Protocol summary

Study aim
The effect of “Narrative writing” on psychological health and hope in patient with covid-19
Design
A controlled clinical trial, with parallel groups, without blinding, randomized, phase 2 on 42 patients with coronary artery disease who were randomly assigned to one of the narration groups using the website www.random.org and The control group (without intervention) is assigned.
Settings and conduct
The procedure is as follows: In the intervention group, patients admitted to the corona ward at Ashrafi Khomeini Shahr Hospital affiliated to Isfahan University of Medical Sciences, who are alert and able to speak, are asked to report their daily events for -7 Complete 5 days according to the narration form. In the control group, no routine non-routine intervention is performed. Questionnaires of hope, stress, anxiety and depression will be completed before and after the intervention in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having informed satisfaction, having literacy, ability to speak, not facing severe stress during the last 6 months, no death of a family member during the last 6 months, no history of substance abuse, persistent symptoms The patient's vitality based on the patient's clinical information and the physician's diagnosis Exclusion criteria: Withdrawal from the study
Intervention groups
In the intervention group, patients admitted to the corona ward who are alert and able to speak and have stable vital signs are asked to complete their daily events for -7 to 5 days according to the narrative form . In this group, by providing a special booklet for each patient, they were taught how to write memoirs and events, so that at least once a day, daily events and events, as well as conflicts, worries and stresses in a personal booklet that It is provided to the patient to register.
Main outcome variables
Score of hope, stress, anxiety, depression

General information

Reason for update
Acronym
تاثیر روایت نویسی
IRCT registration information
IRCT registration number: IRCT20140531017920N3
Registration date: 2022-02-11, 1400/11/22
Registration timing: prospective

Last update: 2022-02-11, 1400/11/22
Update count: 0
Registration date
2022-02-11, 1400/11/22
Registrant information
Name
shahla mohamadirizi
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 910 314 2630
Email address
mohamadirizi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of “Narrative writing” on psychological health and hope in patient with covid-19
Public title
The effect of “Narrative writing” on psychological health and hope in patient with covid-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent Literacy talking No exposure to severe stress during the last 6 months No death of a family member during the last 6 months Failure to approve substance abuse Stability of the patient's vital signs based on the patient's clinical information and the physician's diagnosis
Exclusion criteria:
Participate in another study
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with coronary artery bypassed in the coronary ward are randomly assigned to one of the narrative and control (routine care) groups using the website www.random.org.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will not know how the test and control groups are assigned and will review data on outcome variables regardless of groups of individuals.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Approval date
2021-12-25, 1400/10/04
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.200

Health conditions studied

1

Description of health condition studied
corona
ICD-10 code
H05.00
ICD-10 code description
Unspecified acute inflammation of orbit

Primary outcomes

1

Description
Score of stress, anxiety, depression
Timepoint
Before and two weeks later
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, patients admitted to the corona ward who are alert and able to speak and have stable vital signs are asked to complete their daily events for -7 to 5 days according to the narration form. In this group, by providing a special booklet for each patient, they were taught how to write memoirs and events, so that at least once a day, daily events and events, as well as conflicts, worries and stresses in a personal booklet that It is provided to the patient to register.
Category
Behavior

2

Description
Control group: In the control group, patients admitted to the corona ward who are alert, able to speak, and have stable vital signs will receive routine care.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences,Isfahan,Iran
Full name of responsible person
Shahla mohamadirizi
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 910 314 2630
Email
Mohamadirizi@nm.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla mohamadirizi
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mohamadirizi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shahla mohamadirizi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mohamadirizi@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla mohamadirizi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Mohamadirizi@nm.mui.acir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla mohamadirizi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 910 314 2630
Email
Mohamadirizi@nm.mui.ac.ir

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
n
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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