Determining the effect of mental imagery on anxiety and sleep quality in patients with Covid 19
Design
The clinical trial has a control and intervention group that is collected in two stages by referring to two groups of patients. Variables are examined before and after the intervention. 70 patients are purposefully divided into two groups based on a table of random numbers.
Settings and conduct
Data collection in this study is done by completing a questionnaire of demographic characteristics, Beck anxiety and sleep quality in Pittsburgh by the researcher in both groups, in the inpatient wards of patients in COVID-19.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients admitted to infectious wards due to Covid-19, without hearing, vision or speech impairment, non-use of drugs and alcohol and self-expression of participants in relation to: no depression, no use of antipsychotic drugs, Having a mobile phone.
Exclusion criteria: unwillingness to continue attending meetings, occurrence of stressful events such as: death of loved ones, accidents, deterioration of the patient and the need for hospitalization in the ICU
Intervention groups
Hospitalized patients with COVID-19
Main outcome variables
Helps to reduce anxiety, increase the quality of sleep in patients with COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180608040007N3
Registration date:2022-01-08, 1400/10/18
Registration timing:retrospective
Last update:2022-01-08, 1400/10/18
Update count:0
Registration date
2022-01-08, 1400/10/18
Registrant information
Name
Maryam Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
maryammohammadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
2020-10-22, 1399/08/01
Actual recruitment end date
2021-04-04, 1400/01/15
Trial completion date
empty
Scientific title
The effect of mental imagery on anxiety and sleep quality in patients with COVID-19
Public title
the effect of mental imagery on COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients admitted to infectious wards due to Covid 19
No hearing, vision or speech impairment
Do not use drugs and alcohol
Participants' self-declaration for: no depression, no use of antipsychotic drugs
Having a mobile phone
Exclusion criteria:
Occurrence of stressful events such as: death of loved ones, tragic events
Tendency to end treatment
Deterioration of the patient and the need for hospitalization in the ICU
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of intervention and control by census method with simple random assignment. Based on the time of filing in the admission unit, the patients who meet the inclusion criteria are selected from the infectious wards. Then, individual patients will be in the intervention group and paired patients will be in the control group, respectively. Sampling will continue until the total number of patients reaches 70 (35 patients in the intervention group and 35 patients in the control group).
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
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Central Administration, Bahonar Sq., Shahid Sadoughi University of Medical Sciences, Yazd Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.SSU.REC.1399.058
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Anxiety reduction based on Beck questionnaire
Timepoint
Measurement of anxiety, before intervention and one month after intervention
Method of measurement
Beck Anxiety Questionnaire
2
Description
Increase sleep quality
Timepoint
Measurement of sleep quality, before intervention and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 15 minutes are explained about mental imagery, and then in a 45-minute session, first muscle relaxation is performed and then mental imagery is performed under the guidance of the researcher. Perform the mental imagery steps and the content expressed by the patient's mobile phone and the participant is asked to listen to this recorded sound every day for three weeks and do mental imagery. In addition, perform tasks related to mental imagery identified by the researcher. Post-test in both groups will be completed by telephone by the researcher and research colleague by phone within 15 to 20 minutes four weeks after the intervention.
Category
Other
2
Description
Control group: .Control group: Due to the critical conditions and the possibility of rapid disease transmission, all safety conditions are observed to prevent the transmission of infection among patients and the researcher. In the control group, after completing the consent form, the pre-test is completed in a quiet and private environment, which is intended for all patients (intervention and control). The pre-test is answered by the patient in 15 to 20 minutes. Routine Covid-19 treatments continue in both groups according to the hospital infectious disease specialist. In the control group, only routine procedures are performed according to the doctor's instructions. The post-test is completed three weeks later by the researcher and research partner over a period of 15 to 20 minutes by telephone.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Yazd Hospital
Full name of responsible person
Maryam Mohammadi
Street address
Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
ba_zendegy@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
dr. masoud mirzaei
Street address
Central Administration Shahid Sadoughi University ofMedical Sciences, Bahonar Sq., Yazd Iran
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ba_zendegy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mohammadi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ba_zendegy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
MohammadBagher Khani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Sadoughi Yazd Hospital, Ebnesina Blvd.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
ba_darya@yahoo.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main consequences will be shared upon formal request.
When the data will become available and for how long
6 months after the article is published, it will be shared upon official request.
To whom data/document is available
Researchers working in academic and scientific institutions will be shared upon formal request.
Under which criteria data/document could be used
It will be shared upon formal request and use cases after review.
From where data/document is obtainable
ba_zendegy@yahoo.com
What processes are involved for a request to access data/document
After the official request, the determination of the uses will be provided after at least one month after the review and approval of the applicant.