Investigating the effect of telephone -based orientation during waiting time, on anxiety of patients undergoing coronary angiography referring to Ali Ibn Abitaleb hospital of Rafsanjan
Determination the effect of telephone -based orientation during waiting time, on anxiety of patients undergoing coronary angiography referring to Ali Ibn Abitaleb hospital of Rafsanjan
Design
Two arm parallel group randomized clinical trial
Settings and conduct
In this randomized clinical trial, the study population are elective candidates for coronary artery angiography who will referred to Ali Ibn Abitaleb Hospital of Rafsanjan. Participants will select by convenience sampling method based on inclusion criteria of the study. Random allocation of the participants will carry out using the minimization method based on age and sex variables. Participants will be divided into two groups of intervention (will receive telephone -based orientation intervention in addition to routine care) and control (will receive routine care). Demographic questionnaire and the Spielberger anxiety questionnaire are data collection tool which will completed at the time of admission, one hour before angiography and two hours after angiography in both control and intervention groups.
Participants/Inclusion and exclusion criteria
Consent to participate in the study, age 35-60 years old and good hearing and visual acuity are inclusion criteria. Addiction, history of angiography, history of mental illness, taking tranquilizers in routine or during waiting time, and membership of a patient or his or her family members in the health care team are exclusion criteria.
Intervention groups
Intervention group: will receive telephone -based orientation intervention in addition to routine care.
Control group: will receive routine care.
Main outcome variables
score of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150713023190N7
Registration date:2018-12-30, 1397/10/09
Registration timing:prospective
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of telephone -based orientation during waiting time, on anxiety of patients undergoing coronary angiography referring to Ali Ibn Abitaleb hospital of Rafsanjan
Public title
The effect of telephone -based orientation during waiting time, on anxiety of patients undergoing coronary angiography
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent for participate in the study
Age 35-60 years old
Good hearing and visual acuity
Exclusion criteria:
Addiction
History of angiography
History of mental illness
Taking tranquilizers in routine or during waiting time
Membership of the patient or his/her first-degree family members in the health-care team
Age
From 35 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random stratification by minimization method based on age and sex variables
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 committe of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.RUMS.REC.1397.162
Health conditions studied
1
Description of health condition studied
Angiography
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
Anxiety score based on Spielberger questionnaire
Timepoint
In the admission time, one hour before angiography and two hours after angiography
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine care, patients will receive telephone based orientation intervention (two 10-minute sessions on the day after the appointment for angiography and the day before the angiography). This intervention include descriptions of the angiographic process, how to proceed, the duration of angiography, pre and post-angiography preparation , time back to ward, common nursing care for angiography patients, how to communicate with a doctor and nurses, discharge time from angiography, bed rest after angiography, home care and hospitalization.
Category
Other
2
Description
Control group: will receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital
Full name of responsible person
Ali Mousavi
Street address
Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
aliebn@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Shamsi Zadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0027
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Maryam Shahpari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mofateh Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0001
Email
mshahpari55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
Email
t.b_sadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
Email
t.b_sadeghi@yahoo.com
Web page address
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
Confidentiality of data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available