Comparing of the Effect of Supportive Educative Program with Routine educative program on Stress, Anxiety, Depression and Satisfaction of Patients With COVID-19 Admitted to COVID units
Effect of Supportive Educative Program on Stress, Anxiety, Depression and Satisfaction of Patients with COVID-19
Design
Clinical trial with control group with parallel groups without blinding with random assignment of samples to groups that will be performed on 60 hospitalized patients with definit diagnosis of COVID-19, Random allocation is done using a random sequence generated by the randomization site (at www.randomization.com).
Settings and conduct
This study will be performed on 60 patients with COVID-19 referring to the emergency departments of COVID hospitals in Najaf. No blinding will be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Positive COVID PCR test; with p/f ratio < 200; complete awareness.
Non inclusion Criteria: history of mental disorder; previous history of COVID-19; history of using psychotropic drugs and Narcotics
Intervention groups
Intervention group: expressing empathy with patient and focusing on his concerns at the beginning of the patient's awareness of the diagnosis of COVID-19, Provide the patient with a comprehensive pamphlet based on the educational needs of patients with COVID 19 in need of hospitalization, identifying the patient's trusted companion, and giving him or her a contact number to make telephone and video calls. Also the researcher will answer the concerns and questions that have made for the patient during the hospitalization period.
Control group: They receive the usual care and training of Najaf hospitals
Main outcome variables
Depression, anxiety and stress; Patient satisfaction with the quality of care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140625018231N1
Registration date:2021-11-05, 1400/08/14
Registration timing:registered_while_recruiting
Last update:2021-11-05, 1400/08/14
Update count:0
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
hajiabadif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the Effect of Supportive Educative Program with Routine educative program on Stress, Anxiety, Depression and Satisfaction of Patients With COVID-19 Admitted to COVID units
Public title
The Effect of Supportive Educative Program in COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Positive COVID-19 PCR test and definit diagnosis of COVID-19
COVID-19 Patient with P/F ratio <200
Definite need to be hospitalized in COVID-19 ward
Full awareness and awareness to time and place
Exclusion criteria:
Having a history of mental disorders
Employment in the treatment team
Having a previous history of COVID-19
Having a history of using psychotropic drugs and narcotics
Age
From 18 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
Random allocation is done using random sequences generated by the randomization site.It is done by randomization site (with the site address www.randomization.com). To prepare a random sequence using this site, considering that the total sample size is 60 people in two groups of control and intervention, in this site for 2 groups of 30, the number of blocks of size 4 is given to the site and the random sequence will be obtained. To conceal the assignment, this sequence is placed in sealed envelope until each research unit enters the study.
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 Mashhad University of Medical Sciences
Street address
Nursing and Midwifery Collage, Ebne Sina Ave., Doctora intersection, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.028
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
Level of depression
Timepoint
immediately after hospitalization, at the end of the first day of hospitalization and 5 days after hospitalization in both control and intervention groups
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS)
2
Description
Level of Anxity
Timepoint
immediately after hospitalization, at the end of the first day of hospitalization and 5 days after hospitalization in both control and intervention groups
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS)
3
Description
Level of Stress
Timepoint
immediately after hospitalization, at the end of the first day of hospitalization and 5 days after hospitalization in both control and intervention groups
Method of measurement
Depression, Anxiety and Stress Questionnaire (DASS)
4
Description
Patient satisfaction with the quality of care
Timepoint
For both intervention and control groups 5 days after hospitalization
Method of measurement
Patient Satisfaction Questionnaire (PSI) to measure patient satisfaction with the quality of care
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: expressing empathy with patient and focusing on his concerns at the beginning of the patient's awareness of the diagnosis of COVID-19, Provide the patient with a comprehensive pamphlet based on the educational needs of patients with COVID_19 in need of hospitalization, identifying the patient's trusted companion, and giving him or her a contact number to make telephone and video calls. Also the researcher will answer the concerns and questions that have arisen for the patient during the hospitalization period and provide the required training according to the patient's needs.
Category
Behavior
2
Description
Control group:No Educative and suppurtive programs are provided or performed for patients, and nurses and the treatment team spend their time performing treatment measures such as medication, oxygen therapy, and other procedures.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency wards, ICU and COVID wards of Alhakim hospitals for patients with COVID-19 in Najaf