The effectiveness of improving body awareness skills on anxiety, depression, and quality of life of patients after heart surgery in Bu Ali Hospital in Qazvin
Evaluation of the effectiveness of improving body awareness skills on anxiety, depression, and quality of life of patients after heart surgery
Design
Clinical trial with control group with parallel, randomized, phase 3 groups on 50 patients. A random number table was used for randomization.
Settings and conduct
This intervention takes place in the city of Qazvin. Patients who have undergone heart surgery are randomly divided into two nodes. Patients will be trained in bodybuilding exercises. These trainings are given to patients under the supervision of a psychiatrist and according to the training protocols of the World Health Organization. Before and one week after the interventions, the rate of depression and anxiety as well as the quality of life of patients are measured by special questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have undergone heart surgery, interest in participating in research and informed consent, full consciousness and having the necessary ability to participate in the study, age 18 to 65 years. Exclusion criteria: History of mental disorder based on DSM-5 diagnostic criteria, except depression, drug use and stimulants, mourning of loved ones during the last quarter.
Intervention groups
Intervention group: Patients in this group will be trained in bodybuilding exercises for six hours a week for two weeks. These trainings are given to patients under the supervision of a psychiatrist and according to the training protocols of the World Health Organization. Before and one week after the interventions, the rate of depression and anxiety as well as the quality of life of patients are measured by special questionnaires.
Main outcome variables
Anxiety score, Depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190404043159N2
Registration date:2020-10-02, 1399/07/11
Registration timing:prospective
Last update:2020-10-02, 1399/07/11
Update count:0
Registration date
2020-10-02, 1399/07/11
Registrant information
Name
Mohammad Reza Sharbafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
sharbafchi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-05, 1399/07/14
Expected recruitment end date
2020-11-04, 1399/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of improving body awareness skills on anxiety, depression, and quality of life of patients after heart surgery in Bu Ali Hospital in Qazvin
Public title
Improving body awareness skills and anxiety, depression, and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have had heart surgery
Interest in participating in research and informed consent
Full consciousness and having the necessary ability to participate in the study
Age 18 to 65 years
Exclusion criteria:
History of mental disorder based on DSM-5 diagnostic criteria except depression.
Drugs or stimulants abuse
Mourning of loved ones during the last three months.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
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 Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.MUI.MED.REC.1398.211
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features
3
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score
Timepoint
Before and one week after interventions
Method of measurement
By The Depression, Anxiety, and Stress Scale – 21 (DASS-21) questionnaire
2
Description
Depression score
Timepoint
Before and one week after interventions
Method of measurement
By The Depression, Anxiety, and Stress Scale – 21 (DASS-21) questionnaire
3
Description
Quality of life score
Timepoint
Before and one week after interventions
Method of measurement
MacNew Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will be trained in bodybuilding exercises for six hours a week for two weeks. These trainings are given to patients under the supervision of a psychiatrist and according to the training protocols of the World Health Organization. Before and one week after the interventions, the rate of depression and anxiety as well as the quality of life of patients are measured by special questionnaires.
Category
Treatment - Other
2
Description
Control group: For patients in this group, the rate of depression and anxiety as well as the quality of life of patients are measured by special questionnaires. Patients will not receive training. 1 week after the study, the rate of depression and anxiety as well as the quality of life of patients are measured twice by special questionnaires.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Mohammad Reza Sharbafchi
Street address
No. 22, Roshd St., Imam Khomeini Blvd., Qazvin
City
Qazvin
Province
Qazvin
Postal code
6774672561
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Fax
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Reza Sharbafchi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
sharbafchi@med.mui.ac.ir
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
Yes - There is 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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.