The survey of effect of orientation tour with the process of surgery on anxiety in patients candidate for coronary artery bypass graft surgery: a randomized control trial
Effect of familiarization tour on the anxiety of patients undergoing coronary artery bypass graft (CABG)
Design
Clinical trials with control group, with parallel groups, single blind, randomized,
Settings and conduct
This study was an experimental study of a single-Blind controlled clinical trial to investigate the effect of the introduction tour about the process of surgery on the anxiety level of candidates for coronary artery bypass graft surgery. The studied population was the patients undergoing referred to the Shahid Chamran's heart hospital from February 2016 to May 2017.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 40 years old, complete desire and satisfaction for collaboration, undergoing coronary artery bypass graft surgery (CABG) for the first time and ready for surgery, being able to read and write in Persian to complete the questionnaire. Non-Inclusion criteria: emergency candidate for CABG, acute or chronic physical and psychiatric disorders, any speech and hearing disorders, and medicine related education.
Intervention groups
Patients in the control group will be trained by routine care by the nurse of the department on the day before the surgery. The intervention group also will be trained about the process of surgery individually through an introduction tour. A team consisting of an anesthetic technician or a nurse and the researcher will be present. This tour which will last 40 min will include visiting one of the inactive rooms, the intensive care unit and the surgical department along with talking and becoming familiar with staff and patients of the departments; education and question and answer. In the last 15 min of the tour, the intervention group will meet and talk with patients who have undergone surgery in the past.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180601039934N1
Registration date:2018-07-16, 1397/04/25
Registration timing:retrospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3458 2662
Email address
mohammadakbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of effect of orientation tour with the process of surgery on anxiety in patients candidate for coronary artery bypass graft surgery: a randomized control trial
Public title
The survey of effect of orientation tour with the process of surgery on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age over 40 years old
Complete tendency and satisfaction to cooperate in the study
Undergoing Coronary artery bypass graft surgery for the first time and ready for surgery
being able to read and write in Persian to fill the questionnaire
Exclusion criteria:
patient being an emergency case for the coronary artery bypass graft surgery
patient have acute or chronic physical and mental disorders
patient had speaking and hearing disorders
patient had education related to medical sciences.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Then subjects were divided in two groups of control (35 patients) and intervention (35 patients), using a random allocation method (by flipping a coin) and this method continued so that the number of the samples was completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data collection authorities that assessed the outcome did not have any information about the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 40,Faculty of Nursing, Isfahan University of Medical Sciences , Hezarjrib Street
City
Isfahan
Province
Isfehan
Postal code
8168196941
Approval date
2018-01-03, 1396/10/13
Ethics committee reference number
396704
Health conditions studied
1
Description of health condition studied
patients candidate for coronary artery bypass graft surgery
ICD-10 code
IX
ICD-10 code description
Diseases of the circulatory system
Primary outcomes
1
Description
anxiety in patients candidate for coronary artery bypass graft surgery
Timepoint
Measure the anxiety level of patients before intervention and before the surgery
Method of measurement
The information gathering tool is a three-part questionnaire. The first part is the demographic characteristics of the patients, the second part will be obvious anxiety and the third part of the hidden Spielberger 's anxiety.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the training about the surgery will be provided to the patients in the afternoon of the day before the surgery between 16 and 18 through a tour. In this tour, a team consisted of an anesthetist technician or a nurse and the researcher will be present. In addition, bed, DC shock, oxygen capsules and fully monitoring cardiac arrest will be present for the patients. The tour which will last 40 minutes will consist of visiting one of the inactive rooms in the evening shift of the operating room for 10 minutes, the intensive care unit for 5 minutes and the surgical section for 10 minutes along with training and question and answer frequently asked questions about the process of surgery and its problems and solutions. In the last 15 minutes of the tour, the intervention group will meet the patients who have undergone surgery in the past.
Category
Prevention
2
Description
Control group: The routine and individual training sessions will be received by the patients on the day before surgery between 16 and 18 o'clock