The effect of positive thinking training on stress, anxiety, depression and quality of life of hemodialysis patients: A randomized controlled clinical trial
Due to the fact that not much research has been done on the effect of psychological interventions including stress, anxiety and depression on these patients, and in order to improve the effectiveness of therapeutic interventions in these patients, this study was the first to examine the effect of positive training on stress, anxiety, depression and the quality of life of patients undergoing hemodialysis.
Design
The present study is a randomized controlled trial of clinical trials. The statistical population of this study will include hemodialysis patients . Based on the sample size formula and according to similar studies, at least 68 people (34 people in each group) were estimated, which will increase to 78 people (39 people in each group) considering the 10% probability of sample loss. Was. A randomized block method of size 4 was used for randomization.
Settings and conduct
The positive education program is based on research and positive intervention intervention programs, as well as internal and external studies in the field of positivism education. The time and place of the classes will be announced in advance to the patient, then the trainings will be scheduled by a clinical psychologist for 8 sessions. Each session will last 90 minutes. Training sessions will be in the form of lectures, group discussions, and answers.
Participants/Inclusion and exclusion criteria
Patients with chronic renal failure who are undergoing hemodialysis may not be treated with psychedelics at the same time.
Intervention groups
The positive training program was held in the form of 8 sessions of 90-minute and 2 sessions per week.
One week after the end of the intervention, quality of life questionnaires are completed by participants in both groups.
The control group did not receive any training during the research.
Main outcome variables
Quality of life؛ stress؛ anxiety؛ depression
General information
Reason for update
Acronym
PTTSADQOL
IRCT registration information
IRCT registration number:IRCT20200514047435N1
Registration date:2020-05-19, 1399/02/30
Registration timing:prospective
Last update:2020-05-19, 1399/02/30
Update count:0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
shima sheidaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 9374
Email address
sh.amir1390@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive thinking training on stress, anxiety, depression and quality of life of hemodialysis patients: A randomized controlled clinical trial
Public title
positive thinking training on stress, anxiety, depression and quality of life of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
history of participate in positive thinking training
treatment with psychotropic drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Four-dimensional block randomization
In this way, two patients from the intervention group and two patients from the control group are numbered in the four blocks and randomly assigned to the intervention and control groups, and this is done until all the blocks are finished.
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
Namazi Square, zand street
City
fasa
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.SUMS.REC.1399.133
Health conditions studied
1
Description of health condition studied
Quality of life, Stress, anxiety and depression of hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Stress score based on dass-21 questionnaire
Timepoint
One week after the intervention
Method of measurement
dass-21 questionnaire
2
Description
depression score based on dass-21 questionnaire
Timepoint
One week after the intervention
Method of measurement
dass-21 questionnaire
3
Description
anxiety score based on dass-21 questionnaire
Timepoint
One week after the intervention
Method of measurement
dass-21 questionnaire
4
Description
Quality of life based on QOL-sf36 questionnaire
Timepoint
One week after the end of the intervention
Method of measurement
SF-36 Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Positive training program was developed based on research and positive intervention programs, as well as internal and external studies in the field of positive education .The positive training program was held in the form of 8 sessions of 90-minute and 2 sessions per week. The main topics included familiarity with the meaning of positive thinking, positive and negative thinking and the role of emotions in relationships with others, awareness of one's abilities, familiarity with relaxation techniques and attention to one's strengths, as well as ability to control one's inner and outer control in dealing with problems. 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 positive thinking content in the form of a 2-day workshop. To hold the workshops, the intervention groups were divided into smaller groups of 7 people.The 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 next sessions commenced with a review of the topics of the previous session. Multimedia facilities such as computers, videos, and software players (PowerPoint) were used to provide training and prevent tiredness in the participants; also, catering and short breaks were used. One week after the end of the intervention, stress, anxiety, depression, and quality of life questionnaires were filled out by the participants in both groups.
Category
N/A
2
Description
Control group: There is no intervention on them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr and Shariati Hemodialysis Center
Full name of responsible person
Mehdi Amirkhani
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7451297420
Phone
+98 71 5333 3541
Email
Ibnsina.Hospital@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrallah Teymouri
Street address
Namazi Square - Zand Street
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
60
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
Fasa University of Medical Sciences
Full name of responsible person
Shima Sheidaie
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No10, Resalet Blvd
City
Fasa
Province
Fars
Postal code
7461797511
Phone
0098 53333541
Email
Sh.amir1390@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Shima Sheidaie
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No10,Resalat Blvd
City
Fasa
Province
Fars
Postal code
7461797511
Phone
+98 71 5333 3541
Email
Sh.amir1390@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Shima Sheidaie
Position
پرستار
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.10, Resalat Blvd
City
Fasa
Province
Fars
Postal code
7461797511
Phone
0071 53333541
Email
sh.amir1390@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available