Design, implementation and evaluation, the effect of Based intervention on transactional model on stress management and quality of life among dialysis patients in Tehran city (a mixed method research).
General purpose: Determining the effect of intervention based on the transactional model on the stress and quality of life of dialysis patients
Design
Semi-experimental study, with parallel groups of intervention and control, one-sided blind, sample size of 58 people in each group, randomized
Settings and conduct
Participants in this study will have dialysis patients undergoing dialysis centers in Tehran.
The location of the study will be in dialysis centers. The method of doing this study as a group training stress management based on a transectional model for dialysis patients at the center of dialysis. The study will be one Blind as patients will be unaware of being in the control group or intervention during the study.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include chronic kidney disease, Tehran residents undergoing hemodialysis, waiting for a transplant, having a case at the dialysis center, the ability to attend educational sessions, having at least a reading and writing literacy and no history of chronic psychological illness and exclusion criteria include receiving psychiatric treatment, illiterate people, and having a history of relevant training.
Intervention groups
The intervention will be based on model structures for managing stress in dialysis patients and will be tailored to the content and time required in the intervention group. The control group also receives routine training after the study.
Main outcome variables
Educational intervention; Initial assessment; Secondary evaluation; Coping efforts; Meaningful counteraction; Modulators; stress management; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180524039814N1
Registration date:2018-08-13, 1397/05/22
Registration timing:retrospective
Last update:2018-08-13, 1397/05/22
Update count:0
Registration date
2018-08-13, 1397/05/22
Registrant information
Name
Somayeh Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2250 8210
Email address
s.alizadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
empty
Scientific title
Design, implementation and evaluation, the effect of Based intervention on transactional model on stress management and quality of life among dialysis patients in Tehran city (a mixed method research).
Public title
Design, implementation and evaluation, the effect of Based intervention on transactional model on stress management and quality of life among dialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic kidney disease
Residing in Tehran
Hemodialysis treatment
Waiting for the link
Having a case at the dialysis center
Ability to attend training sessions
Have at least reading and writing skills
Not having chronic psychiatric illness
Exclusion criteria:
Getting psychiatric treatment
Uneducated people
History of related training
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
116
Actual sample size reached:
116
Randomization (investigator's opinion)
Randomized
Randomization description
a simple accident
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be randomly assigned to one of the observation or intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
School of Public Health, Campus of Shahid Sadoughi University of Medical Sciences Yazd,Anonymous Martyrs Blvd , Alam Square, Yazd.
Stress Score in Hemodialysis Patients' Stress Questionnaire
Timepoint
Before starting the study, 3 months after the study
Method of measurement
Stress questionnaire in hemodialysis patients
Secondary outcomes
1
Description
Quality Of Life Score
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Quality of life questionnaire in hemodialysis patients
Intervention groups
1
Description
Intervention group: Using educational content during eight sessions based on interactive model of Lazarus and Folkman to increase stress management in hemodialysis patients.
Category
Behavior
2
Description
Control group: During the interventions, no training was received, but after the intervention, relevant training was provided to the control group To be placed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Center Resalat
Full name of responsible person
Seyyed Hossein Lassan
Street address
Sayed Al-Shohada Clinic, next to Mosque of Seyyed Al-Shohada, Shahid Shadaki Alley,South Kerman, Resalat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1111
Phone
+98 21 2230 7961
Email
info.resalatdialysis@gmail.com
2
Recruitment center
Name of recruitment center
Dialysis Center Iranian
Full name of responsible person
Narges Sadat Zahed
Street address
P 5, Bent Bost Sarvestan, Khamis Kami, Khat Shaghaghi, , Majid Afshari (Saghdush), Heravi Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1665646314
Phone
+98 21 2632 2132
Email
info@iraniandialysis.ir
3
Recruitment center
Name of recruitment center
Parthia dialysis center
Full name of responsible person
Morteza Haji Ali
Street address
No. 287, Shahid Homayi (16th meter first south), Resalat Highway
City
Tehran
Province
Tehran
Postal code
111
Phone
+98 21 2232 7262
Email
info@partianclinic.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Central Building of Yazd University of Medical Sciences, Bahonar Square,Yazd.
City
Tehran
Province
Tehran
Postal code
1111
Phone
+98 21 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Ali Marvoti Sharif Abad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Campus of Shahid Sadoughi University of Medical Sciences Yazd, Anonymous Martyrs Blvd, Alam Square, Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 91335350374
Email
sphealth@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohtasham Ghaffari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Daneshjou Blvd, Shahid Shahriari Square,Yemeni Avenue , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
5511-198353
Phone
+98 21 2243 2040
Email
mohtashamghaffari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
somayeh alizadeh
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Campus of Shahid Sadoughi University of Medical Sciences Yazd, Anonymous Martyrs Blvd, Alam Square
City
Tehran
Province
Tehran
Postal code
8915173160
Phone
+98 919 736 5663
Email
alizade2009@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data that can be shared with the results of the original outcome is shared.
When the data will become available and for how long
Start of access after printing results
To whom data/document is available
All people are allowed
Under which criteria data/document could be used
For similar studies on dialysis disease or other chronic diseases
From where data/document is obtainable
Visit Yazd University of Medical Sciences, Faculty of Health, or email alizade2009@yahoo.com to receive the data.
What processes are involved for a request to access data/document
After submitting the application to the Yazd University of Medical Sciences, it will be available through the Library of the School of Public Health.