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Evaluation of the effect of desensitization with eye movements and reprocessing on anxiety, hemodynamic parameters and duration of hospitalization in patients with COVID-19

Protocol summary

Study aim
Determining the effect of desensitization with eye movements and reprocessing on anxiety, hemodynamic indices and duration of hospitalization of patients with COVID 19 in Shahid Dr. Jalil Yasuj Medical Center in 2021
Design
Clinical trial with control group, simple randomized, on 90 patients
Settings and conduct
90 eligible patients with COVID-19 will be admitted to Shahid Jalil Hospital in Yasuj. Patients will be randomly divided into intervention and control groups.The amount of hemodynamic indicators will be recorded at the beginning of the study with a cardiopulmonary monitoring device. Before the intervention, both groups will be tested with the above questionnaires. Then, the desensitization group will be performed with eye movements and reprocessing according to the protocol in 3 sessions daily for 45-90 minutes in the patient's room in the company hospital. Both intervention and control groups will prescribe drugs prescribed by the doctor in accordance with standard protocols. They will receive Covid-19 treatment. However, no psychotherapy intervention will be performed on the control group during the research. The level of anxiety and hemodynamic indicators will be recorded at the end of each session.
Participants/Inclusion and exclusion criteria
Age between 18 to 65 years old; patients with COVID-19 who are PCR positive; having several clinical signs; does not have a specific disease
Intervention groups
The intervention group will perform desensitization with eye movements and reprocessing according to the protocol in 3 sessions daily for 45-90 minutes in the patient's room in the hospital. No psychotherapy intervention will be performed on the control group during the study.
Main outcome variables
Anxiety; blood pressure; respiratory rate; Oxygen saturation level; duration of hospitalization; eye movements and reprocessing

General information

Reason for update
Acronym
EMDR
IRCT registration information
IRCT registration number: IRCT20210823052263N1
Registration date: 2022-11-14, 1401/08/23
Registration timing: registered_while_recruiting

Last update: 2022-11-14, 1401/08/23
Update count: 0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Maliheh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3212 0318
Email address
maliheh.abbasi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of desensitization with eye movements and reprocessing on anxiety, hemodynamic parameters and duration of hospitalization in patients with COVID-19
Public title
The effectiveness of desensitization with eye movements and reprocessing on the recovery of patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years old Patients with COVID-19 who are PCR positive Has one or more clinical symptoms including fever less than or more than 38, sore throat with or without dry cough, chills, headache, loss of taste and smell, nausea and vomiting, anorexia, diarrhea, body aches, weakness and extreme tiredness Which has no other definite justification, and spo2 = 80-93, shortness of breath, feeling of pain or pressure in the chest No visual impairment and strabismus No cognitive impairment such as dementia or Alzheimer's Has no history of seizures Has no history of known mental disorder Not to be addicted to drugs Patients' anxiety level should be moderate to high according to Hamilton Anxiety Questionnaire
Exclusion criteria:
The patient did not cooperate with the therapist The patient has entered a severe phase due to pulmonary involvement and needs a niv mask or intubation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
For select the determined sample size of the study, a simple randomization method is used, in this way, a list of patients referred to Shahid Jalil Yasouj Hospital who meet the criteria for entering the study was prepared and with the help of a table of numbers The samples are randomly selected so that first a row or column is randomly selected and the direction of movement in the table is from left to right and then the numbers in each row or column equal to the previous one are assigned to one of the intervention or control groups and the number The pair equivalent to the intervention group and the odd number equivalent to the control group will be selected and in this way 45 samples will be selected for the intervention group and 45 samples will be selected for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, in such a way that the patients and researchers will be blinded. In this way, the patients and the researcher who measures the desired outcome do not know at first which people are the intervention group and which are the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari Boulevard, No. 105
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-06-01, 1400/03/11
Ethics committee reference number
IR.YUMS.REC.1400.043

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U08.9
ICD-10 code description
Personal history of COVID-19

Primary outcomes

1

Description
Anxiety score in Hamilton questionnaire
Timepoint
Before intervention and after intervention
Method of measurement
Hamilton anxiety questionnaire

2

Description
Hemodynamic status (blood pressure, respiration, oxygen saturation level) with patient monitoring
Timepoint
Before intervention and after intervention
Method of measurement
Monitoring device

3

Description
Duration of hospitalization
Timepoint
Before intervention and after intervention
Method of measurement
Date of admission and discharge included in the file

Secondary outcomes

1

Description
Sleep Quality Scale
Timepoint
At the beginning of the study and one and three months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Intervention groups

1

Description
The desensitization method with eye movements in the intervention group will be performed individually for each patient in three sessions and one session of 45 to 90 minutes each day. This is an eight-step method that emphasizes the physiological information processing system in the origin and treatment of mental health problems. The steps of this method in order and summary are history, explanation and preparation, investigation, target desensitization, creating positive cognition, processing the body. , creating positive recognition, ending the meeting and re-evaluating previously processed goals.
Category
N/A

2

Description
The control group will receive the drugs prescribed by the doctor for the treatment of COVID-19 according to the standard protocols. However, no psychotherapeutic intervention will be performed on this group during the research
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Jalil Hospital
Full name of responsible person
Saeed Javadan Sirat
Street address
Sports Street
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
8749375913
Phone
+98 74 3333 7001
Email
javdansirat@gmail.com
Web page address
http://shahidjalil.yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ahmad Oryan
Street address
Student Street
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3333 7251
Email
oryan1215@gmail.com
Web page address
https://yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Amin Haghgoo
Position
health education Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Street
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7594118438
Phone
+98 74 3333 7001
Email
amin.haghgoo65@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Haghgoo
Position
Educational Supervisor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Raza Street
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7594118438
Phone
+98 74 3333 7001
Email
amin.haghgoo65@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maliheh Abbasi
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Town
City
Gorgan
Province
Golestan
Postal code
4915773594
Phone
+98 17 3212 0318
Email
malihe.abbasi@gmail.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
Yes - There is 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
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
Part of the data in the excel or spss file
When the data will become available and for how long
6 months after the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Using data for analysis using statistical models
From where data/document is obtainable
Amin Haghoo Email: amin.haghgoo65@gmail.com
What processes are involved for a request to access data/document
Official request from the university or research institute
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