Determining the effectiveness of aromatherapy on addicts’ desire for drugs in drug rehabilitation centers of Rafsanjan in 2021
Design
Systematic random sampling
Settings and conduct
Each of the participants will be given a black glass container, containing 1cc of 20% pure bitter orange’s essence made by Givaudan company.Participants are asked to sniff the given essence for 5 seconds. Before and after sniffing the essence, the Desires for Drug Questionnaire (DDQ) forms have to be filled by the participants without hesitation. Participants are asked to do this three times a day for three days. Meanwhile, no interventions are done in the control group.
Participants/Inclusion and exclusion criteria
1. Addict person’s agreement to be a part of the study
2. Not having psychological conditions such as psychotic or mood disorders
3. Not having epilepsy and hypertension
4. Not being allergic to bitter orange’s essence
5. Not having problems with the smelling sense
Terms of quitting the study
1. Not willing to continue with the study
2. Not doing the intervention as scheduled
3. Filling the survey form incompletely
Intervention groups
Participants are asked to sniff the given essence for 5 seconds. Before and after sniffing the essence, the Desires for Drug Questionnaire (DDQ) forms have to be filled by the participants without hesitation. Participants are asked to do this three times a day for three days. Meanwhile, no interventions are done in the control group.
Main outcome variables
Aromatherapy
Desire for Drugs
Consumed Drugs
Daily Consumption Frequency
Addiction Duration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211128053199N1
Registration date:2022-03-17, 1400/12/26
Registration timing:prospective
Last update:2022-03-17, 1400/12/26
Update count:0
Registration date
2022-03-17, 1400/12/26
Registrant information
Name
Mahin Ghiyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3418 2587
Email address
mahinghiyasi.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on the craving rate of addicts hospitalized in welfare addiction camps
Public title
the Effect of Aromatherapy on Degree of Addiction Craving
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the addict to participate in the study
No allergic reactions to spring orange essential oil
Exclusion criteria:
Having psychiatric disorders including psychotic and mood disorders
Epilepsy and high blood pressure
There is a problem with the sense of smell
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Using the systematic random sampling method, we select addicts from the list
And the lottery is randomly divided into experimental and control groups
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
Rafsanjan University of Medical Sciences (RUMS),
Street address
Emam Ali Blvd.,Rafsanjan City
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.RUMS.REC.1400.228
Health conditions studied
1
Description of health condition studied
Addicted
ICD-10 code
F11.23
ICD-10 code description
Opioid dependence with withdrawal
Primary outcomes
1
Description
consuming craving
Timepoint
Desire Material Desire Questionnaire (DDQ) immediately prior to inhalation of the relevant oil. 2- Inhale the relevant oil for 5 seconds. 3- Replenishment of Material Desire Questionnaire (DDQ) immediately after inhalation
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Participants are asked to dip their palms to a diameter of 2 cm with spring orange essential oil, which will be provided by Kashan Barij Essential Oil Company, then place their hands in front of their noses and exhale for 5 seconds after inhaling. Do. Before and after inhaling the essential oil, the participants complete the instant craving questionnaire (DDQ) and participants are asked to do this 3 times a day for 3 days.
Category
Prevention
2
Description
Control group: Addicted people hospitalized in welfare addiction treatment camps who do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Parvazi Clinic
Full name of responsible person
Mr Rezaei
Street address
Nogh Ave., Eysh Abad
City
Rafsanjan
Province
Kerman
Postal code
7736133481
Phone
+98 913 390 3580
Email
bihamta1364@gmail.com
2
Recruitment center
Name of recruitment center
Clinic Mehrvarzan
Full name of responsible person
Mr Sangi
Street address
No.6,Ansari Ave.,
City
Rafsanjan
Province
Kerman
Postal code
7713774781
Phone
+98 913 987 5255
Email
bihamta1364@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
rvazirinejad@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahinghiyasi
Position
Non-faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar Ave.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 6961
Email
mahinghiyasi.nurse@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Azam Hydarzade
Position
Faculty of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
heidarzadehaazam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahinghiyasi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
mahinghiyasi.nurse@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
No - There is not 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 data such as information about the main outcome or the like can be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic and scientific institutions, or to those who are also involved in industry.
Under which criteria data/document could be used
The use of research results in centers is unrestricted
From where data/document is obtainable
Clear contact information including mailing address for correspondence, or e-mail address, or website, and telephone and fax numbers, along with names and addresses of respondents
What processes are involved for a request to access data/document