The aim of the present study is to determine the effect of illness perception based intervention on death anxiety and hope among hemodialysis patients. The study population is consisted of all hemodialysis patients refereed to dialysis center of Qazvin Bou-Ali hospital. In this study, 120 patients will be randomly divided into control and intervention groups. Randomization will be performed using a random numbers table. This study will be performed in dialysis center of Qazvin Bou-Ali hospital. The main inclusion criteria include having at least two dialysis sessions in a week and having no history of kidney transplant. After obtaining informed consent, demographic, illness perception, death anxiety (Templer) and hope (Herth) questionnaires will be completed by the members of two groups. No intervention will be performed in control group by researcher and patients will receive only routine care. An illness perception improving intervention will be performed for every patient (individually) in three 30-minute sessions in intervention group. An educational booklet which is collected by the researcher will be given to the patients at the end of the second session. Illness perception, death anxiety and hope questionnaires will be completed again four weeks later in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016103130609N1
Registration date:2017-01-31, 1395/11/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Marzieh Asghari
Name of organization / entity
Rajaei Cardiovascular Research Center
Country
Iran (Islamic Republic of)
Phone
+98 28 3222 4667
Email address
asghary_marzieh@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Rajaei Cardiovascular Research Center
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-02-10, 1395/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of an illness perception based intervention on death anxiety and hope among hemodialysis patients: a clinical trial
Public title
Effect of increasing illness perception on death anxiety and hope in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years old, history of dialysis at least for 12 months; having no history of kidney transplant; ability to complete the questionnaire; having no history of mental illness; having no history of loved ones death in the past few months.
Exclusion criteria: inability to answer the questions of the study; failing to answer the questions of the study due to having cognitive disease.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahid Rajaei Cardiovascular Research Center
Street address
Next to Mellat Park, Intersection of Vali Asr and Niayesh Streets
City
Tehran
Postal code
Approval date
2016-09-14, 1395/06/24
Ethics committee reference number
rhc.ac.ir.rec.1395.24
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Illness perception
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Illness perception questionnaire
Secondary outcomes
1
Description
Death anxiety
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Templer questionnaire
2
Description
Hope
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Herth hope index questionnaire
Intervention groups
1
Description
Control group: no intervention will be performed in this group by the researcher and patients will receive only routine care.
Category
Prevention
2
Description
Intervention group: An intervention, based on illness perception improvement, will be performed for each person in three 30-minute sessions in this group. An educational booklet which is collected by the researcher will be given to the patients at the end of the second session.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali-Sina Hospital
Full name of responsible person
Marzieh Asghary
Street address
Bu-Ali Sina Hospital, West Bo-Ali Street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaei Cardiovascular Research Center
Full name of responsible person
Vice Chancellor for Research, Shahid Rajaei Cardiovascular Research Center
Street address
Next to Mellat Park, Intersection of Vali Asr and Niyayesh Streets
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Cardiovascular Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaei Cardiovascular Research Center
Full name of responsible person
Dr. Tabiban
Position
Nephrologist
Other areas of specialty/work
Street address
Next to Mellat Park, Intersection of Vali Asr and Niyesh Streets
City
Tehran
Postal code
Phone
+98 21 2392 2122
Fax
+98 21 2204 2026
Email
tabiban2000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Mohammad-Ali Soleimany
Position
PHD in Nursing
Other areas of specialty/work
Street address
ُQazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Postal code
Phone
+98 912 290 1866
Fax
Email
soleimany.msn@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaei Cardiovascular Research Center
Full name of responsible person
Marzieh Asghary
Position
Msc Student in Nursing
Other areas of specialty/work
Street address
No 62, Mousa-Tabar Alley, Padegan Avenue
City
Qazvin
Postal code
Phone
+98 912 582 4069
Fax
Email
asghary_marzieh@rhc.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)