Determination of the effect of care program based on the Roy adaptation pattern on the severity of depression, anxiety and stress in patients with colorectal cancer
Design
After obtaining written consent from the studied units, the pre-test was done by demographic form and the DASS-21 questionnaire was administered to both groups of control and intervention, and then to examine the maladaptive behaviors of the patients in the intervention group; Roy form and examination is used.
After 2 months follow-up and advice and end all the stages of intervention,The Roy follow-up care model was used;; post-test was done in both control and intervention groups and finally, data analysis was performed
Settings and conduct
Patients with colorectal cancer at Urmia Imam Khomeini Hospital in two groups of control and intervention received routine and based on the Roy adaptation pattern nursing care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definition of colorectal carcinoma of the third or fourth stage based on the patient's pathology.
Have at least 3 months to diagnose the disease.
Age of 18 to 60 years
Ability to understand training
Having the right physical and mental status to participate in the study;
The desire to participate in the study,
Lack of participation in previous care plans.
Have at least literacy and writing
The patient's lack of use of drugs to treat depression, anxiety and stress
Non-underlying disease other than cancer that affects the patient's mental status.
Exclusion criteria:
Unwillingness to participate in the study
The patient's death during the study period
Intervention groups
18 patients with colorectal cancer in intervention group received a nursing care based on Roy pattern.
18 patients with colorectal cancer in control group received usual nursing care.
Main outcome variables
depression, anxiety and stress in patients with colorectal cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160220026662N5
Registration date:2019-01-06, 1397/10/16
Registration timing:retrospective
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Nader Aghakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4816
Email address
nader1453@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2016-08-10, 1395/05/20
Trial completion date
2016-08-10, 1395/05/20
Scientific title
The effect of a care program based on Roy adaptation model of nursing on depression, anxiety and stress scores in colorectal cancer patients
Public title
The effect of a care program based on Roy adaptation model of nursing in colorectal cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definition of being colorectal cancer in the third or fourth stage based on the patient's pathology
At least 3 months have passed since diagnosis.
Age of 18 to 60 years
Ability to understand training
Having the right physical and mental status to participate in the study
The desire to participate in the study
Not participating in previous care plans
Have at least literacy and writing skill
The patient does not use drugs to treat depression, anxiety and stress
Lack of underlying illness other than cancer that affects the patient's mental status.
Exclusion criteria:
Unwilling to participate in the study
The patient's death during the duration of the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks randomization method was used to allocate individuals to groups
Blinding (investigator's opinion)
Single blinded
Blinding description
the allocation of patients to the groups was done by a nurse in the department that have no information about the treatment of A or B group.
(Hiding random allocation and staying out of the intervention group)
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
11 km of Nazlou Road, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2016-10-16, 1395/07/25
Ethics committee reference number
IR.UMSU.REC.1395.248
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
the severity of depression, anxiety and stress
Timepoint
First and 2 months after the intervention
Method of measurement
Roy review And recognition form and anxiety scale, depression, stress DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Roy follow-up care model
Category
Diagnosis
2
Description
Control group: Chemotherapy and routine nursing and medical care that are applied on a daily basis, and does not receive a training program based on the Roy adaptation pattern.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital
Full name of responsible person
Nader aghakhani
Street address
Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hazrati.a1990@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader aghakhani
Street address
Resalat Boulevard - Emergency Coy
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hazrati.a1990@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Nader aghakhani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
11 km of Nazlou Road, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7082
Email
hazrati.a1990@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader aghakhani
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
11 km of Nazlou Road, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hazrati.a1990@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader aghakhani
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
11 km of Nazlou Road, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hazrati.a1990@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The original outcome information can be shared.
When the data will become available and for how long
2019
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
By citation
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Submit the documentation request to Corresponding author and review the application and submit the documentation