The study of educational intervention based on Lazarus and Folk man transactional model on stress and sleep quality of patients undergoing hemodialysis in Bam in 2022
Determining the effect of educational intervention based on Lazarus and Folkman's interactive model on stress and sleep quality of hemodialysis patients
Design
Clinical trial with control group, with parallel groups, without blinding
Settings and conduct
This study will be carried out on hemodialysis patients in 2022 with convenience sampling according to inclusion and exclusion criteria. The participants were divided into two random groups of intervention and the control group consist of 52 subjects for each group and there is no blinding At the beginning of the study, informed consent is obtained in writing, and the questionnaires will be given to the intervention group and the control group before the educational intervention. Then, the intervention group will have 6 training sessions (coping skills training), one session every week. Groups of 5 to 6 people will receive an educational video in the amphitheater of Pastor Hospital for one hour through mockery and group discussion, questions and answers.
Participants/Inclusion and exclusion criteria
being at least 18 years old/having an active dialysis file/having minimum reading and writing skills,
the exclusion criteria including patient unwillingness/patient death/history of chronic mental illnesses.
Intervention groups
Two dialysis centers, Pasteur and Sepehr, located in Bam city, are selected as the intervention group, and the dialysis centers of Javad Al-Aimeh in Narmashir city, Ayatollah Hashemi hospital in Reagan city, and the dialysis center in Fahraj city as the control group.
Main outcome variables
Stress
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221220056882N1
Registration date:2023-03-05, 1401/12/14
Registration timing:prospective
Last update:2023-03-05, 1401/12/14
Update count:0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
Hadis Fathalipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4431 1878
Email address
hsdisfa68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-17, 1401/12/26
Expected recruitment end date
2023-05-16, 1402/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of educational intervention based on Lazarus and Folk man transactional model on stress and sleep quality of patients undergoing hemodialysis in Bam in 2022
Public title
The study of educational intervention based on Lazarus and Folkman transactional model on stress and sleep quality of patients undergoing hemodialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old and above
having an active dialysis file
having minimum reading and writing skills
Exclusion criteria:
Refusal to participate in the study and dissatisfaction for any reason
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, for assigning participants in control or intervention groups, block randomization will be used. Thus, blocks will be created based on personal information and inside of each block will divide two equal parts, half of them will consider as intervention group and another part will
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
Ethics committee of Kerman University of Medical Sciences
Street address
Medical University Campus,Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.KMU.REC.1401.408
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
Sleep quality
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Stress
Timepoint
Before and after intervention
Method of measurement
Baldree stress questionnaire
2
Description
sleep quality
Timepoint
Before and after intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In this group, training sessions (coping skills training) in 6 sessions every week are held and consists of 5 - 6 patient in every group and for one hour through lectures and group discussions, questions and answers, educational clips in the Pastor hospital amphitheater. The educational content includes the topics of defining stress and types of stressful situations and ways to cope with it, coping skills / the concept of problem solving and the benefits of planning for problems / training in relaxation techniques / sleep disorders and sleep hygiene / training in positive thoughts technique.
Category
Other
2
Description
Control group: Patients in this group only receive routine care and questionnaires are completed by them before and after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasteur hospital
Full name of responsible person
Somayeh Alizadeh
Street address
Pasteur Hospital, Shahid Rajaie BLVD
City
Bam
Province
Kerman
Postal code
7661136987
Phone
+98 34 4431 9404
Email
pastor@mubam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Dehnaviyeh
Street address
Kerman medical sciences university, Haft Bagh highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5402
Email
rdehnavi@gmail.com
Web page address
http://kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
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
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Kerman medical sciences university, Haft Bagh highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3252 6603
Email
alizade2009@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayh Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Campus of Kerman university of medical sciences ,Haft bagh Alavi highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3252 6603
Email
alizade2009@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayeh Alizadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Kerman medical sciences university, Haft Bagh highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5402
Email
alizade2009@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
relied on secrecy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available