Objective: To determine the effect of reminiscence therapy on cognitive disorders and depression in hemodialysis' patients. Inclusion criteria: age 25 to 75 years; ability to read; write; visual and verbal communication; lack of cognitive or chronic mental disorders; no deaths of a close family and friends in the last three months; lack of addiction to drugs abuse or alcohol; get Mini Mental State Examination (MMSE) questionnaire score 25-10. Exclusion criteria: having a history of suicidal thoughts; psychosis; mental retardation; vision and hearing problems; absence more than one session. Population under Study: hemodialysis' patients of Imam Hussein (AS) hospital and dialysis center of Red Crescent Organization in Shahrod. Sample size: A pilot study including 10 patients from each group, would determine the size of samples. Intervention group 1: participates in 12 sessions Stinson reminiscence, attended nurse and psychotherapist, for 30 to 35 minutes, twice a week. Intervention group 2: in 12 sessions for 35 to 30 minutes and twice a week talking about everyday issues with the nurse and psychotherapist. Control group: hemodialysis was done with previous process. Participants complete questionnaires of MMSE cognitive status and the Beck depression before, immediately after and one month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607186318N8
Registration date:2016-08-06, 1395/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-06, 1395/05/16
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Semnan University of Medical Seiences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reminiscence therapy on cognitive disorders and depression in hemodialysis' patients
Public title
The effect of reminiscence therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 25 to 75 years; ability to read; write; visual and verbal communication; lack of cognitive or chronic mental disorders; no deaths of a close family and friends in the last three months; lack of addiction to drugs abuse or alcohol; get MMSE questionnaire score 25-10. Exclusion criteria: having a history of suicidal thoughts; psychosis; mental retardation; vision and hearing problems; absence more than one session.
Age
From 25 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Boulvar Basij, Semnan
City
Semnan
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.SEMUMS.REC.1395.57
Health conditions studied
1
Description of health condition studied
Cognitive disorders and depression in hemodialysis' patients
ICD-10 code
F02.8
ICD-10 code description
Dementia in other specified diseases classified elsewhere
Primary outcomes
1
Description
Cognitive status
Timepoint
Before, immediately after and one month after the intervention.
Method of measurement
Variable measurement method: In this study, Cognitive status is measured by using MMSE questionnaire. Score of cognitive health (25-30), mild cognitive disorders (21-24), moderate (10-20) severe (<9). Information for each person will be recorded in a specific questionnaire for each patient.
Secondary outcomes
1
Description
Depression
Timepoint
Before, immediately after and one month after the intervention.
Method of measurement
Depression is measured by using the Beck Depression Inventory. Beck Depression Inventory tests their polls. There are a total of 21 tests of four-point scale from zero to three to respond. Scores range from zero to 63. Score and severity of depression is divided to mild (11-16), moderate (17-29) and major (30-63). Information for each person will be recorded in a specific questionnaire for each patient.
Intervention groups
1
Description
Intervention group 1, participates in 12 sessions Stinson reminiscence, attended nurse and psychotherapist, for 30 to 35 minutes, twice a week.
Category
Behavior
2
Description
Intervention group 2, in 12 sessions for 35 to 30 minutes and twice a week talking about everyday issues with the nurse and psychotherapist.
Category
Behavior
3
Description
Control group, hemodialysis was done with previous process.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein (AS) hospital and dialysis center of Red Crescent Organization in Shahrod.
Full name of responsible person
Monir Nobahar
Street address
Faculty of Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Rashidypour
Street address
Semnan University of Medical Sciences, Boulvar Basij, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor of Semnan University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 912 231 1345
Fax
Email
nobahar43@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
PhD Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
35131-38111
Phone
+98 912 231 1345
Fax
Email
nobahar43@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Nursing and Paramedical, Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
PhD Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Paramedical, Semnan University of Medical Sciences, Semnan
City
Semnan
Postal code
Phone
+98 912 231 1345
Fax
Email
nobahar43@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)