phone
+98 61 3336 7543
Email
farshadsia10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush rokhafroz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
rokhafroz@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush rokhafroz
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
rokhafroz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Number 8
City
Masjed Soleyman
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 7543
Email
ymadmoli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available