Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT2015062914463N5 |
Date of registration:
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2015-08-31 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of fordyce, s happiness program on stress, anxiety and depression of patients being treated with hemodialysis
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Scientific title:
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Effect of fordyce, s happiness program on stress, anxiety and depression of patients being treated with hemodialysis |
Date of first enrolment:
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2015-06-05 |
Target sample size:
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50 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/14091 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Younes Mehrabi koshki, Zahra Ghazavi
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Address:
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Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
8174673461
Esfahan
Iran (Islamic Republic of) |
Telephone:
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+98 31 3792 7580 |
Email:
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zahra_ghazavi@nm.mui.ac.ir; y.mehrabi@gmail.com |
Affiliation:
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Isfahan University Of Medical Sciences |
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Name:
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Zahra Ghazavi
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Address:
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Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave.
8174673461
Esfahan
Iran (Islamic Republic of) |
Telephone:
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+98 31 3792 7580 |
Email:
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zahra_ghazavi@nm.mui.ac.ir |
Affiliation:
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Isfahan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Patients age are between 20 to 75; Patients that hemodialyzes due to end stage renal disease; Patients that have active document in hemodialysis centers; Hemodialysis onset 3 months at least; Hemodialysis do with sodium bicarbonate 3 times a week; They should not participate in any complementary treatments during this study; They should not take any drug to control depression, anxiety or stress; They do not have any intellectual or physical disability; Having full consciousness, acceptable reading and writing ability to answer the questions
Exclusion criteria:Absent in two continuous fordyce s happiness sessions during study; Patients who giving kidney graft or going under peritoneal dialysis; Patients who do not like to participate in every level of study; Patients start taking drugs to control depression, anxiety and stress in prescribed by physician; Death
Exclusion criteria:
Age minimum:
19 years
Age maximum:
75 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Condition 1: Mental and behavioural disorders. Condition 2: Mental and behavioural disorders. Condition 3: Mental and behavioural disorders. Other anxiety disorders Depressive episode Reaction to severe stress, and adjustment disorders
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Other anxiety disorders
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Depressive episode
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Reaction to severe stress, and adjustment disorders
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Intervention(s)
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For study group had Fordyce s happiness program for 6 weeks, one session per week (each session 20 min) by the researcher at the time of hemodialysis.
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For other groups (placebo group) 3 sessions in the form of conversation,keeping in touch and hearing patients problems by colleague researcher individually.
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Intervention 1: For study group had Fordyce s happiness program for 6 weeks, one session per week (each session 20 min) by the researcher at the time of hemodialysis. Intervention 2: For other groups (placebo group) 3 sessions in the form of conversation,keeping in touch and hearing patients problems by colleague researcher individually.
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Behavior
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Primary Outcome(s)
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Stress. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
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Anxiety. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
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Depression. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
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Source(s) of Monetary Support
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Isfahan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Isfahan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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