this study will determine the effect of guided reflection on self-care and medical adherence in patients undergoing Coronary Artery Bypass Graft.
Design
One arm parallel group randomized trial with blinded postoperative care and outcome assessment on 94 patients.The 4-volume block method is used to generate a random allocation sequence.
Settings and conduct
In order to access and select the samples, The researcher refer to the CCU unit first and after entering the environment, while introducing oneself to patients undergoing coronary artery surgery who has the inclusion criteria, explaining the study objectives, importance, reason of performing the research, how to perform the research and Informed written consent will be obtained. Data collectors and data analyzer and clinical caregivers are blinded and will not be aware that how individuals are assigned to groups. the data collector will be a trained expert nurse who does not know how patients are allocated.
Participants/Inclusion and exclusion criteria
Inclusion criteria include no history of coronary artery bypass graft surgery, ability to communicate verbally, age range 30 to 75 years. Exclusion criteria is Patients with Cognitive impairment.
Intervention groups
Guided reflection, which includes several stages, will be explained to the patients in the exam group, and based on it and the questions that are asked in each stage, the person will discuss the situations and events that he/she has faced and his/her feelings. Express their positive and negative feelings about it and takes steps to better understanding and planing for A better performance in similar situations that are predicted in the future. In control group, they will have routine trainings of the clinic (Includes presentation of medication pamphlet and oral training by physician and nurse).
Main outcome variables
Self care؛ Medical adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200907048645N1
Registration date:2020-09-19, 1399/06/29
Registration timing:registered_while_recruiting
Last update:2020-09-19, 1399/06/29
Update count:0
Registration date
2020-09-19, 1399/06/29
Registrant information
Name
Elahe Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3323 2866
Email address
elahe2941@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of guided reflection on self-care and medical adherence in patients undergoing Coronary Artery Bypass Graft
Public title
Effect of guided reflection on self-care and medical adherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
lack of experiencing CABG surgery before
Ability to communicate verbally
Between 20 to 60 years old
Exclusion criteria:
Patients with Cognitive impairment
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The 4-volume block method is used to generate a random allocation sequence. Patients will be selected according to the criteria of the researcher and by sequential sampling method and will be randomly divided into two groups A and B. This means that a number of sealed envelopes are prepared, each containing an A or B code. The researcher takes the desired envelope in the specified order and acts according to the group registered in the envelope. It is determined in which group each patient will be placed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data collectors and data analyzer and clinical caregivers are blinded and will not be aware that how individuals are assigned to groups. In this way, the data collector will be a trained expert nurse who does not know how patients are allocated. Participants and researchers are not blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
Shahrood medical univercity, 7 tir Sq
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.SHMU.REC.1399.101
Health conditions studied
1
Description of health condition studied
coronary artery bypass graft
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris
Primary outcomes
1
Description
Self care
Timepoint
Self-care will be measured at the beginning of the study, before the intervention, and six weeks after the intervention.
Method of measurement
Cardiac Patients' Self-Care Questionnaire Validated by Khodaminasab et al
2
Description
Medical adherence
Timepoint
Medical adherence will be measured at the beginning of the study, before the intervention, and six weeks after the intervention.
Method of measurement
Morisky medical adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Guided reflection, which includes several stages, will be explained to the patients in the experimental group, and based on it and the questions that are asked in each stage, the person will discuss the situations and events that he/she has faced And expresses his positive and negative feelings about it and Steps are taken to better understand and plan for better performance in similar situations that are predicted in the future.
Category
Rehabilitation
2
Description
Control group:related to the control group, they will have routine trainings in the clinic and ward (including providing medical pamphlets and oral training by a doctor and nurse).