The effect of cognitive emotional intervention on post traumatic stress and growth, sleep quality and anxiety in hemodialysis patients
Design
Samples will be randomly assigned to the intervention and control groups.
Settings and conduct
Samples will be randomly assigned to the intervention and control groups. Both groups will be pre-tested by completing questionnaires on post-traumatic growth, post-traumatic stress, anxiety and sleep quality. The intervention group will receive 5 sessions of emotional cognitive training program in two sessions per week in groups of 4 to 8 people based on the specified content. After 12 weeks, the research questionnaires will be completed again as a post-test by going home or being in the ward. During this period, the control group will not receive any program other than the usual treatment program. Their case is also done.
Participants/Inclusion and exclusion criteria
Entrance: Lack of concurrent training program, Literacy for reading and writing
No Entrance: Do not attend or miss more than one session in the training program
Intervention groups
The intervention group will receive 5 sessions of emotional cognitive training program in two sessions per week in groups of 4 to 8 people based on the specified content. After 12 weeks, the research questionnaires will be completed again as a post-test by going home or being in the ward. During this period, the control group will not receive any program other than the usual treatment program. Their case is also done.
Main outcome variables
Emotional Cognition, Growth, Post Traumatic Stress, Sleep Quality, Hemodialysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150423021904N4
Registration date:2021-11-05, 1400/08/14
Registration timing:prospective
Last update:2021-11-05, 1400/08/14
Update count:0
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Fatemeh Mahmoudi Kohani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 854 3127
Email address
f.mahmodi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive emotional intervention on post traumatic stress and growth, sleep quality and anxiety in hemodialysis patients
Public title
Effect of cognitive emotional intervention on post traumatic stress and growth, sleep quality and anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of concurrent training program
Be literate
Exclusion criteria:
Absence or absence from more than one session in the training program
Patient's critical condition
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly assigned to intervention and control groups. First, the total number of subjects enrolled in the envelope containing the study groups (A intervention and control B) was prepared and randomly sorted. Gradually, by identifying the eligible person, one of the envelopes was allocated to the selected individuals, respectively.
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 Bam University of Medical Sciences
Street address
Shahid Rajaie Blvd., Bam university Of Medical Sciences & Health Services
City
Bam
Province
Kerman
Postal code
7661771967
Approval date
2019-11-17, 1398/08/26
Ethics committee reference number
IR.MUBAM.REC.1398.093
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
F43.10
ICD-10 code description
Post-traumatic stress disorder, unspecified
Primary outcomes
1
Description
Post traumatic stress
Timepoint
Assessing post traumatic stress before and after the intervention
Method of measurement
Post traumatic stress questionnaire
2
Description
Post traumatic growth
Timepoint
Assessing post traumatic growth before and after the intervention
Method of measurement
Post traumatic growth questionnaire
3
Description
Sleep quality
Timepoint
Assessing sleep quality before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
4
Description
Anxiety
Timepoint
Assessing anxiety before and after the intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive 5 sessions of emotional cognitive training program in two sessions per week based on the specified content.
Category
Behavior
2
Description
Control group: They do not receive a plan other than the usual treatment plan.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bam Pastour Hospital
Full name of responsible person
Fatemeh Mahmoudi
Street address
Pastor Hospital., Persian Gulf Blvd., Bam-Baravtat Road., Bam
City
Bam
Province
Kerman
Postal code
76197745
Phone
+98 34 4431 9403
Email
mahmodi2020@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Dr Sajad Khosravi
Street address
Bam University of Medical Science., Shahid Rajaiee Blvd., Sardaran Shahid Square., Bam City
City
Bam
Province
Kerman
Postal code
7667548912
Phone
+98 34 4431 9403
Email
mahmodi2020@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Fatemeh Mahmoudikohani
Position
Bam University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bam University of Medical Science., Shahid Rajaiee Blvd., Sardaran Shahid Square., Bam City
City
Bam
Province
Kerman
Postal code
7661713669
Phone
+98 34 4421 9248
Email
mahmodi2020@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Fatemeh Mahmoudikohani
Position
Bam University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bam University of Medical Science., Shahid Rajaiee Blvd., Sardaran Shahid Square., Bam City
City
Bam
Province
Kerman
Postal code
7661712669
Phone
+98 34 4421 9248
Email
mahmodi2020@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Fatemeh Mahmoudikohani
Position
Bam University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Bam University of Medical Science., Shahid Rajaiee Blvd., Sardaran Shahid Square., Bam City
City
Bam
Province
Kerman
Postal code
7661712669
Phone
+98 34 4421 9248
Email
mahmodi2020@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