Determining the effect of sleep hygiene program implementation on self-care behavior of heart failure patients admitted to Qaim Firozabad Hospital in 2023
Design
The sample size in this study is 74 people who are divided into two intervention and control groups by simple random method using Kitset software.
Settings and conduct
Patients admitted to Qaim Firozabad Hospital and discharged from the CCU department are placed in two groups, and the sleep health program consists of five one-and-a-half-hour sessions, three of which are face-to-face in the heart failure clinic and two in eiTA Messenger.
Participants/Inclusion and exclusion criteria
The participants are heart failure patients
Inclusion criteria:
- At least one year has passed since the patient's heart failure diagnosis.
- Heart failure patients of class two or three
- Nativeness of heart failure patients
-Being in the age group of 35 to 55 years
- No use of sedative or hypnotic drugs at the time of entering the study
- The ability to perform self-care
- No consumption of alcoholic beverages and drugs
- Expression of having sleep problems
Exit criteria:
- Death of the patient
-Death of family members or other first degree relatives during the implementation of the study
Intervention groups
Depending on the intervention of sleep hygiene education and strengthening of self-care behaviors
in the control group of routine discharge training
Main outcome variables
Management and promotion of self-care in heart failure patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231030059902N1
Registration date:2024-01-20, 1402/10/30
Registration timing:retrospective
Last update:2024-01-20, 1402/10/30
Update count:0
Registration date
2024-01-20, 1402/10/30
Registrant information
Name
Hasan Allahyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3873 5374
Email address
allahyari814@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementation of sleep hygiene program on self-care behavior of patients with heart failure
Public title
Investigating the effect of implementation of sleep hygiene program on self-care behavior of patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed since the patient's heart failure diagnosis
Class II or III heart failure patients
Nativeness of patients with heart failure
Being in the age group of 35 to 55 years
Not taking sedative or hypnotic drugs at the time of entering the study
Having the ability to communicate and being literate
Ability to perform self-care
No consumption of alcohol and drugs
Not having other chronic physical and mental disorders, including chronic kidney failure, liver failure, diabetes, or mental disorders such as major depression and other psychotic disorders.
Claim to have sleep problems
Exclusion criteria:
death of the patient
The death of family members or other first -class relatives during the study of the study
Taking sedative or sleeping medications during intervention
The creation of any adverse event that causes the patient's severe stress and anxiety at the time of study
The patient's unwillingness to continue studying or not attending educational sessions for more than one session
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the study tool by each patient; In the next step, by giving an identification code to each of the patients and using a subsidized random selection software (random number generation kit set online), the patients participating in the study are assigned to two control and intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All stages of the sleep hygiene program are performed using a comprehensive sleep hygiene booklet designed by myself, and the patient has a dynamic role in the program.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Jahrom University of Medical Sciences
Street address
5th floor, unit 27, Reza building, next to Afar Korosh street, Firozabad, Fars province, Iran
City
Firoozabad
Province
Fars
Postal code
7471643875
Approval date
2023-12-27, 1402/10/06
Ethics committee reference number
IR.JUMS.REC.1402.099
Health conditions studied
1
Description of health condition studied
Heart failure disease
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
self care
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Jarsma's European questionnaire of self-care behaviors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the intervention group, a notebook titled "Comprehensive Sleep Health Program Notebook" was prepared by the researcher, which includes five training sessions for five weeks, three sessions are held in person and two sessions are held virtually in Iranian ETA messengers. Necessary trainings are provided and Questions and answers will be held and educational sessions will include: explanation and explanation of the phenomenon of sleep and its role in health and illness, familiarization with various types of sleep disorders and improving factors, sleep quantity and quality Daily stress management and spiritual interventions improve sleep, and face-to-face training sessions are conducted using comprehensive sleep hygiene booklets, video projectors and slides, and virtual sessions using text, video, and podcasts.
Category
Lifestyle
2
Description
Control group:There is no intervention and they receive routine training during discharge, and if the interventions performed on the intervention group are effective, all the training will be given to the control group at the end of the research.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Firozabad Hospital
Full name of responsible person
Hasan Allahyari
Street address
5th floor, unit 27, Reza building, next to Afar Korosh street, Firozabad, Fars province, Iran
City
Firoozabad
Province
Fars
Postal code
7471643875
Phone
+98 905 868 5597
Fax
Email
allahyari814@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Amir Abdoli
Street address
Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 912 714 4223
Email
a.abdoli25@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Hasan Allahyari
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
5th floor, unit 27, Reza building, next to Afar Korosh street, Firozabad, Fars province, Iran
City
Firoozabad
Province
Fars
Postal code
7471643875
Phone
+98 71 3873 5374
Email
allahyari814@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Rasol Eslamiakbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom University of Medical Sciences،Jahrom،Fars Province,Iran
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Fax
+98 71 5444 0823
Email
eslamiakbarrasool@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Hasan Allahyari
Position
Nursing Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
5th floor, Unit 27, Reza building, Next to Afar Korosh street, Firozabad, Fars province, Iran
City
Firoozabad
Province
Fars
Postal code
7471643875
Phone
+98 71 3873 5374
Email
allahyari814@gmail.com
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