Determining the effect of Orem's self-care program on the anxiety and sleep quality of women with breast cancer under chemotherapy
Design
In this study, 70 patients with chemotherapy-induced breast cancer who were admitted to study were available in 35 intervention groups from KhatamAnbia Hospital and 35 controls from Imam Ali Hospital in Zahedan.Apart from routine care, they will not receive special care
Settings and conduct
In this study, 70 patients with chemotherapy-induced breast cancer who were enrolled in the study were available in 35 cases of intervention group from Khatamanbia Hospital and 35 controls from Imam Ali Hospital in Zahedan. The group Controls other than routine care do not receive special care, but the intervention group falls under 3 individual training sessions
Participants/Inclusion and exclusion criteria
Start the first chemotherapy course
Age over 18 years old.
Able to communicate and collaborate
No metastasis
The absence of psychiatric illness and the use of psychosocial drugs
Gain a sleep quality score of 5 or more from the Pittsburgh Sleep Quality index
Anxiety score ranges from 32 to 75
Have at least reading and writing skills
Intervention groups
35 women with breast cancer who are chemotherapeutic and who have been admitted to the study are selected in an accessible manner.that The research units received three 30-minute training sessions, which take place individually and weekly before chemotherapy sessions.
Main outcome variables
Anxiety; Sleep quality
General information
Reason for update
Acronym
مصداق ندارد
IRCT registration information
IRCT registration number:IRCT20171009036675N3
Registration date:2018-09-01, 1397/06/10
Registration timing:retrospective
Last update:2018-09-01, 1397/06/10
Update count:0
Registration date
2018-09-01, 1397/06/10
Registrant information
Name
Fatemeh Kiani
Name of organization / entity
Faculty member, Zahedan University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
f.kiani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-04-29, 1397/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Orem's self-care program on the anxiety and sleep quality of women with breast cancer that reffring chemotherapy
Public title
The effect of Orem's self-care program on the anxiety and sleep quality of women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Start the first chemotherapy course
Be over 18 years of age
Be able to communicate and collaborate
Lack of metastasis
The presence of psychiatric illness and the use of neurology and psychiatry
Quality score sleep rating of 5 or more From the Pittsburgh Sleep Quality Index
Anxiety scores ranged from 32 to 75
At least reading and writing literacy
Exclusion criteria:
A session of absence from educational sessions
Metastasis of the disease
Patient death
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-02-05, 1396/11/16
Ethics committee reference number
IR.ZAUMS.REC1396.334
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study, 6 weeks after the intervention
Method of measurement
Spielberger Anxiety Inventory (trait and state)
2
Description
Sleep quality
Timepoint
At the beginning of the study, 6 weeks after the intervention
Method of measurement
Pittsburgh sleep quality index
Secondary outcomes
empty
Intervention groups
1
Description
Self-care education programs, with the assistance of a female educator who has a bachelor's degree in nursing, have also seen the necessary training in this regard, based on common nursing diagnosis in the stage of screening for breast cancer patients about self-care behaviors In connection with potential and Actually problems, based on the standard protocol of patient education, during the 3 weekly 25-30 non-group sessions with an emphasis on self-care in a separate department that has appropriate training conditions before starting chemotherapy and by questioning and responding And face-to-face learning and the use of pamphlets and instructional books The scholarly content of the subject will be approved by an oncologist
Category
Behavior
2
Description
Control group: Except for routine care and treatment, no intervention is given
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Fatemeh Kiani
Street address
Zahedan, Jamejam Avenue
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Web page address
http://zaums.ac.ir
2
Recruitment center
Name of recruitment center
Ali bin abe taleb hospital
Full name of responsible person
Fatemeh Kiani
Street address
Persian gulf highway.Salamat Avenue-Supplemental Hospital Ali Ibn Abi Talib
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Fkiani2011@yahoo.com
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Deputy of Research and Technology , Medical Sciences Campus , Dr. Hesabi Square, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor،faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
faculty of nursing and midwifery, Mashahir sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
f.kiani@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of nursing and midwifery, Mashahir sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
f.kiani@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fatemeh Kiani
Position
Instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of nursing and midwifery, Mashahir sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 543312498
Email
f.kiani@zaums.ac.ir
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Only the original outcome data will be available
When the data will become available and for how long
After publishing the article in 2018
To whom data/document is available
all people
Under which criteria data/document could be used
Improve treatment conditions
From where data/document is obtainable
Zahedan University of Medical Sciences
What processes are involved for a request to access data/document
Applying from the university research vice president