Protocol summary
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Study aim
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Comparison of interactive psycho-educational interventions via social networks with placebo on anxiety and self-efficacy of patients infected with COVID-19 and lived in home quarantine
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Design
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A clinical trial with control group, parallel group randomized trial and single blinded
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Settings and conduct
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The setting is Shiraz city. In this study, a person who collects the outcomes of the study, as well as a statistician and health care provider, will be blind until the end of the study and completion of the data analysis and reporting.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria of this study are aging ≥ 18 years, having diagnosis of COVID-19, being able to use cell phone and having access to Internet, being at home quarantine at least 48 hours, having need to be in home quarantine at least one week. Patients who are admitted in hospital, are died, have severe symptoms that not being able to speak, perform exercise or complete the questionnaires, have previous experience of home quarantine and have psychological diseases such as psychosis and dementia are excluded.
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Intervention groups
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The patients in the intervention group are enrolled in a WhatsApp group. They would receive numerous videos, audio files, and educational texts regarding mental health, coping strategies, positive thinking, hope, spiritual well-being, and some enjoyable activities such as relaxation music. Other psychological interventions are included encouraging the patients to apply trained psychological techniques, and sharing good memories of their lives, gratitude and thanking God, and expressing their positive abilities in a variety of areas in the group. Every day, a researcher is contacted to the subjects and approved they would continued and followed as order.
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Main outcome variables
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self-efficacy and anxiety
General information
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Reason for update
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Since the approval of this clinical trial in IRCT on 2020-05-01, the recruitment start date changed to 2020-05-02.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130616013690N7
Registration date:
2020-05-01, 1399/02/12
Registration timing:
prospective
Last update:
2020-05-08, 1399/02/19
Update count:
1
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Registration date
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2020-05-01, 1399/02/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-02, 1399/02/13
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Expected recruitment end date
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2020-06-19, 1399/03/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of interactive psycho-educational interventions via social networks with placebo on anxiety and self-efficacy of patients infected with COVID-19 and lived in home quarantine
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Public title
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Effect of interactive psycho-educational interventions on patients infected with COVID-19
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
aging ≥ 18 years
having diagnosis of COVID-19
being able to use cell phone and having access to Internet
being at home quarantine at least 48 hours
having need to be in home quarantine at least one week
Exclusion criteria:
who is admitted in hospital
is died
have severe symptoms that not being able to speak, perform exercise or complete the questionnaires
has previous experience of home quarantine
has psychological diseases such as psychosis and dementia
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first the cellphone numbers of the patients who has inclusion criteria are obtained. Then, 50 participants randomly are selected using randomization software. Then, in order to allocation the subjects in to the intervention or control group, a randomization software is used.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The person who is collected the outcomes by a Link and the statistician are blind in to the intervention and control groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-17, 1398/12/27
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Ethics committee reference number
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IR.SUMS.REC.1399.012
Health conditions studied
1
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Description of health condition studied
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Coronavirus disease (COVID-19)
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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self-efficacy
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Timepoint
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Before, one week and two weeks after the intervention
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Method of measurement
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People to Promote Health (SUPPH) questionnaire
2
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Description
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Anxiety
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Timepoint
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Before, one week and two weeks after the intervention
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Method of measurement
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State-Trait Anxiety Inventory
Intervention groups
1
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Description
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"Intervention group:" The patients in the intervention group are enrolled in a WhatsApp group. They will receive numerous videos, audio files, and educational texts regarding mental health, coping strategies, positive thinking, hope, spiritual well-being, and some enjoyable activities such as relaxation music. Other psychological interventions are included encouraging the patients to apply trained psychological techniques, sharing good memories of their lives, gratitude and thanking God, and expressing their positive abilities in a variety of areas in the group.The intervention is performed for eleven days from morning to 9 pm, and the files are entered in the WhatsApp group every two hours during the day.
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Category
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Lifestyle
2
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Description
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Control group: This group would receive the routine care and would not receive any of the interventions of the intervention group.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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primary outcome measure
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When the data will become available and for how long
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starting 6 months after publication
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To whom data/document is available
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This will be available for people working in academic institutions
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Under which criteria data/document could be used
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The results of this study will be used for others.
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From where data/document is obtainable
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Contact to Maryam Shaygan email address, (shayganm@sums.ac.ir).
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What processes are involved for a request to access data/document
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Contact to Maryam Shaygan email address, (shayganm@sums.ac.ir).
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Comments
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