Protocol summary
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Study aim
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Determining the Effect of "Roy" Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy
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Design
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Single-blind clinical trial study, Selection of available samples from among 72 patients, Assigning samples to two groups of test and control randomly with a random number table
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Settings and conduct
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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 was done according to the inclusion criteria among patients residing in that center. The purpose and method of research was explained for the samples included in the study. Patients entered the study with informed consent.
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Participants/Inclusion and exclusion criteria
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Be able to read and write; Do not have severe physical and mental illnesses; Have the interest and satisfaction to participate in this research
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Intervention groups
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Based on the Roy adaptation model in the intervention group, after assessment and recognition, the nursing process was performed. The control group benefit from the interventions after the evaluation.
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Main outcome variables
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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
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Reason for update
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Changes considered by the Vice Chancellor for Research; Changes considered by the University Ethics Committee
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211121053121N1
Registration date:
2021-11-26, 1400/09/05
Registration timing:
prospective
Last update:
2022-04-28, 1401/02/08
Update count:
1
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Registration date
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2021-11-26, 1400/09/05
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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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2021-12-22, 1400/10/01
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Expected recruitment end date
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2021-12-24, 1400/10/03
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Actual recruitment start date
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2021-12-22, 1400/10/01
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Actual recruitment end date
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2021-12-24, 1400/10/03
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Trial completion date
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2022-03-20, 1400/12/29
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Scientific title
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Effect of Roy Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy
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Public title
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Effect of Roy Adaptation Model on the Quality of Life of People with Opioid Abuse under Methadone Maintenance Therapy
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Be able to read and write
Do not have severe physical and mental illnesses
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
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Age
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From 18 years old to 65 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:
72
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples were randomly divided into intervention and control groups with a random number table. So that the method of reading numbers by the researcher from top to bottom and even numbers were assigned to the intervention group and odd numbers to the control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Patients in the intervention and control groups did not know the difference between routine interventions and interventions in this study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The present study is a single-blind clinical trial and includes two intervention and control groups. The whole study was conducted over a period of three months. The control group was evaluated in the first month and a half and the intervention group in the second month and a half.
Ethics committees
1
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Ethics committee
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Approval date
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2021-11-13, 1400/08/22
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Ethics committee reference number
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IR.MUI.NUREMA.REC.1400.159
Health conditions studied
1
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Description of health condition studied
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Quality of Life
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ICD-10 code
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Z72.9
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ICD-10 code description
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Problem related to lifestyle, unspecified
2
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Description of health condition studied
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Opioid Abuse
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ICD-10 code
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F11.188
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ICD-10 code description
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Opioid abuse with other opioid-induced disorder
3
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Description of health condition studied
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Methadone Maintenance Therapy
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ICD-10 code
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T40.3X5D
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ICD-10 code description
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Adverse effect of methadone, subsequent encounter
Primary outcomes
1
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Description
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Quality of life in people with opioid abuse under methadone maintenance therapy
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Timepoint
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Before intervention and immediately after intervention
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Method of measurement
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Short Form (36) Health Survey
Intervention groups
1
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Description
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Intervention group: The intervention was based on the Roy adaptation model in four areas: physiological, self-perception, role-playing and independence, and belonging based on observation, interview, and measurement by the researcher. After determining the maladaptation, the interventions in the framework of the nursing process were continued as follows: 1. Determining standard nursing diagnoses that include maladaptive behaviors and behaviors that may be maladaptive in the future. 2. Planning and setting goals, in which the goals were determined on a need-by-case basis. Then the necessary nursing care to achieve the desired goals was identified. Nursing care included interventions in which the primary, underlying, and residual stimuli were modified until the primary stimulus was in the direction of individual adjustment. 3. Execution, in which the researcher acted as an external moderator to expand the scope of individual adaptation and establish a consistent behavior. The researcher changed or adjusted stimuli and conditions, not persons, thus promoting the relationship of individuals with the environment and was effective in maintaining health. At this stage, based on the needs of patients, interventions were performed individually or in groups. 4. Evaluation, in which the researcher re-evaluates pre-defined goals and plans. At this stage, the researcher examined the amount of achievement of goals and determined the degree of adaptation in the areas of health and disease.
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Category
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Rehabilitation
2
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Description
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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.
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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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Esfahan 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available