Determining the effect of virtual training of relaxation technique (Jacobsen and Benson) on anxiety of home quarantine patients with Covid 19.
Design
The present study will be performed as a randomized clinical trial with a control group, with two parallel groups with the participation of 60 patients.
Settings and conduct
The present study will be conducted as a randomized clinical trial with the participation of 60 patients with Covid 19. After dividing the research units into control and test groups, questionnaires will be completed before the intervention. The control group receives routine quarantine care at home. In the experimental group, in addition to routine care, the intervention will be in the form of sending instructional videos on how to perform Benson and Jacobson voting techniques for four weeks. Will be completed virtually in the test and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a desire to participate in the study, Having an anxiety score higher than 20 based on the questionnaire
Exclusion criteria: Reluctance to continue participating in the study, Use of stimulants and psychotropic drugs during the study.
Intervention groups
Intervention group: In the intervention group, in addition to routine care, the intervention will be performed in the following way: Benson and Jacobson relaxation pamphlets and educational videos will be sent to patients with Covid-19 according to the schedule. Each training message is sent to individuals twice a week for 4 weeks.
Control group: The control group will receive routine quarantine care at home.
Main outcome variables
Patients' anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N34
Registration date:2021-01-16, 1399/10/27
Registration timing:prospective
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual relaxation technique training (Jacobson and Benson) on anxiety in home quarantine patients with Covid -19
Public title
effect of virtual relaxation technique training (Jacobson and Benson) on anxiety in patients with Covid -19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a desire to participate in the study
Have access to a smartphone, the Internet and how to use WhatsApp software.
Having an anxiety score higher than 20 based on the questionnaire
Exclusion criteria:
Reluctance to continue participating in the study
Use of stimulants and psychotropic drugs during the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into two groups intervention(A) and control (B).
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.UMSHA.REC.1399.563
Health conditions studied
1
Description of health condition studied
Covid-19 disease
ICD-10 code
U07. 1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Anxiety
Timepoint
Before and two weeks after the educational intervention
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, in addition to routine care, the intervention will be performed as follows: Benson and Jacobson relaxation pamphlets and training videos will be sent to patients with Covid-19 according to the schedule. Each training message is sent to individuals twice a week for 4 weeks.
Category
Rehabilitation
2
Description
Control group: The control group will receive routine quarantine care at home and no special intervention will be performed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Besheshti hospital
Full name of responsible person
Shadi Dalvand
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shadi Dalvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shadidalvand407@gmail.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