Investigating the effect of self-care training on death anxiety in patients referred to the hemodialysis unit of Ali Ebn Abitaleb Hospital in Rafsanjan, 2023
If the positive effect of self-care on reducing the death anxiety of hemodialysis patients is observed, the results of this research can be used as a cost-effective solution without side effects and accessible and easy for patients, caregivers and therapists of hemodialysis patients.
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 50 patients was used for randomization using the random minimization method.
Settings and conduct
The place of study is in dialysis department of Ali Ibn Abitalib Hospital in Rafsanjan city. The intervention group received self-care training in three sessions and no intervention will be done in the control group.
Participants/Inclusion and exclusion criteria
Consent to participate in the study; Age above 18 years; Suffering from end-stage chronic kidney disease confirmed by a specialist doctor; Knowledge of disease diagnosis and prognosis; Alert and aware of place and time; Receive at least two dialysis sessions per week; A history of at least six months of hemodialysis; Not having known mental illness and cognitive problems to learn self-care; Not having a history of the death of loved ones in the last few months; Physical ability to do personal work.
Intervention groups
Intervention group: self-care training on death anxiety.
Control group: no intervention will be implemented.
Main outcome variables
Death anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230610058437N1
Registration date:2023-08-28, 1402/06/06
Registration timing:registered_while_recruiting
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
hananeh abbaszadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 991 498 7136
Email address
hana.abaszadeh77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-16, 1402/05/25
Expected recruitment end date
2023-09-16, 1402/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care training on death anxiety in patients referred to the hemodialysis unit of Ali Ebn Abitaleb Hospital in Rafsanjan, 2023
Public title
Investigating the effect of self-care training on death anxiety in patients referred to the hemodialysis unit of Ali Ebn Abitaleb Hospital in Rafsanjan, 2023
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Suffering from end-stage chronic kidney disease confirmed by a specialist doctor
Knowledge of disease diagnosis and prognosis
Alert and aware of place and time
Receive at least two dialysis sessions per week
A history of at least six months of hemodialysis
Not having known mental illness and cognitive problems to learn self-care
Not having a history of death of loved ones in the last few months
Physical ability to do personal work
Exclusion criteria:
Having lethargy and weakness or reduced level of consciousness
Hospitalization
Unwillingness to participate in the study
The existence of psychological problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
First, purposeful sampling based on the criteria for entering the study and qualified people in two control and intervention groups using random minimization based on the categories of death anxiety scores in the table below (in three categories, low death anxiety with a score of 0-6, moderate death anxiety with a score of 7-9 and severe death anxiety with a score of 10-15) will be assigned. The entry of the first sample in each floor is a simple random draw will be made and the next samples will be based on the total number of samples in each floor and each group.
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
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.RUMS.REC.1402.016
Health conditions studied
1
Description of health condition studied
Death anxiety in hemodialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of death anxiety
Timepoint
The measurement of death anxiety score will be before the start of the intervention and 4 weeks after the start of the self-care training intervention.
Method of measurement
Death anxiety score is measured using Templer's 15-question questionnaire in hemodialysis patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group together with a family member (the one who has the most role in patient care) in three sessions for two weeks, (two sessions in the first week and one session in the second week) for 30-45 minutes of training how to They will receive individual self-care and question and answer. During training, the control group will be separated from the intervention group and will be placed at a certain distance away from the test group. In the first session of training about the recognition of chronic kidney failure, its symptoms and complications, psychological changes in these patients, including anxiety, stress, depression and death anxiety and treatment follow-up, drugs and finally the importance of self-care in hemodialysis patients and in the second session Adherence to diet and weight control and liquid consumption, exercise and activity, sleep and rest, daily weighing and skin care (fistula) will be taught.
Category
Other
2
Description
Control group: no intervention will be implemented in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Department of Ali Ibn Abitalib Hospital
Full name of responsible person
Hananneh Abbaszadeh
Street address
Taleghani Boulevard, Ayatollah Saidi Square, Hazrat Ali Ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
aliebn_hospital@rums.ac.ir
Web page address
http://aliebn.rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Soode Khanamani Felahatipour
Street address
Rafsanjan - Imam Ali Boulevard - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 3800
Email
info@rums.ac.ir
Web page address
http://rums.ac.ir/#anchor8
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse St., Faculty of Nursing and Midwifery
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 0059
Email
hana.abaszadeh77@gmail.com
Web page address
http://nm.rums.ac.ir/#anchor4
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse Street, Midwifery Nursing School
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 0059
Email
hana.abaszadeh77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. tayebeh Negahban Bonabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Republic Blvd., Nurse Street, Midwifery Nursing School
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 0059
Email
hana.abaszadeh77@gmail.com
Web page address
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