Determining the effect of care with a human approach on the angiography patients' anxiety level and hopelessness
Design
Interventional study , Clinical trial with control group, parallel groups, consecutive non-probability sampling, without blinding, Sample size is 30 individuals in each group.
Settings and conduct
In this clinical trial, 60 patients candidates of angiography were selected non randomly consecutive and divided into two groups of control and intervention (30 subjects in each group). Data gathering tool was Personal and Clinical Questionnaire, Beck Anxiety Inventory(BAI) and Beck Hopelessness Scale (BHS). Anxiety and hopelessness questionnaire completed by participants at two occasions: two to three days before and the night before angiography.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-angiography for the first time. 2-Patients admitted for at least 2 to 3 days before angiography. 3-Age 40 and 75 years. 4-communicate verbally in Persian or Lori dialect. 5-Stability of the physical, mental and psychological state. Exclusion criteria: 1-Receiving corticosteroids, sedative medicines and anxiolytic drugs during 72 hours before the study. 2-History of depression and anxiety disorders. 3-The existence of crises affecting life over the past six months. 4-History of Heart Surgery, Thyroid Disorders and Epilepsy. 5-Emergency angiography
Intervention groups
the control group: will receive the usual or routine care. Routine control includes receiving medicine, sending laboratory tests, performing chest graph, shaving the catheter insertion place, etc.
the intervention group:relationship-based care, based on a content developed according to the 10 carative factors of Watson's theory, is built two or three days before angiography in three sessions.The length of each session varies according to patients' needs.
Main outcome variables
Anxiety and Hopelessness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180612040074N1
Registration date:2019-03-07, 1397/12/16
Registration timing:retrospective
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
Mojgan Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 0592
Email address
khademi.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-26, 1397/04/05
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care with a human approach on anxiety and hopelessness of patients candidate for coronary angiography
Public title
The effect of care with a human approach on anxiety and hopelessness
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for the first angiography operation
Patients admitted for at least 2 to 3 days before angiography
Age between 40 and 75 years
Ability to communicate verbally in Persian or Lori dialect
Stability of physical, mental and psychological conditions
Exclusion criteria:
Receiving corticosteroids, sedative medications and anxiolytics such as propranolol 72 hours before the study
History of depression and anxiety disorders
Experiencing serious crisis during the previous six months (including the death of close relatives, suffering from life-threatening illnesses, or close relative's serious illnesses, etc.)
History of heart surgery, thyroid disorders, epilepsy and respiratory distress .
Emergency Angiography
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Lorestan University of Medical Sciences
Street address
Integrated Lorestan Medical Sciences- opposite to the Kahrizak village- km 5 Road of Khorram Abad- Boroujerd
City
Khoramabad
Province
Lorestan
Postal code
6814993165
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.LUMS.REC.1397.035
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Two to three days before angiography and the night before angiography before and after intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Hopelessness
Timepoint
Two to three days before angiography and the night before angiography and before and after intervention
Method of measurement
Beck Hopelessness Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: if the patient is in the intervention group, relationship-based care, based on a content developed according to the 10 carative factors of Watson's theory, which is confirmed by Nursing Specialists, is built two or three days before angiography in three sessions (each day one session is scheduled). The length of each session varies according to patients' needs.
Category
Prevention
2
Description
Control group: if the patient is in the control group, she/he will receive the usual or routine care. Routine control includes receiving medicine, sending laboratory tests, performing chest graph, shaving the catheter insertion place, etc.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorramabad Hospital of Shahid Madani
Full name of responsible person
Dr. Gholamreza Beyranvand
Street address
Imam Hussein Square, Khorram Abad
City
Khoramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3340 6098
Email
madani@domain.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mojtaba Khaksariyan
Street address
Integrated Lorestan Medical Sciences- opposite to the Kahrizak village- km 5 Road of Khorram Abad- Boroujerd
City
Khoramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3312 0165
Email
mojkhaksar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Malasadi
Position
Graduate student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Integrated Lorestan Medical Sciences- opposite to the Kahrizak village- km 5 Road of Khorram Abad- Boroujerd
City
Khoramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3321 7426
Email
fatemeh.malasadi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Malasadi
Position
Graduate student of Medical- Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Integrated Lorestan Medical Sciences- opposite to the Kahrizak village- km 5 Road of Khorram Abad- Boroujerd
City
Khoramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3321 7426
Email
fatemeh.malasadi1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Malasadi
Position
Graduate student of Medical- Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Integrated Lorestan Medical Sciences- opposite to the Kahrizak village- km 5 Road of Khorram Abad- Boroujerd
City
Khoramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3321 7426
Email
fatemeh.malasadi1372@gmail.com
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
The participant data file will remain confidential
Study Protocol
Yes - There is 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
Title and more details about the data/document
Intervention study protocol
When the data will become available and for how long
After the publication of the study protocol is available
To whom data/document is available
The study protocol is published
Under which criteria data/document could be used
The protocol can be used to use and use the theory
From where data/document is obtainable
The study protocol is published
What processes are involved for a request to access data/document