World Health Organization site
Skip Navigation Links

Main
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: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2015062914463N5
Date of registration: 2015-08-31
Prospective Registration: No
Primary sponsor: Isfahan University of Medical Sciences
Public title: Effect of fordyce, s happiness program on stress, anxiety and depression of patients being treated with hemodialysis
Scientific title: Effect of fordyce, s happiness program on stress, anxiety and depression of patients being treated with hemodialysis
Date of first enrolment: 2015-06-05
Target sample size: 50
Recruitment status: Complete
URL:  http://en.irct.ir/trial/14091
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Younes Mehrabi koshki, Zahra Ghazavi   
Address:  Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave. 8174673461 Esfahan Iran (Islamic Republic of)
Telephone: +98 31 3792 7580
Email: zahra_ghazavi@nm.mui.ac.ir; y.mehrabi@gmail.com
Affiliation:  Isfahan University Of Medical Sciences
Name: Zahra Ghazavi   
Address:  Psychiatric Nursing Dep, Nursing and Midvifery Faculty, Isfahan University of Medical Sciences, Hezar Jerib Ave. 8174673461 Esfahan Iran (Islamic Republic of)
Telephone: +98 31 3792 7580
Email: zahra_ghazavi@nm.mui.ac.ir
Affiliation:  Isfahan University of Medical Sciences
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
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
Other anxiety disorders
Depressive episode
Reaction to severe stress, and adjustment disorders
Intervention(s)
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.
For other groups (placebo group) 3 sessions in the form of conversation,keeping in touch and hearing patients problems by colleague researcher individually.
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.
Behavior
Primary Outcome(s)
Stress. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
Anxiety. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
Depression. Timepoint: Before the intervention, Immediately after the intervention, One month after the intervention. Method of measurement: DASS 21 questionnaire.
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Isfahan University of Medical Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Isfahan University of Medical Sciences
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history