Assessment of the effect of a nursing intervention based on the "Roy" adaptation model on the stress, anxiety and depression of addicts undergoing treatment
Determining the effect of a nursing intervention based on the "Roy" adaptation model on the stress, anxiety and depression of addicts undergoing treatment
Design
A clinical trial with a control group, with parallel groups on 56 patients, will be used for randomization using random allocation software.
Settings and conduct
Patients hospitalized in addiction departments of Modares Hospital, Isfahan, are included in the study as available, and then they are divided into two groups of test and control using random allocation. The intervention will be carried out in the framework of the nursing process based on the "Roy" adaptation theory for the intervention group. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Addicts undergoing drug treatment admitted to addiction departments of Modares Hospital in Isfahan who are willing to participate in the study and have the ability to read and write.
Intervention groups
Intervention group: After completing the review and recognition form based on the "Roy" adaptation model by the researcher in the intervention group, the interventions will continue in the framework of the nursing process as follows:
Determining standard nursing diagnoses, determining and designing planning and goals, carrying out intervention and implementation in this step, the nurse intervenes as an external moderator and acts to expand the scope of adaptation of people and establish a compatible behavior, carry out evaluation and re-evaluation According to the review and recognition form, based on the "Roy" compatibility model, the degree of achievement of pre-specified goals and plans is re-evaluated.
Control group: receives only usual hospital care.
Main outcome variables
stress, anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N7
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of a nursing intervention based on the "Roy" adaptation model on the stress, anxiety and depression of addicts undergoing treatment
Public title
Assessment of the effect of a nursing intervention based on the "Roy" adaptation model on the stress, anxiety and depression of addicts undergoing treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Able to read and write
Consent to participate in the study
be under maintenance treatment with methadone
Exclusion criteria:
Concurrent participation in another similar study
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with size of 4. Randomization unit: individual. Randomization tool: Random allocation software. Random chain concealment is by placing patient codes in opaque envelopes.
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
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2024-07-14, 1403/04/24
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.076
Health conditions studied
1
Description of health condition studied
Drug addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
Stress
Timepoint
before and one month after the intervention
Method of measurement
Depression Anxiety and Stress Scale 21 (DASS-21)
2
Description
Anxiety
Timepoint
Before and one month after starting the study
Method of measurement
Depression Anxiety and Stress Scale 21 (DASS-21)
3
Description
Depression
Timepoint
Before and one month after starting the study
Method of measurement
Depression Anxiety and Stress Scale 21(DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the review and recognition form based on the "Roy" adaptation model by the researcher in the intervention group, the interventions will continue in the framework of the nursing process as follows: Determining standard nursing diagnoses, determining and designing planning and goals, carrying out intervention and implementation in this step, the nurse intervenes as an external moderator and acts to expand the scope of adaptation of people and establish a compatible behavior, carry out evaluation and re-evaluation According to the review and recognition form, based on the "Roy" compatibility model, the degree of achievement of pre-specified goals and plans is re-evaluated.
Category
Rehabilitation
2
Description
Control group: receives only usual hospital care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Amir Musarezaie
Street address
18 km of Isfahan-Najaf Abad road
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
musarezaie@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building number 4, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.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
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@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