The present study aimed to investigate the effect of hope therapy on depression, anxiety and stress among patients undergoing hemodialysis. This is a RCT study which 60 patients, who have entry criteria selected randomly with accidental numeric’s table, then they divided to two study and placebo groups by randomized allocation. Placebo group had 4 sessions confabulation and study group had 8 sessions hope therapy (one session per week). We used Depression, Anxiety and Stress - 21 questionnaire 3 times in study, before starting the intervention, immediate after the last session of that and 4 weeks after last session to measure the depression, anxiety and stress in patients. Finally we compare two groups variables average to characterize the differences.
General information
Acronym
hope therapy
IRCT registration information
IRCT registration number:IRCT2014031617021N1
Registration date:2014-05-09, 1393/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-09, 1393/02/19
Registrant information
Name
Maysam Rahimipour Anaraki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5490
Email address
maysam_rahimipour@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Isfahan, Vice chancellor for research
Expected recruitment start date
2013-12-26, 1392/10/05
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hope therapy program on depression, anxiety and stress of patients treated with hemodialysis in Isfahan selected hospitals in 2013
Public title
The effect of hope therapy on stress, anxiety and depression in patients treated with hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Patients age are between 18 to 65;Patients that hemodialyzes duo 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 shouldn’t participate in any complementary treatments during this study;They shouldn’t take any drug to control depression, anxiety or stress;They don’t have any intellectual or physical disability;Having full consciousness, acceptable hearing and speaking ability to answer the questions
Exclusion criteria:Absent in two or more hope therapy sessions during study;Patients who giving kidney graft or going under peritoneal dialisys;Patients who don’t like to participate in every level of study;Patients start taking drugs to control depression, anxiety and stress in order of physician;Death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjreeb Street.
City
Isfahan
Postal code
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
11/3764/د
Health conditions studied
1
Description of health condition studied
Depression, Anxiety and Stress
ICD-10 code
F43.2
ICD-10 code description
adjustment disorders
Primary outcomes
1
Description
Depression
Timepoint
Before, after and 1 month after intervention
Method of measurement
DASS-21
2
Description
Anxiety
Timepoint
Before, after and 1 month after intervention
Method of measurement
DASS-21
3
Description
Stress
Timepoint
Before, after and 1 month after intervention
Method of measurement
DASS-21
Secondary outcomes
1
Description
The effect of hope therapy program on depression, anxiety and stress
Timepoint
Before, after and 1 month after intervention
Method of measurement
DASS-21
Intervention groups
1
Description
for one group (the test group)hope therapy program for 8 weeks, one session per week (each session 1 to 1.5) by the investigator at the time of dialysis.
Category
Lifestyle
2
Description
for other groups (placebo group) to avoid errors 4 sessions a plasebo intervention by a person other individual researcher with the placebo group and mor speaks and heart listens to their problems.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
3
Recruitment center
Name of recruitment center
Zahraye Marziyeh hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences, Hezarjreeb Street.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
maysam rahimipour anaraki
Position
MSc in Nursing Education
Other areas of specialty/work
Street address
Isfahan University Of Medical Sciences, Hezarjreeb Street.
City
Isfahan
Postal code
Phone
+98 31 1792 2934
Fax
Email
maysam_ra@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Yazdani
Position
masters
Other areas of specialty/work
Street address
hezarjirib street, University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2950
Fax
Email
mohsen_yazdani@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences,College of Nursing and Midwifery
Full name of responsible person
Mohsen Yazdani
Position
masters
Other areas of specialty/work
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2950
Fax
Email
mohsen_yazdani@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)