Comparison between the effectiveness of auriculotherapy and counseling based on spiritual therapy enhanced by cognitive-behavioral techniques on the pattern of substance usage among women
Comparison of the effect of auriculotherapy and enhanced spiritual counseling with cognitive-behavioral techniques on the pattern of female substance use in Kerman Women's Counseling Center in 2021
Design
A clinical trial with a control group, with parallel groups,randomized on 105 female drug users. For randomization using R software with a simple random assignment method, individuals will be divided into three groups.
Settings and conduct
First, after obtaining the code of ethics from the ethics committee of Kerman University of Medical Sciences and obtaining the code of clinical trial and presenting it to Kerman University of Medical Sciences, the researcher refers to the Kerman Women's Counseling Center with a letter of recommendation and thus prepares a list of women They will be included in the study randomly if they have informed consent and inclusion criteria. The method of random sampling will be simple. There is correction for the control group and people who perform data analysis.
Participants/Inclusion and exclusion criteria
Login: Female gender - Methadone use - Literacy - Willingness to participate in the study - Physical and mental health (no severe underlying disease) - Believer in Islam
Do not enter: Do not use methadone - Do not want to continue to participate in the study - Have any serious underlying disease - Use substances such as methadone to quit addiction at the same time
Intervention groups
The counseling group will receive 7 sessions of 90 minutes (one session per week) as a group counseling with a strengthened spiritual therapy and cognitive-behavioral approach. In this way, by stimulating the ear, it is attached to the Vakaria sids by a hand probe, and women are asked to press them every hour for one minute, except at bedtime. The control group does not receive any treatment.
Main outcome variables
Material consumption pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049164N4
Registration date:2021-12-15, 1400/09/24
Registration timing:registered_while_recruiting
Last update:2021-12-15, 1400/09/24
Update count:0
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5856
Email address
m.ghazanfarpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-10, 1400/09/19
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effectiveness of auriculotherapy and counseling based on spiritual therapy enhanced by cognitive-behavioral techniques on the pattern of substance usage among women
Public title
Comparison between the effectiveness of auriculotherapy and counseling based on spiritual therapy enhanced by cognitive-behavioral techniques on the pattern of substance usage among women under the supervision of women’s counseling center in Kerman, 2021
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a female gender
Treated with a methadone maintenance dose
Minimum literacy reading and writing
Having a personal desire and conscious satisfaction to participate in the study
Absence of severe physical illness (absence of severe underlying illness)
Lack of any significant psychiatric disorders of anxiety and depression and significant psychiatric neurological symptoms
Do not use any drugs that affect memory and cognitive function
Believing in Islam
Absence of severe cognitive disorders (Alzheimer's and dementia)
Exclusion criteria:
Use substances such as methadone to quit addiction at the same time
Absence of more than two sessions in counseling sessions
Having any severe underlying disease
Do not use a methadone maintenance dose
Reluctance to continue participating in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected in an available way and then using a simple random method by numbering people from 1 to 105 and entering the numbers into the statistical software (R). With this software, people will be divided into three groups of 35 people. It should be noted that all participants in all three groups will be addicted to drugs and all three groups will use methadone maintenance treatment. 35 people will be assigned from counseling, uriculotherapy and control groups.In the control group, in order to blind, while sticking labels on parts of the ear, the labels were gently touched to prevent any bias and also the researcher will be physically present with the people for 20 minutes but no intervention will be done. There is also blindness for people who do data analysis.
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 Kerman University of Medical Sciences
Street address
Deputy of Research and Technology.,ebne-e-Sina St.,Jahad Blvd.,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-10-18, 1400/07/26
Ethics committee reference number
IR.KMU.REC.1400.405
Health conditions studied
1
Description of health condition studied
Pattern of drug use
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
Pattern of drug use
Timepoint
ذeginning of the study (before the intervention) and at the end of the intervention
Method of measurement
Drug use pattern questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Counseling with a spiritual therapy approach enhanced by the protocol of spiritual therapy Richard and Berlin (2006) in the counseling group at the Women's Counseling Center in Kerman and by a researcher who has previously approved the authority to perform counseling by the relevant specialist. They will find that this number will be divided into 5 groups of 7 people. The consultation will take place in the form of 7 sessions of 90 minutes (once a week) as a group in a quiet place with appropriate lighting.
Category
Treatment - Other
2
Description
Intervention group 2: In the uriculotherapy group in the period without menstruation, one session per week (for 3 weeks) and a total of 6 sessions in two months in the points of my sand, nicotine, long point (lung), which includes long 1 and long 2, the thalamic point, sensory point, cerebral point, allergy point and liver point (liver) will be stimulated using a hand probe for 15 seconds and then Seyed Vakaria will be attached to the points. It is recommended to press each point for one minute. Do this every hour for one minute, except at bedtime. Do this for a week. The next week, the sidewalls will be reattached and the steps will be done again.
Category
Treatment - Other
3
Description
Control group: There will be no intervention in this group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Women's Counseling Center
Full name of responsible person
Fatemeh Esmaeili
Street address
Kerman University of Medival Science,Haft-Bagh Highway,Kerman.Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5278
Email
fateme.esmaeili1374b@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhti
Street address
Tahmasbabad cross road,Vice Chancellor for Research and Technology building
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
feteme.esmaeili1374b@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeili
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Science,Medical University Campus,Haft-Bagh Highway,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
fateme.esmaeili1374b@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masumeh Ghazanfarpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Science,Medical University Campus,Haft-Bagh Highway,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
M.ghazanfarpour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Esmaeili
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Begining of the axis of seven Alavi Garden,Campus of the University of Medical Sciences,Faculty of Nursing and Midwifery
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
fateme.esmaeili1374b@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available