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General information
IRCT20170514033961N2
IRCT20170514033961N3
IRCT20170514033961N2IRCT20170514033961N3
2018-01-08, 1396/10/18
2018-01-08, 1396/10/18
2018-01-08 09:16:4054
Protocol summary
Study aim
Determining the effect of cognitive-behavioral therapy on hope and fear of death in patients under hemodialysis
Design
In this randomized clinical trial, 84 included patients under hemodialysis, will be allocated into two groups of intervention and control, using stratified-block randomization sampling method.
Settings and conduct
84 included patients under hemodialysis, referring to hemodialysis centers in Ilam, will be allocated into two groups of intervention and control.
At the beginning of the study, all subjects of the two groups will be asked to complete the research questionnaires including: demographic information, Herth's hope questionnaire, and the Templer's death anxiety scale. Then, for the intervention group, the cognitive-behavioral therapies will be performed in eight one-hour weekly sessions. The control group would not receive any intervention from the researcher. After completing the intervention, Herth's and Templer's questionnaires will be completed for both group and the results will be compared with each other.
Participants/Inclusion and exclusion criteria
Entry conditions: being alert; under hemodialysis; willingness to participate in the study
No entry conditions: history of known mental disorders; history of taking any kind of psychiatric medication; history of unsuccessful kidney transplantation
Intervention groups
Intervention group: receiving cognitive-behavioral therapy for eight one-hour weekly sessions
Control group: does not receive any intervention from the researcher
Main outcome variables
Fear of death; hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170514033961N3
Registration date:2018-01-08, 1396/10/18
Registration timing:registered_while_recruiting
Last update:2018-01-08, 1396/10/18
Update count:1
Registration date
2018-01-08, 1396/10/18
Registrant information
Name
Mandana Saki
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3331 6465
Email address
m.saki@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Lorestan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral therapy intervention on hope and fear of death in patients under hemodialysis
Public title
The effect of cognitive-behavioral therapy on hope and fear of death
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
would be under hemodialysis treatment and would be willinig to participate in the study
would be alert
Exclusion criteria:
Have a history of taking any kind of psychiatric medication
Have a history of known mental disorders such as mental retardation, Alzheimer's disease, depression, psychosis, suicidal thoughts or history of suicide attempt
Have a history of unsuccessful kidney transplantation
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Samples with inclusion criteria based on stratified-block randomization will be allocated into two groups of intervention group (cognitive-behavioral therapy) and control group (without any additional intervention by researcher)
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 Lorestan University of Medical Sciences
Street address
Vice chancellor for research and technology, Lorestan University of Medical Sciences, Pardis Campus, Khorramabad-Boroujerd Road, Khorramabad, Lorestan
City
Khorramabad
Postal code
6813833946
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
LUMS.REC.1396.299
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fear of death score in Templar’s death anxiety scale
Timepoint
At the beginning of the study (before the intervention) and one week after the completion of cognitive-behavioral therapy sessions
Method of measurement
Templar’s death anxiety scale
2
Description
Hope score in Herth’s hope questionnaire
Timepoint
At the beginning of the study (before the intervention) and one week after the completion of cognitive-behavioral therapy sessions
Method of measurement
Herth’s hope questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group, after completion of the research questionnaires, will receive cognitive-behavioral therapies for eight sessions, one hour per week and then will complete the questionnaires one week after the intervention.
Category
Rehabilitation
2
Description
Control group: Individuals in this group would not receive any intervention from the researcher and they only will complete the research questionnaires at the beginning and end of the research