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The effectiveness of narrative writing on depression, Anxiety, stress, life expectancy and quality of life for hemodialysis patients compared with control group

Protocol summary

Summary
The study is a randomized clinical trial. Study Goals:Determine the effectiveness of Narrative Writing on depression, anxiety, stress,quality of life and life expectancy of hemodialysis patients;Compare the effectiveness of narrative writing with the control group on depression, anxiety, stress, quality of life and life expectancy of hemodialysis patients. Inclusion criteria: Earn equivalent score Low to moderate stress in questionnaire of depression, anxiety and stress(DASS-42);Having hemodialysis Disease for at least 6 months. Exclusion criteria:Acquisition weak stress or severe scores in the questionnaire of depression, anxiety and stress( DASS-42) ;Having physical problems that interfere in psychotherapy. Case Study Community hemodialysis patients referred to Imam Reza Hospital in Kermanshah is 1394-95 and the sample included of 28 hemodialysis patients. After sampling, They signed a satisfaction form for to participate in research. Subjects were randomly divided into two groups( an experimental group and a control group of narrative writing). The intervention group will be asked to write their feelings and experiences based on Gibbs model(What happened? What were your feelings and thoughts? What was good and bad experience? What lessons have from this situation ? What else did you do? If you could, what will happen again?) in a notebook Narrative writing for once a week for eight weeks. Study subjects complete Questionnaire depression, anxiety and stress, quality of life and life expectancy questionnaire before the first treatment session, the last session of treatment and one month after the end of treatment . Primary outcome are depression, anxiety, stress, quality of life and life expectancy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120925442N1
Registration date: 2016-01-16, 1394/10/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Akram Ahmadzadeh
Name of organization / entity
Kermanshah university of medical sience
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 4618
Email address
a.ahmadzadeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of narrative writing on depression, Anxiety, stress, life expectancy and quality of life for hemodialysis patients compared with control group
Public title
The effect of narrative writing In hemodialysis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Earn equivalent score Low to moderate stress in questionnaire of depression and anxiety and stress(DASS-42);Having hemodialysis Disease for at least 6 months;Having The age range of 20 to 55 years;Having at least a high school Education guide;Full satisfaction to participate in the research and signing Informed consent form and written Exclusion criteria:Acquisition weak stress or severe scores in the questionnaire of depression and anxiety and stress(DASS-42); Having physical problems that interfere in psychotherapy;Get psychiatric treatment or other psychotherapy at the same time;Having Signs of drug dependency in the past or present;Having Suicidal thoughts.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
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
Kermanshah University of Medical Sciences
Street address
Kermanshah. Beheshti Boulevard.Building No. 2 Medical Sciences.Deputy of research and technology.Ethics Committee
City
Kermanshah
Postal code
Approval date
2015-11-24, 1394/09/03
Ethics committee reference number
KUMS.REC.1394.185

Health conditions studied

1

Description of health condition studied
Kidney Chronic Disease
ICD-10 code
N25
ICD-10 code description
Disorders resulting from impaired renal tubular function

2

Description of health condition studied
Kidney Chronic Disease
ICD-10 code
N26
ICD-10 code description
Unspecified contracted kidney

Primary outcomes

1

Description
Narrative writing
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
Narrative writing training

2

Description
Anxiety
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
DASS-42 Questionnaire

3

Description
Stress
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
DASS-42 Questionnaire

4

Description
Depression
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
DASS-42 Questionnaire

5

Description
Quality of life
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
Quality of life Questionnaire

6

Description
Life expectancy
Timepoint
: Before the intervention, the last meeting of the intervention and one month after the end of intervention
Method of measurement
Life expectancy Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Type of intervention: narrative writing intervention program for 2 months, in eight weeks, each one meeting(The intervention group will be asked to write their feelings and experiences during dialysis treatment as the worst and most difficult experience based on Gibbs model (What happened? What were your feelings and thoughts? What was good and bad experience? What lessons have from this situation ? What else did you do? If you could, what will happen again?) in a notebook Narrative writing.)
Category
Behavior

2

Description
The control groupe don't get any treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital dialysis unit
Full name of responsible person
Masoud Ahmadi
Street address
Krmanshah.Shiroodi Boulevard. University Street.Imam Reza Hospital .dialysis unit
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciense
Full name of responsible person
Hamzeie,Kourosh
Street address
Kermanshah, shahed beheshti bulvar, Building No. 2 Medical Sciences.Research management
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciense
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
Kermanshah University of Medical Sciense
Full name of responsible person
Ahmadzadeh, Akram
Position
Master of Clinical Psychology/collegian
Other areas of specialty/work
Street address
Kermanshah, Shiroodi Boulevard - University Street - School of Medicine
City
Kermanshah
Postal code
Phone
+98 83 1427 4618
Fax
Email
ahmadzadeh.a68@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medicine Science
Full name of responsible person
Sadeghi, Kheyrollah
Position
Clinical Psychologist PhD
Other areas of specialty/work
Street address
Kermanshah, Shiroodi Boulevard - University Street - Medicine of School
City
Kermanshah
Postal code
Phone
+98 83 1427 4618
Fax
Email
Kh.sadeghi@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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