Protocol summary

Study aim
Effect of Nursing Counseling and Mental Imaging on Stress and Anxiety in Patients With Coronary Angiography
Design
It consists of three groups. Control group, intervention group for nursing counseling, intervention group for mental imagery
Settings and conduct
Ali Ibn Abi Talib Hospital of Zahedan Special Heart Department
Participants/Inclusion and exclusion criteria
Patients Candidate for Coronary Angiography, with Age Between 30 and 60 Years, Coronary Angiography, Non-Emergency Angiography
Intervention groups
Two intervention groups, one group Nursing counseling intervention, one group mental intervention intervention group
Main outcome variables
Stress, Anxiety, Nursing Counseling, Mental Imaging

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200109046062N1
Registration date: 2020-01-18, 1398/10/28
Registration timing: retrospective

Last update: 2020-01-18, 1398/10/28
Update count: 0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Malihe Nikfarjam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 1760
Email address
malih.niki65@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nursing Counseling and Mental Imaging on the Stress and Anxiety of Patients Candidate for coronary Angiography
Public title
Effect of Nursing Counseling and Mental Imaging on Stress and Anxiety in Patients With Coronary Angiography
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 and 60 years Minimum literacy Having a coronary angiography recipe
Exclusion criteria:
Emergency coronary angiography instruction Acute pain associated with cancer and other irrelevant diseases She has already been angiographed
Age
From 30 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, Individual randomization, Coin toss
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 Zabol University of Medical Sciences
Street address
Zabol University of Medical Sciences, Shahid Bagheri Street
City
Zadol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.ZBMU.REC.1397204

Health conditions studied

1

Description of health condition studied
Stress, Anxiety, Patients Candidate for Coronary Angiography
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Stress
Timepoint
Before the intervention, one hour before angiography
Method of measurement
Dass21 questionnaire

2

Description
Anxiety
Timepoint
Before the intervention, one hour before angiography
Method of measurement
Dass21 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Completion of the questionnaire, Nursing consultation, Completion of the questionnaire one hour before angiography
Category
Prevention

2

Description
Intervention group: Completion of the questionnaire first, mental imaging, completing the questionnaire again one hour before angiography
Category
Prevention

3

Description
Intervention group: Without consulting and mental imagery
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali in Abi Talib Hospital
Full name of responsible person
Abdalgani abdullahi
Street address
Khalij Fars Boulevard, Ali ibn Abi Talib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
abdalqani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdalqani Abdullahi
Street address
Ferdowsi street, Ferdowsi 11 alley, school of Nursing and Midwifery
City
Zabul
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
abdalqani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Abdul Ghani Abdollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ferdowsi street, Ferdowsi 11 alley, school of Nursing and Midwifery
City
Zabul
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
+98 54 3223 2023
Email
abdalqani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdul Ghani Abdollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ferdowsi street, Ferdowsi 11 alley, school of Nursing and Midwifery
City
Zabul
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
+98 54 3223 2023
Email
abdalqani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdul Ghani Abdollahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Zabul, Ferdowsi street, Ferdowsi 11 alley, School of Nursing and Midwifery.
City
Zabul
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Fax
+98 54 3223 2023
Email
abdollahi@zbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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