Assessment of the effect of teleconsultation on the reduction of COVID-19 anxiety in patients with COVID-19 and the assessment of the satisfaction of patients referred to Jahrom General Medical Center with a teleconsultation service for the reduction of COVID-19 anxiety
Design
A single-blind, randomized clinical trial involving 188 patients. A randomization process using a random number table was used to randomize the rand function in Excel software.
Settings and conduct
This study was conducted to investigate the effects of educational interventions on anxiety in patients with COVID-19. The educational content delivered to the patients in the intervention group is delivered to the patients via the WhatsApp network in four sessions over four weeks. This study was conducted at the health center in the city of Jahrom. In this study, patients were not aware of their group's using questionnaire coding.
Participants/Inclusion and exclusion criteria
Inclusion criteria included positive PCR, age over 18 years, and interest in participating in the study: Inclusion criteria; Patient ill, underlying mental illness, inability to use relevant tools, and failure to complete at least 90 Percentages are questionnaires.
Intervention groups
The intervention group is the group that receives educational intervention, and the control group is the group that does not receive intervention.
Main outcome variables
Scores were obtained from the Beck Anxiety Questionnaire and scores were obtained from a questionnaire administered by researchers to assess patient satisfaction with the services provided.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211223053500N1
Registration date:2022-03-03, 1400/12/12
Registration timing:retrospective
Last update:2022-03-03, 1400/12/12
Update count:0
Registration date
2022-03-03, 1400/12/12
Registrant information
Name
marjan mosallanejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 6973
Email address
yasamanm455@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-28, 1400/10/07
Expected recruitment end date
2022-01-27, 1400/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of teleconsultation on Covid19 anxiety relief and satisfaction with these services in patients referred to general medical centers.
Public title
The effect of teleconsultation on the reduction of anxiety caused by COVID-19.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
PCR positive
Age over 18 years
Interest in participating in the study
Exclusion criteria:
Critically ill patients
Having an underlying mental illness
Inability to use relevant tools
Failure to complete at least 90% of the questionnaire
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method was used. Randomization units were used in this separate study. The tool used for randomization in this study was a random number table. The randomization process was done by someone who didn't know how to learn and how to do it. In this study, researchers and data collectors did not know how to group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, only patients were unaware of their group and the blinding was such that the researcher used a specific code in the header of each questionnaire to collect information without the patient knowing the nature of the code in the header of the questionnaire.
Placebo
Not used
Assignment
Other
Other design features
In this clinical trial, we will have two control and witness groups, in which patients are randomly divided into these two groups. A group of witnesses are patients who completed the Beck Anxiety Inventory twice but without intervention (who did not watch the training video). And the control group was patients who filled out the Beck anxiety questionnaire once before and after watching the educational video. Then compare the results of the two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hormozgan University of Medical Sciences
Street address
Chamran Boulevard, Hormozgan, Iran
City
Bandar Abbas
Province
Fars
Postal code
7916613885
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.HUMS.REC.1400.186
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Scores obtained from the Beck Depression Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Beck Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is delivered through educational clips, in which the clinical psychologist teaches the patient methods of anxiety management. This content has been scheduled in 4 different sessions. Educational videos are provided to patients via WhatsApp over 4 weeks, and patients can ask questions about the matter by phone or via the WhatsApp contact line with a psychologist. The first content is knowledge and introduction, goal description, concept and description of anxiety, its symptoms and consequences. The second part of the training is relaxation and stress reduction, the third part is training on how to deal with negative thoughts, and the fourth part is about familiarizing yourself with cognitive concepts, the role of of thought in generating anxiety and the relationship of thought to emotion and behavior.
Category
Treatment - Other
2
Description
Control group: Patients in the control group did not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom Comprehensive Health Center
Full name of responsible person
kavous solhjo
Street address
Jihad Square - Clinic No. 4
City
Jahrom
Province
Fars
Postal code
7916613885
Phone
+98 71 5423 0014
Email
info@jums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Timur Amlahi
Street address
south ressalat
City
bandar abbass
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3368 5230
Email
pshora2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Marjan Mosallanejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Asadabadi Alley, Dadgsotaro St., Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5444 6973
Fax
Email
yasamanm455@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Marjan Mosallanejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Asadabadi Alley, Dadgsotaro St., Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5444 6973
Fax
Email
yasamanm455@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Marjan Mosallanejad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Asadabadi Alley, Dadgsotaro St., Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5444 6973
Fax
Email
yasamanm455@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