Protocol summary

Study aim
To assess the efficacy of teaching and training techniques to improve the resilience of nurses in the COVID-19 pandemic in Mashhad (including online sessions of the Anticipate-Plan-Deter method and Psychological First Aid training sessions).
Design
A non-randomized clinical trial, without a control group, not blinded on 80 nurses, with before-and-after intervention evaluation
Settings and conduct
This study will be performed in the Ibne-Sina psychiatric hospital under the supervision of the Psychiatric Research and Behavioral Sciences Center of Ibn-Sina psychiatric hospital in Mashhad. Recruitment will be done through advertising online, and the invitation and information about the time and the date will be sent to the university emails of the nurses. This study will not have a control group. And will not be blinded. Training sessions will be held online for three consecutive days, for 75 minutes each day. In each session, a psychiatric resident, under the supervision of a psychiatry faculty member, will present the material, while showing the relevant slides. Evaluation will be done through questionnaires before-and-after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nurses involved in caring for the patients with COVID-19 Informed consent to participate in the study Exclusion criteria: Announcing the presence of the major psychiatric problems in the demographic questionnaire ( major depression, bipolar disorder, schizophrenia)
Intervention groups
Resilience skills programs including the Anticipate-Plan-Deter program and the Psychological First Aid will be taught in three virtual training sessions for the nurses.
Main outcome variables
Resilience, Corona virus-related anxiety, emotional processing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211105052971N1
Registration date: 2022-02-04, 1400/11/15
Registration timing: prospective

Last update: 2022-02-04, 1400/11/15
Update count: 0
Registration date
2022-02-04, 1400/11/15
Registrant information
Name
Nasim Kamalahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 7546
Email address
nasim.k.ahmadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To assess the efficacy of teaching and training techniques to improve the resilience of nurses in the COVID-19 pandemic
Public title
Effect of training sessions on the nurses' resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses involved in caring for the patients with COVID-19 Informed consent to participate in the study
Exclusion criteria:
Announcement of the presence of the major psychiatric problems in the demographic questionnaire ( major depression, bipolar disorder, schizophrenia )
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, three sessions of resilience skills training will conduct as virtual and online lectures.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine- Mashhad University of Medical Sciences
Street address
Ethics Committee of School of Medicine, Mashhad University of Medical Sciences, Ghorashi Building, next to Hoveyzeh Cinema, Daneshgah St., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.435

Health conditions studied

1

Description of health condition studied
Burn out, COVID-19, Anxiety, Resilience, Psychological, Health Personnel, Education, emotional intelligence
ICD-10 code
Z73.0
ICD-10 code description
Burn out, State of vital exhaustion,

Primary outcomes

1

Description
Resilience score in Connor-Davidson Resilience Scale (CD-RISC)
Timepoint
Resilience score in Connor-Davidson Resilience Scale (CD-RISC), at the beginning of the study (before the start of the first training session), and then one week after the third training session (i.e. one month after the first questionnaire)
Method of measurement
Online assessment of Connor-Davidson Resilience Scale (CD-RISC)

Secondary outcomes

1

Description
Score of Coronavirus related anxiety
Timepoint
At the beginning of the study (before the start of the first training session) and then one week after the third training session (i.e. one month after the first questionnaire)
Method of measurement
Online assessment of Coronavirus Anxiety Scale

2

Description
The score of Emotional Processing Scale
Timepoint
At the beginning of the study (before the start of the first training session) and then one week after the third training session (i.e. one month after the first questionnaire)
Method of measurement
Online assessment of the Baker Emotional Processing Scale

Intervention groups

1

Description
Intervention group: Three training sessions will be held online for three consecutive weeks, each day for 75 minutes. In each session, a psychiatric assistant, under the supervision of the psychiatry faculty member, will present the material, while showing the relevant slides. During the sessions, exercises related to the content of each session will be performed by the participants, and a picture of it will be sent virtually to the course instructor. Content of the sessions: Session 1: The psychological effects of the Corona crisis on the healthcare workers and the concept and importance of resilience and burnout will be explained. Then one of the methods to promote resilience will be introduced Anticipate-Plan-Deter method. Session 2: The Anticipate-Plan-Deter method will be taught. Session 3: The Psychological First Aid will be taught thoroughly in-depth.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebn'e Sina psychiatric hospital, Psychiatry and Behavioral Sciences Research Center
Full name of responsible person
Nasim Kamalahmadi
Street address
Ebn'e Sina psychiatric hospital, Horr Ameli Blvd, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
ISH.IT@MUMS.AC.IR
Web page address
https://sina.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Knowledge and Health City , In the end of Shahid Fakouri Blvd (In front of Fakouri 94) , Mashhad , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3879 5031
Fax
+98 51 3871 3638
Email
Info.en@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nasim Kamalahmadi
Position
Psychiatrics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebn'e Sina psychiatric hospital, Horr Ameli Blvd, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
nasim.k.ahmadi@gamil.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasim Kamalahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebn'e Sina psychiatric hospital, Horr Ameli Blvd, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
nasim.k.ahmadi@gamil.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasim Kamalahmadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebn'e Sina psychiatric hospital, Horr Ameli Blvd, Mashhad, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2701
Email
nasim.k.ahmadi@gamil.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
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