Although Kidney transplant as an alternative treatment can increase life expectancy and improve the quality of life of patients with end-stage kidney function ,it is associated with a lot of mental stress and psychiatric co-morbidity for these patients. The aim of this study is to evaluate of expressive emotion effect on physical and mental health of kidney transplantation recipients. In this clinical trial transplant recipients randomly will divide into two intervention and control groups and respectably will receive expressive emotion therapy and daily recording method as placebo. Effect of these methods on quality of life, general health, anxiety, depression and medical complications will be assessed by Hospital Anxiety Depression Scale(HADS), General Health Questionnaire(GHQ) and Kidney Transplant Questionnaire(KTQ) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111625063N1
Registration date:2016-01-11, 1394/10/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-11, 1394/10/21
Registrant information
Name
Arvin Hedayati
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2421
Email address
hedayatia@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of expressive emotion intervention effect on physical and mental health of kidney transplant recipients
Public title
Evaluation of expressive emotion intervention effect on physical and mental health of kidney transplant recipients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusive criteria: Patients under kidney transplantation; During 1st week after transplant; Age >18 years old; With ability of writing and reading in Farsi.
Exclusive criteria: No interest for participation in this study; Patients with prominent cognitive or psychiatric problem that limit their ability for participation in this study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences
Street address
The Ethics Committee of Tehran University of Medical Sciences,Tehran University of Medical Sciences,Tehran , Iran
City
Tehran
Postal code
Approval date
2015-08-29, 1394/06/07
Ethics committee reference number
IR.TUMS.REC.1394.661
Health conditions studied
1
Description of health condition studied
Moderate Depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode Four or more of the above symptoms are usually present and the patient is likely to have great difficulty in continuing with ordinary activities.
Primary outcomes
1
Description
Depression
Timepoint
1st and 3th month after intervention
Method of measurement
Questionnaire
2
Description
Anxiety
Timepoint
1st and 3th month after intervention
Method of measurement
Questionnaire
3
Description
Quality of life
Timepoint
1st and 3th month after intervention
Method of measurement
Questionnaire
4
Description
Medical complication
Timepoint
1st and 3th month after intervention
Method of measurement
History taking
5
Description
General health
Timepoint
1st and 3th month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention for target group is expressive emotion therapy. During the first week after transplantation the target group will be asked to do homework in three 15 minutes sessions.
How to write the contents of the cases will be as follows: What you are being asked to write, as the most profound ideas, your feelings about the experience kidney failure and transplants. I know people who are undergoing a kidney transplant, experiencing many emotions and you want to focus on all of these emotions. Discover your deepest feelings and thoughts. You may have different feelings and changes before the diagnosis of kidney failure, during dialysis, when you were in waiting list and now. Each of the courses you choose is important to focus entirely on your deepest feelings and thoughts. I mention again you must focused on the deepest feelings and thoughts. The only rule is continuous writing for 15 minutes. If you feel that you have nothing to give, just repeat the previous entries that have said. About the mistakes of grammar, spelling and sentence do not apply. Just write.
After the meetings about the content of the supportive feedback is given by the clinician.
Category
Behavior
2
Description
The control group will be asked to focus only on the facts of renal failure and kidney transplantation, not on their emotions ,during three 15 minutes sessions.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Arvin Hedayati
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences ,Deputy of Research and Technology
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Arvin Hedayati
Position
Fellowship Assistant
Other areas of specialty/work
Street address
Department of Psychosomatic Medicine. Imam Khomeini Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2421
Fax
Email
hedayatia@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Ali Noorbala Tafti
Position
Full Professor
Other areas of specialty/work
Street address
Department of Psychosomatic Medicine. Imam Khomeini Hospital, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 6119 2421
Fax
Email
noorbala1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Psychosomatic Medicine. Imam Khomeini Hospital, Tehran, Iran
Full name of responsible person
Arvin Hedayati
Position
Fellowship Assistant
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6119 2421
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)