Investigating the effect of resilience training on stress, anxiety, depression and quality of life of hemodialysis patients
Design
Study using pre-test-post-test method with control group
Settings and conduct
Due to the prevalence of depressive disorders, anxiety and stress in hemodialysis patients and the need for minimally invasive interventions, including training in these patients, this study is a group resilience training on the intervention group and pre-test and post-test with the control group on Fars-Fasa hemodialysis patients will be performed.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study were as follow: willingness to participate in the study, age 18-70 years, end-stage renal disease and under hemodialysis, a history of hemodialysis for at least 12 months or more, lack of participation in other training courses at the same time, no history of resilience training, and lack of treatement with psychotropic drugs. Patients who refused to continue their participation for any reason or were absent for more than two sessions were excluded
Intervention groups
In this study, resilience training intervention group is held in the form of 12 sessions of 90 minutes and two sessions per week by a clinical psychologist. Both pre- and post-test interventions are performed before and after the intervention.
There is no intervention on the control group, and only at the end of the study, a two-day workshop will be held to observe ethical principles.
Main outcome variables
Stress؛ Anxiety؛ Depression؛ quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047074N1
Registration date:2020-05-27, 1399/03/07
Registration timing:retrospective
Last update:2020-05-27, 1399/03/07
Update count:0
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Mehdi Amirkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 3541
Email address
amirkhani@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-06, 1399/02/17
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of resilience Training on the Quality of Life, Depression, Stress and Anxiety in Hemodialysis patients
Public title
The Effect of resilience Training on the Quality of Life, Depression, Stress and Anxiety in Hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age under 70 years
at least 12 months history of hemodialysis
no mental and physical problems
non-attending similar training classes
Exclusion criteria:
Patient dissatisfaction
Age
From 20 years old to 70 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
Block randomization method
In this study, the quadratic blocking method with a size of four was used in such a way that "training and control groups were named in groups A and B, each participant was given a short code," and two people were randomly assigned each time. Group A Two members of Group B are assigned to the four blocks, this continues until all participants are assigned to the blocks.
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
Shiraz University of Medical Sciences Ethics Committee
Street address
ZAND
City
SHIRAZ
Province
Fars
Postal code
6461797411
Approval date
2020-04-30, 1399/02/11
Ethics committee reference number
IR.SUMS.REC.1399.132
Health conditions studied
1
Description of health condition studied
Educational effectiveness
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
QUALITY OF LIFE
Timepoint
One week after training
Method of measurement
QUESTIONER
Secondary outcomes
empty
Intervention groups
1
Description
In order to develop a resilience education program, we reviewed research and resilience enhancement programs that had previously been conducted for different groups, as well as internal and external studies on resilience(29-33). Then, it was approved by the teachers of Fars University of Medical Sciences who had academic and clinical experience in this field. The intervention group received 12 sessions of training workshops on resilience skills. The control group did not receive any training during the research, but after completing it, in order to observe the principles of ethics in research, they were taught resilience content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 10 people. Training sessions were held by a clinical psychologist through lectures, discussions and group participation, modeling and role-playing, intellectual challenge, staging and homework; at the end of each session, the participants' questions were answered and the beginning of the next sessions was accompanied by a review of the topics of the previous session. In order to ensure proper productivity of the training process and also to create diversity in training, the final 10% of all training sessions were used for peer training. Peer groups are better able to encourage their peers to choose appropriate health behaviors, and they are able to share strengths and weaknesses and common experiences. Peer education is an ongoing approach in which he/she establishes a long-term friendly and intimate relationship with the patient and shares his information with him. In order to use peer education in this study, we randomly selected 3 hemodialysis patients who were not members of the participating groups. These individuals had at least one level of education with a diploma and appropriate expressiveness, had at least one year of hemodialysis experience, and according to the DASS-21 questionnaire, did not suffer from stress, anxiety and depression or were at a mild level. The training of the peers was such that in the presence of the instructor of the training program, under her supervision and guidance, they shared their experiences and strengths with the patients. Multimedia facilities such as computers, film and software players (PowerPoint) were used to provide training and to prevent tiredness in the participants; also, educational videos related to resilience, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were completed by the participants in both groups
Category
N/A
2
Description
Control group: They take the pre-test and post-test but do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina's Hemodialysis
Full name of responsible person
SHIMA SHEIDAIE
Street address
IBNSINA
City
فسا
Province
Fars
Postal code
6415421451
Phone
+98 71 5333 3541
Email
M.AMIR2006@YAHOO.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mozaffari
Street address
ZAND
City
SHIRAZ
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
MEHDI AMIRKHANI
Position
STUDENT
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO 10, RESALAT
City
FASA
Province
Fars
Postal code
7461797511
Phone
+98 71 5333 3541
Email
M.AMIR2006@YAHOO.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MEHDI AMIRKHANI
Position
INSTRUCTOR
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
RESALAT
City
FASA
Province
Fars
Postal code
7461797511
Phone
+98 71 5333 3541
Email
M.AMIR2006@YAHOO.COM
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
AMIRKHANI
Position
INSTRUCTOR
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
RESALAT
City
FASA
Province
Fars
Postal code
7461797511
Phone
+98 917 331 7818
Email
M.AMIR2006@YAHOO.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data except personal information is available
When the data will become available and for how long
unlimited
To whom data/document is available
unlimited
Under which criteria data/document could be used
EDUCATIONAL
From where data/document is obtainable
executor of plan
Mehdi Amirkhani m.amir2006@yahoo.com
What processes are involved for a request to access data/document
Send to the executor via e-mail address and receive a reply