Effect of angioplasty procedure movie watching on illness perception and anxiety of patients undergoing elective PCI in Imam Khomeini Hospital, 2015-2016
Introduction and objectives: with regarding to that, angioplasty cause anxiety in patients and the anxiety can be affected the mental health, healing and keeping the health situation, we decided to assess the Effect of angioplasty procedure movie watching on illness perception and anxiety of patients undergoing elective PCI in Imam Khomeini Hospital, 2015-2016.
Material and methods: this is a single blind clinical trial study that were done on the patients undergone angioplasty procedure in Tehran Imam Khomeini Hospital. The sampling based on random number table. The patients divided to the two groups( each group 30 patients) and the angioplasty procedure film was showed to the only one group( intervention group) after the operation. Matching was done by group matching method. Inclusion criteria was the patients aged between 40-65 years old and exclusion criteria was the history of psychological disorders and hypo or hyperthyroidism. It was filled the check list including demographic data and clinical presentation, Beck 21 anxiety questionnaire and brief illness perception 8 questionnaire for each patient immediately after the intervention and one month later. In the last visit the patients answer the checklist about their complications.
General information
Acronym
PCI : percutaneous coronary intervention
IRCT registration information
IRCT registration number:IRCT2017021932666N1
Registration date:2017-08-13, 1396/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Maryam Jalalsafari
Name of organization / entity
Tehran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 0564
Email address
jalalsafari.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Funding sources providing the researcher
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of angioplasty procedure movie watching on illness perception and anxiety of patients undergoing elective PCI in Imam Khomeini Hospital, 2015-2016
Public title
Effect of angioplasty video show on the patient's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria was the patients between aged 40 - 65 years old that undergone coronary angiography and candidate for elective PCI. Exclusion criteria were the patients refused cooperation in this study; the history of psychological disorders or hospitalization because of that, hypo or hyperthyroidism without treatment; occurrence of complications after angioplasty or before the second visit; age under 40 of over 65 years old; illiterate persons; the patients with the history of previous angiography; heart failure with ejection fraction below 30% and the CAD patients candidate for medical treatment.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Scienses
Street address
Tehran University of Medical Scienses, Ghods St, Poursina St, north door, Building No.1
City
Tehran
Postal code
1417613151
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1669
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
Anxiety
Timepoint
At discharge time and one month later
Method of measurement
Beck anxiety questionnaire
2
Description
Illness perception
Timepoint
At discharge time and one month later
Method of measurement
BIPQ questionnaire
Secondary outcomes
1
Description
Exertional dyspnea
Timepoint
Before and after procedure
Method of measurement
NYHA Class(1/2/3/4)
Intervention groups
1
Description
angioplasty procedure video show in case group
Category
Prevention
2
Description
Not show angioplasty video in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital complex
Full name of responsible person
Dr. Maryam Jalal Safari
Street address
End of Keshavarz Blv, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart center
Full name of responsible person
Dr. Babak Geraiely
Street address
Tehran Heart center, North Kargar St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Heart center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalal Safari
Position
MD/ Cardiology resident
Other areas of specialty/work
Street address
Imam khomeini Hospital complex, Keshavarz blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
+98 21 6658 1615
Email
jalalsafari.M@gmail.com
Web page address
Imamhospital@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalal Safari
Position
MD/ Cardiology resident
Other areas of specialty/work
Street address
Imam khomeini Hospital complex, Keshavarz blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
+98 21 6658 1615
Email
jalalsafari.M@gmail.com
Web page address
Imamhospital@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Maryam Jalal Safari
Position
MD/ Cardiology resident
Other areas of specialty/work
Street address
Imam khomeini Hospital complex, Keshavarz blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 61190
Fax
+98 21 6658 1615
Email
jalalsafari.M@gmail.com
Web page address
Imamhospital@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)