Protocol summary
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Study aim
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Determine the effect of acupressure on the severity and perception of pain and physiological indices of male addicts in a drug addiction camps
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Design
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This study is a single-blind randomized clinical trial using randomized permutation blocks (Block 6) (using a random permutation table).
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Settings and conduct
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Intervention for 3 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 in drug addiction camps in Masjed-Soleyman). Touch simultaneously in the intervention group and direct and deep pressure on these points for 5 minutes of pressure for each point.
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Participants/Inclusion and exclusion criteria
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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)
Having drug addiction (heroin, opium, ...)
Not having experience with acupressure.
Lack of neuropathy
Non-inclusion criteria:
skin disease, scarring and lack of inflammation, severe swelling and the presence of fracture in the ankle to the knee.
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Intervention groups
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In the intervention group, the symmetric and simultaneous touch and the direct and deep pressure on these points will be 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.
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Main outcome variables
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pain and physiological indices each day before and after the intervention in the control and intervention group
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170117032023N2
Registration date:
2018-09-03, 1397/06/12
Registration timing:
prospective
Last update:
2019-03-29, 1398/01/09
Update count:
2
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Registration date
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2018-09-03, 1397/06/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-11, 1397/06/20
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Expected recruitment end date
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2019-01-21, 1397/11/01
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Actual recruitment start date
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2018-09-11, 1397/06/20
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Actual recruitment end date
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2019-01-21, 1397/11/01
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Trial completion date
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2019-01-21, 1397/11/01
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Scientific title
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The effect of acupressure on pain intensity and perception and physiological indicators of male addicts in addiction camp
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Public title
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The effect of acupressure on pain and physiological indicators of male addicts
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
Having drug addiction (heroin, opium, ...)
Not having experience with acupressure.
Lack of neuropathy
Exclusion criteria:
Skin disease
Scarring and inflammation
Severe swelling of the foot
Fracture in the ankle to the knee
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Age
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From 18 years old to 45 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method of assigning intervention to individuals is randomized and random blocked blocks with block size 6 (using a random permutation table). The randomization list was prepared by a statistic specialist. The intervention used in this study according to a randomized list was assigned by an outside person who was not aware of the research objectives and was assigned to different diseases in the closed envelope, depending on the type of disease involved.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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On the one hand, blindness means that only samples are unaware of being placed in the intervention or control group.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-13, 1397/04/22
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Ethics committee reference number
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IR.AJUMS.REC.1397.455
Health conditions studied
1
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Description of health condition studied
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Addiction
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ICD-10 code
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Z63.72
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ICD-10 code description
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Alcoholism and drug addiction in family
Primary outcomes
1
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Description
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pain
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Timepoint
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Every day before and after intervention
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Method of measurement
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McGill Pain Questionnaire
Intervention groups
1
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Description
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Intervention group: Touch simultaneously in the intervention group and direct and deep pressure on these points for 5 minutes of pressure for each point.
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Category
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Rehabilitation
2
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Description
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Control group: In the control group, at the same time, at the points adjoining the two points, the simple touch is simple.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable