Determining the Effect of "Roy" Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy
Design
Quasi experimental study with control group, selection of available samples from among 72 patients, allocation of samples by non random based on patient file number
Settings and conduct
After receiving a letter of introduction from the Vice Chancellor for Research of Isfahan University of Medical Sciences and the management of the Article 16 Harm Reduction Center in Isfahan, sampling will be take according to the inclusion criteria among patients residing in that center. The purpose and method of research for the samples included in the study will be explained. Patients will enter the study with informed consent.
Participants/Inclusion and exclusion criteria
Be able to read and write; Have no severe physical and mental illness to participate in this study; Have more than six months of continuous opioid abuse Consumables include opiates (either alone or in combination with other drugs); Have to quit at least twice
Intervention groups
Based on the "Roy" adaptation model in the experimental group, after assessment and recognition, the nursing process will be performed. The control group will benefit from the asynchronous interventions after the evaluation.
Main outcome variables
Changing the quality of life of people with opioid abuse under methadone maintenance therapy; Changing the costs of short term and long term interventions in people with opioid abuse under methadone maintenance therapy; Changing the quality of nursing care in people with opioid abuse under methadone maintenance therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211121053121N1
Registration date:2021-11-26, 1400/09/05
Registration timing:prospective
Last update:2021-11-26, 1400/09/05
Update count:1
Registration date
2021-11-26, 1400/09/05
Registrant information
Name
Seyed Abbas Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7504
Email address
a_hoseini@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2021-12-24, 1400/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of "Roy" Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy
Public title
Assessment of the Effect of "Roy" Adaptation Model on the Quality of Life of People with Opioid Abuse
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be able to read and write
Based on his report, he should have a suitable general situation to complete the questionnaire
Have more than six months of continuous opioid abuse
Consumables include opiates (either alone or in combination with other drugs)
Have the interest and satisfaction to participate in this research
Exclusion criteria:
Try to quit opium less than twice
Has no history of using private or public addiction treatment centers
Have severe physical, mental and psychological illnesses
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study is a quantitative quasi experimental non simultaneous intervention study and includes two experimental and control groups. The whole study will take three months. The control group will be evaluated in the first month and a half and the experimental group in the second month and a half.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing, Management and Rehabilitation
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-13, 1400/08/22
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.159
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
Z72.9
ICD-10 code description
Problem related to lifestyle, unspecified
2
Description of health condition studied
Opioid abuse
ICD-10 code
F11.188
ICD-10 code description
Opioid abuse with other opioid-induced disorder
3
Description of health condition studied
Methadone maintenance therapy
ICD-10 code
T40.3X5D
ICD-10 code description
Adverse effect of methadone, subsequent encounter
Primary outcomes
1
Description
Quality of life in people with opioid abuse under methadone maintenance therapy
Timepoint
Before intervention and immediately after intervention
Method of measurement
Short Form (36) Health Survey
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher (nurse) will identify and modify environmental and individual stimuli based on the "Roy" adaptation model. At this stage, based on the needs of patients, individual interventions will be performed by the nursing process in eight two hour sessions over a month and a half. Recognition and evaluation of patients in the "Roy" adaptation model consists of two parts. In the first step, behaviors are evaluated in four areas based on observation, interview and measurement. Maladaptive behaviors are then identified. The main, underlying, and residual stimuli associated with maladaptive behaviors are then determined. After completing the assessment and recognition form based on the adaptation model "Roy" by the researcher (nurse) for the intervention group, the continuation of interventions in the framework of the nursing process will be as follows:1. Determining standard nursing diagnoses. 2. Determine and design planning and goals. 3. Performing intervention and execution, which at this stage is performed individually or in groups (individual or group activities or trainings) based on the needs of patients. 4. Perform evaluation and re-evaluation that the researcher (nurse) in this step determines the degree of adaptation in the areas of health and disease. Finally, the quality of life in the intervention group will be evaluated and re-evaluated by a self report questionnaire and its changes will be compared with the time before the start of the study in the intervention group.
Category
Rehabilitation
2
Description
Control group: After the evaluation in the intervention group, if the interventions will be useful, the necessary training, recommendations and interventions will be provided to the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Harm Reduction Center Article 16
Full name of responsible person
Soheyla Pezeshkzad
Street address
Qaleh Shor Road, south of Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8143381330
Phone
+98 31 3680 8992
Email
hcrisis1996@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hoseini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Fax
Email
a_hoseini@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hoseini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Fax
Email
a_hoseini@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Abbas Hoseini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar Jerib St., Isfahan University of Medical Sciences, School of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7504
Fax
Email
a_hoseini@nm.mui.ac.ir
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