1.Objectives: The object of study is determining the effect of multimedia education on the anxiety and physiological indexes of patients who candidate for cerebral angiography.
2.Design: The study design is randomized controlled trial.
3.Setting and conduct: The intervention group will receive multimedia education on the angiography, and the control group routine care only (of course the intervention group will also receive routine care) in Firouzgar hospital located in Tehran. Physiological indexes for all patients will be measured every two hours before and after the intervention. Also, the anxiety with state anxiety questionnaire before and after the intervention will be investigated.
4.Participants: 88 patients who are candidates for cerebral angiography or angioplasty and have including criteria will form the study sample. If they do not want to continue their research, Loss of consciousness or death will be excluded.
5.Intervention: The intervention is multimedia education that will include educational movie (video), educational pamphlets (booklet), verbal education, and answers to asked questions by patients. These educations provide information on pre-angiography readiness, the conditions and equipment needed in the angiographic room, how to perform angiography, post-angiography care, and home care tips. A multimedia education will be conducted by one of the researchers for at least 30 minutes for patients and at a place which consider for patients education.
6.Main outcome variables: Physiological indexes and the anxiety are the main outcome measures of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080335479N1
Registration date:2017-10-04, 1396/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Leila Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4322
Email address
l-sayadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS)
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimedia education on anxiety and physiological indexes in patients candidate for cerebrovascular angiography
Public title
The effect of multimedia education on anxiety and physiological indexes
Purpose
Other
Inclusion/Exclusion criteria
Patients participating in the study will have the following characteristics: • For the first time candidates for vascular catheterization, • At least 16 years of age, • Speak in Persian. • Ability to read and write and able to complete the questionnaire; • Satisfy the study; • During cerebral angiography; they have not received sedative medications; • They are not part of the hospital staff and are not familiar with cerebrovascular angiography; • Emergency needs; Do not have a catheterization of the cerebrospinal• Have no previous history of brain or cardiac catheterization; • Have no cognitive impairment; • Do not receive drugs for psychiatric disorders / benzodiazepines or anxiolytic drugs; • Steroids and substances Drugs do not consume; • Do not have blindness and severe hearing / hearing impairment; • Do not have chronic or life-threatening illnesses (such as cancer); •Do not require admission to specialized care because of their conditions; • Pre-admission patients have special training in no association with cerebral angiography • There are no hormonal disorders associated with thyroid, adrenal gland, and pituitary.
Exclusion criteria: Do not wish to continue research. The patient dies during or after angiography. The patient has a loss of consciousness.
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
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
School of Nursing & Midwifery, Tehran University of Medical Sciences, Nursing Ethics Committee
Street address
Mirkhani St (East Nosrat), Tohid Sq
City
Tehran
Postal code
141973317
Approval date
2017-07-30, 1396/05/08
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2995
Health conditions studied
1
Description of health condition studied
cerebrovascular angiography
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
anxiety
Timepoint
before and after intervention
Method of measurement
Spielberger State Anxiety Inventory (SAI)
2
Description
blood pressure (Systolic, diastolic)
Timepoint
before and after intervention - from admission to discharge- q2hours
Method of measurement
mmHg - monitoring blood pressure
3
Description
heart rate
Timepoint
before and after intervention - from admission to discharge- q2hours
Method of measurement
beats per minute in the monitoring that is attached to patient
4
Description
respiratory rate
Timepoint
before and after intervention - from admission to discharge- q2hours
Method of measurement
breaths per minute in the monitoring that is attached to patient
5
Description
tempreture
Timepoint
before and after intervention - from admission to discharge- q2hours
Method of measurement
Centigrade - °C- Temperature is shown by thermometer
6
Description
Oxygen saturation
Timepoint
before and after intervention - from admission to discharge- q2hours
Method of measurement
pulse oximeters-A finger pulse oximeter that is attached to patient
Secondary outcomes
empty
Intervention groups
1
Description
The intervention of this study will be multimedia education. Multimedia education in this study will consist of movie (video), educational pamphlet (booklet), oral education and answers to questions posed by patients. The following is an explanation of each component of multimedia learning. (A) Educational movie (video): The content of the video includes information on the pre-angiography readiness, the conditions and equipment needed in the angiographic room, the way angiography is performed, the care required after angiography. Also, the things that need to be considered after taking out hospital care are provided in this video tutorial. This video will be made using Adobe Premiere. The film begins providing information about the preparation for angiography and will end with the necessary care after discharge from the hospital and at home. The film will use images and animations related to angiography and will be called by one of the researchers. The contents of the educational and video materials will be based on the resources and standards related to the cerebrovascular angiography, and after the approval of the professors of the faculty of internal medicine and the neuroscience department will be used for training. B) Educational pamphlet (booklet): In the educational pamphlet, the content of the movie displayed to patients will be summarized in a written and color-coded form with pictures for patients. This booklet will be available to patients for reading. C) verbal education: verbal education will provide patients with information on cerebrovascular angiography, how to do it and its related care as a lecture and verbal to the candidate for cerebrovascular angiography. D) Answering patient questions: At the end, patients are requested to ask questions if they need additional information, as well as express their concerns. Their questions will be answered and the relevant information will be provided to them. Intervention in the intensive care unit will be performed on the cerebral angiography in Firoozgar Hospital. After admission to this section, patients will be prepared for brain angiography. Intervention at the time of hospitalization in patients and at least 30 minutes in a room designed to patients education. Since cerebrospinal angiography is performed in the morning and afternoon shifts and on non-holiday days, interventions will take place in the morning and evening shifts of non-holiday days.
Category
Other
2
Description
The control group will not receive any educational intervention. This group will receive only the routine method in the department. Routine measures include: a) informed consent of patients about performing angiography; b) cleaning the skin; insertion of the catheter; c) taking the peripheral vessel; d) administering the drug in accordance with the relevant physician's orders; c) monitoring the vital signs every two hours before and after cerebral angiography.