The Comparison effect of Group Discussion and Video-Learning on Stress, anxiety,depression and self-efficacy in patients undergoing Pacemaker and Implantable- Cardioverter Defibrillator
Comparison of the effect of training by video and group discussion on the stress, anxiety and self-efficacy of pacemaker patients and cardiac implantation defibrillator referred to Shahid Beheshti Hospital in Kashan 2017
Training for Patients with Pacemaker and Implantable Cardioverter Defibrillator, Kashan University of Medical Sciences Hospital, as group and video training sessions
Participants/Inclusion and exclusion criteria
Patients with pacemakers and implantable cardioverter defibrillator
The Comparison effect of Group Discussion and Video-Learning on Stress, anxiety,depression and self-efficacy in patients undergoing Pacemaker and Implantable- Cardioverter Defibrillator
Public title
The effect of training on stress, anxiety,depression and self-efficacy in patients with pacemakers and cardiopulmonary defibrillator
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are first implanted with pacemakers or cardiac defibrillators.
They tended to participate in the study.
Were in the age group of 18-75 years old.
No psychiatric illness.
The patient himself or his relatives were not members of the health team.
Exclusion criteria:
The patient died during the study.
During the study, you should not cooperate with the researcher
An unfortunate event that adds to anxiety and reduces self-efficacy.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
After the device was fitted, the informed consent form was given to qualified patients willing to participate in the study, and after completing the pre-test written permission and ensuring the confidentiality of the information, a demographic information questionnaire for the patients was completed.After completing initial information and rejection of psychiatric diseases, if the patient was at the age group and the patient or first-degree relatives were not part of the medical staff, they were divided into three groups based on the age group and date of the device, and according to the necessity Group discussion sessions were held for the video, the beginning of training with the group was discussed.
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8741135911
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.24
Health conditions studied
1
Description of health condition studied
Patients with pacemakers or cardiac implantation defibrillators
ICD-10 code
Z95.0
ICD-10 code description
Presence of cardiac pacemaker
Primary outcomes
1
Description
Stress score in the questionnaire DASS21
Timepoint
At the beginning of the study (before the training) and three weeks after the training
Method of measurement
Stress questionnaire DASS21
2
Description
Anxiety score in the questionnaire DASS21
Timepoint
At the beginning of the study (before the training) and three weeks after the training
Method of measurement
Anxiety questionnaire DASS21
3
Description
Depression score in the questionnaire DASS21
Timepoint
At the beginning of the study (before the training) and three weeks after the training
Method of measurement
Depression questionnaire DASS21
4
Description
Self-efficacy scores in self-efficacy questionnaire for patients with pacemakers
Timepoint
At the beginning of the study (before the training) and three weeks after the training
Method of measurement
Self-efficacy questionnaire for patients with pacemakers
5
Description
Self-efficacy score in patients self-efficacy questionnaire has Cardiac implantable cardioverter defibrillator
Timepoint
At the beginning of the study (before the training) and three weeks after the training
Method of measurement
Self-efficacy questionnaire for patients with implantable cardioverter defibrillator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Learning by group discussion method : After calling patients and forming groups of 10-6, structured training was started during a 2-hour session at the conference hall of Shahid Beheshti Hospital with the participation of researchers after the completion of the initial questionnaires.
Category
Behavior
2
Description
Intervention group 2: Video tutorial: After filming the content provided by the researchers in the group discussion group and reviewing and editing, a compact disc prepared from each session is reviewed by three qualified individuals (an educational expert and two cardiologists) in the minimum possible time (7-10 days). And confirmed and presented to the video tutoring group in person after completion of the initial questionnaires. The approximate duration of the video was about an hour and fifteen minutes.
Category
Behavior
3
Description
Control group: Routine tutorial: This group did not receive any educational intervention except for a manual and explanations provided by the department to all patients (even two educational groups).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Medical Sciences Hospital
Full name of responsible person
Sareh Sokout Arani
Street address
Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8741135911
Phone
+98 31 5554 0021
Email
s.sokoutmedical89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Allahyar Golabchi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Gotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8741135911
Phone
+98 31 5554 0021
Email
s.sokoutmedical89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Allahyar Golabchi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ghotbe Ravandi Blvd.
City
Kashsn
Province
Isfehan
Postal code
8741135911
Phone
+98 31 5554 0021
Email
s.sokoutmedical89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Allahyar Golabchi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8741135911
Phone
+98 31 5554 0021
Email
s.sokoutmedical89@gmail.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