Determining the effect of scheduled visit on family mental health components of patients undergoing open heart surgery
Design
Eligible samples are assigned to two groups based on the random assignment method of permutation blocks. These permutation blocks are constructed using a random number table. Then, different consecutive weeks are assigned to the test and control groups based on this random allocation method.
The sample size based on PASS software version 15 about 33 people in each group were considered.
Settings and conduct
First, after receiving the code of ethics and the letter of introduction, the research method is explained to the patient and the family. In order to observe the etiquette for the family members of the visiting candidate (intervention), a training class of 10-15 minutes is formed only on the first day. It takes place at 3 pm (the first two days of the meeting) and 11 am (the third day of the meeting) in the presence of the researcher at post-icu. In both groups, the questionnaires are filled in on the first and last day.
Participants/Inclusion and exclusion criteria
1. Having a relative relationship with the patient
2. Do not suffer from major mental disorders
3. No history of using drugs, alcohol and psychotropic drugs
4. Be literate
5. No family problems
Intervention groups
In the intervention group, the appointment starts from the time the patient enters the PACU from the ICU for 30 minutes 3 times a week (3 consecutive days) at 3 pm (the first two days of the appointment) and 11 am (the third day of the appointment) in the presence of the researcher. However, the control group visits their patients according to the ward policy.
Main outcome variables
Reduce anxiety
Reduce depression
Reducing stress
Increase perceived social support
Increase satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220216054043N1
Registration date:2022-02-22, 1400/12/03
Registration timing:retrospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Hadis Assadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 7077
Email address
h.assadollahi72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-02, 1399/12/12
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
2021-03-02, 1399/12/12
Actual recruitment end date
2021-09-21, 1400/06/30
Trial completion date
2021-09-21, 1400/06/30
Scientific title
The effect of scheduled Visitation on the components of mental health of the families whose patients have undergone open heart surgery
Public title
The effect of scheduled Visitation on the components of mental health of the families
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having a relative relationship with the patient
2. Do not suffer from major mental disorders (depression, schizophrenia, anxiety) according to self-expression
3. No history of using drugs, alcohol and psychotropic drugs
4. Be literate
5. No family problems during the last 6 months (death of loved ones, divorce)
Exclusion criteria:
1. Death of the patient
2. Withdrawal from attending the study
3. Absence from all sessions until the end of the intervention
4. Non-compliance with the research protocol (especially in the control group)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples are assigned to two groups based on the random assignment method of permutation blocks. These permutation blocks are constructed using a random number table. Then, different consecutive weeks are assigned to the test and control groups based on this random allocation method. Thus, the second week may be randomly assigned to the control group and the third week to the control group, the fourth week to the experimental group and so on.
The sampling method of the patient's family will be unlikely to be sequential. That is, we continue sampling in the order of hospitalization time in POST-ICU and according to the entry and exit criteria to complete the required sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
No.18,pardeesan7,
City
Khorramabad
Province
Lorestan
Postal code
6816845933
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.LUMS.REC.1399.335
Health conditions studied
1
Description of health condition studied
Scheduled Visitation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score, Depression score, Stress score, Satisfaction score, Perceived social support score
Timepoint
On the first day before the intervention On the third day after the intervention
Method of measurement
. Depression Anxiety Stress Scale 21, Family Satisfaction in the Intensive Care Unit questionnaire ,. Multidimensional Scale of Perceived Social Support
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The appointment starts from the time the patient enters the PACU from the ICU for 30 minutes 3 times a week (3 consecutive days) at 3 pm (the first two days of the appointment) and 11 am (the third day of the appointment) in the presence of the researcher.
Category
Other
2
Description
Control group: According to the routine section
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Dr. Nasrin Galedar
Street address
Khorramabad, East Goldasht, next to Social Security Hospital, School of Paramedical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 916 361 1417
Fax
+98 66 3342 0030
Email
h.assadollahi72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Nasrin galedar
Street address
Khorramabad, East Goldasht, next to Social Security Hospital, School of Paramedical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 916 361 1417
Fax
+98 66 3342 0030
Email
galehdar_n@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Nasrin galedar
Position
Educational Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad, East Goldasht, next to Social Security Hospital, School of Paramedical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3340 9971
Fax
+98 66 3342 0030
Email
galehdar_n@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Nasrin galedar
Position
Educational Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad, East Goldasht, next to Social Security Hospital, School of Paramedical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3340 9971
Fax
+98 66 3342 0030
Email
galehdar_n@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Nasrin galedar
Position
Educational Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khorramabad, East Goldasht, next to Social Security Hospital, School of Paramedical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6819789741
Phone
+98 66 3340 9971
Fax
+98 66 3342 0030
Email
galehdar_n@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
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
Only part of the data can be published. Personal data remains confidential. Data are among the results of the study and statistical analysis before publication.
When the data will become available and for how long
After completing the research
To whom data/document is available
Employed researchers or academic institutions
Under which criteria data/document could be used
To be used for other research work
From where data/document is obtainable
Hadis Asadollahi executor of plan
Dr. Nasrin Galedar responsible person
What processes are involved for a request to access data/document