Determining the effect of eye movements desensitization and reprocessing in real and virtual methods and comparing them on fear of COVID 19 in nurses
Design
Controlled clinical trial, with three parallel groups, phase 2 on 159 people, without blinding, randomization of a balanced blocking method with the help of web-based sequence generation software
Settings and conduct
Hospitals of Qazvin
Participants/Inclusion and exclusion criteria
Have a bachelor's degree in nursing or higher; Activity in the corona for at least 6 months; Complete satisfaction for the company; Do not receive other educational interventions at the same time as the plan; Having an account on one of the social networks with video communication
Intervention groups
Three groups will be present in this study. The first group is the real group, in which first the level of fear of Quaid is measured and then EMDR (eye movements desensitization and reprocessing) will be performed for them to reach the same number of fear of Quaid in at least two consecutive sessions. And in the second group, which are virtual, the same operation will be done virtually, and the control group will be without any intervention.
Main outcome variables
Effect of EMDR (eye movements desensitization and reprocessing) on fear of covid 19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220222054101N1
Registration date:2022-06-18, 1401/03/28
Registration timing:registered_while_recruiting
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
Seyyed Mahdi Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3525 0056
Email address
smahdimousavi7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-18, 1401/03/28
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the Effect of Desensitization with Eye movements and Reprocessing on the fear of Covid 19 in a virtual and real way on nurses
Public title
Comparative study of the Effect of Desensitization with Eye movements and Reprocessing on the fear of Covid 19 in a virtual and real way on nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a bachelor's degree in nursing or higher
Activity in the covid19 ward for at least 6 months
Complete satisfaction to enter into partnership
Do not take other educational interventions at the same time as the plan
Having an account on one of the social networks with video communication
Exclusion criteria:
Intolerance and resilience of the person during desensitization with eye movements and reprocessing,
Having a DSM-5 based mental illness leads to hospitalization
visit a psychiatrist and take medication
vision impairment by self report
Taking psychotropic drugs
Having a history of PTSD, self-purifying
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible applicants will be able to register with the willingness to participate in the study. Then, with the method of 6 random blocking, random assignment of participants in three groups with a ratio of 1: 1: 1 will be done. Random allocation sequence generation software will be used to determine the allocation sequence by 6-block method. To hide the allocation sequence, the papers identifying the group of individuals are placed inside the envelopes in the opaque package, respectively, and encoded in the same way. In this case, for the person who receives the intervention code 1, a questionnaire with the same code is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Qazvin University of Medical Sciences
Street address
Pardis of university,staff of Qazvin university of medical science,Complex of offices,Shahid Bahonar blvd, Navab shomal st,Qazvin town
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2022-05-09, 1401/02/19
Ethics committee reference number
IR.QUMS.REC.1401.026
Health conditions studied
1
Description of health condition studied
Fear of covid 19
ICD-10 code
Z71.1
ICD-10 code description
Person with feared health complaint in whom no diagnosis is made
Primary outcomes
1
Description
Fear of covid 19
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
The Fear of COVID-19 Scale FCV-19S
Secondary outcomes
1
Description
Anxiety and depression after confronting covid 19
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
Hospital anxiety depression scale HADS
2
Description
Quality of working life after confronting covid 19
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
Quality of working life (QWL)
Intervention groups
1
Description
Intervention group: real: Content of sessions in at least 2 sessions of 90 to 45 minutes twice a week and by performing Eye movement desensitization and reprocessing (EMDR)in hospitals affiliated to Qazvin University of Medical Sciences in a suitable and quiet atmosphere to focus on the intervention of nurses, after initial explanations about EMDR and How to do it and about its advantages will be done in the first session. During the intervention, the control group will work as usual. A psychiatric nursing graduate student who has completed and mastered the EMDR course will be the presenter and performer of the technique. Intervention sessions continue as long as the Mental Disorder Scale Subjective Units of Disturbance (SUD) is a fixed number in two sessions.
Category
Treatment - Other
2
Description
Intervention group: virtual: After explaining the therapist about Eye Movement Desensitization and Reprocessing (EMDR) and how to do it and how to use the video, as well as about the benefits and functionality of the EMDR video content prepared by the master student of psychiatry, the player and the therapist on a handheld computer Performs the necessary checks in the presence of the client and makes sure that the client does it correctly. After using the video, they will be asked to complete the Covid Fear Questionnaire. Intervention sessions will continue as long as the Subjective Units of Disturbance (SUD) is a fixed number in two sessions.
Category
Treatment - Other
3
Description
Control group: just they fill the scales before T after T and 3 month later
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Sina Teaching Center
Full name of responsible person
Dr. Mohammad Haji Abadi
Street address
Boalisina street
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 2930
Email
hosboali@qums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rajaie hospital
Full name of responsible person
Maryam Rajabi
Street address
Padegan street
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir
3
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Dr Seyyed Hamidreza Ghafeleh Bashi
Street address
Elahiyeh
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3379 0620
Email
velayat@qums.ac.ir
4
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Abotaleb simiyari
Street address
Kosar street
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3323 6378
Email
itkosar@qums.ac.ir
5
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Dr Mahdi Alizadeh
Street address
Shahid Beheshti
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 4807
Email
hosghods@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abdollah dideh ban
Street address
University Campus, Office Complex, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, North Navab St, Qazvin town
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
internationalaffairs@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research of Qazvin 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 36, 8th Golafshan Ave, Sayyad street , Abhar town
City
Abhar
Province
Zanjan
Postal code
4566155179
Phone
+98 24 3525 0056
Email
SMAHDIMOUSAVI7@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammadreza Sheikhi
Position
PhD Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University Campus, Office Complex, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, North Navab St, Qazvin town
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 912 282 1450
Email
mmsheikhi1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mahdi Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 36, 8th Golafshan Ave, Sayyad street , Abhar town
City
Abhar
Province
Zanjan
Postal code
4561655179
Phone
+98 24 3525 0056
Email
smahdimousavi7@gmail.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
Comparative study of the Effect of Desensitization with Eye movements and Reprocessing on the fear of Covid 19 in a virtual and real way on nurses working in Qazvin hospitals: Randomized Clinical Trial
When the data will become available and for how long
6 month after Publish of results
To whom data/document is available
Nursing students
Under which criteria data/document could be used
Direct permission
From where data/document is obtainable
smahdimousavi7@gmail.com send an email
What processes are involved for a request to access data/document