The Effect of Psycho-Educational Interventions on Anxiety, Physiological Indicators and Pain after the Surgery in the Coronary Artery Bypass Graft Patients
Randomized controlled clinical trial will be performed in parallel groups of phase 2 with 56 patients. A number is assigned to people with inclusion criteria. Then, using random number software, we randomly select 56 people. Using the randomized permutation block method with block size 4, we divide them into two groups of 28.
Settings and conduct
Sampling will be done in cardiac surgery wards of Shiraz University of Medical Sciences. The interventions will perform in three sessions before surgery along with giving routine sedatives face to face. There is no intervention for the control group. Anxiety, pain and physiological parameters of patients will measure by completing the Spielberger questionnaire and McGill pain scale and vital signs record sheet in both experimental and control groups during admission and after coronary artery bypass graft surgery and the results are compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
- Candidates for coronary artery bypass graft surgery
- Age between 18 to 65 years
- Willing to participate in the study
- No history of heart surgery
- Ability to read and write
- Minimum level of mild anxiety in baseline test
- No history of antidepressants use
- No physical disability and no obvious mental illness
- No history of participation in similar studies
Exclusion Criteria:
- Lack of willing to cooperate after the surgery
- Postoperative fever or infection
Intervention groups
Psycho-educational interventions will perform in three sessions before surgery as well as giving routine sedatives individually and face to face.
There is no intervention for the control group.
Main outcome variables
The effect of psycho-educational interventions on the level of pain, anxiety and physiological indicators will determine.
General information
Reason for update
Acronym
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IRCT registration information
IRCT registration number:IRCT20090908002432N8
Registration date:2021-09-17, 1400/06/26
Registration timing:registered_while_recruiting
Last update:2021-09-17, 1400/06/26
Update count:0
Registration date
2021-09-17, 1400/06/26
Registrant information
Name
Azadeh Amiri
Name of organization / entity
Shiraz University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
amiriea@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Psycho-Educational Interventions on Anxiety, Physiological Indicators and Pain after the Surgery in the Coronary Artery Bypass Graft Patients
Public title
The Effect of Psycho-Educational Interventions on Anxiety, Physiological Indicators and Pain after the Surgery in the Coronary Artery Bypass Graft Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidates for coronary artery bypass graft surgery
No history of heart surgery
Having literacy of reading and writing
Ages between 18 to 65 years
Willing to participate in the study
Participating in pre-test assessment and having a minimum level of mild anxiety
No history of antidepressants use
No physical disabilities and no mental illnesses
No participation in similar studies
Exclusion criteria:
Lack of cooperation after the surgery
Postoperative fever and infection
Any problems during anesthesia and surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
First, we will pick up the people who has the inclusion criteria based on their profiles and get a number to each one. Then, we will randomly select 56 of them with the random number software. We will use the randomized permutation block design with the size of 4 to allocate them into the two groups of intervention (n=28) and control (n=28).
Blinding (investigator's opinion)
Double blinded
Blinding description
Control and intervention group members should not be in the same room or close to each other so that the sound of training would not heard by the control group. We will ask the control group not to share the training with other patients.
Placebo
Not used
Assignment
Parallel
Other design features
The present study is performed on 56 patients volunteered for coronary artery bypass graft surgery who are eligible to enter the study. Samples were selected through target-based sampling method until reaching the desired sample size and then samples were divided into two groups of experimental and control by random allocation method using RA software. Psycho-educational interventions were placed in three training sessions in the morning or evening the day before surgery and routine sedatives were given individually and face to face. Brochures were given to patients for study. Educational interventions included (effective breathing exercises after heart surgery and the way to use spirometry, self-care training and nutritional care after surgery, giving information about the process of the disease and treatment, routine medications after surgery and their side effects, surgery site, stitches and chest tube care training). Psychological interventions included: five mindfulness exercises trainings (conscious breathing, conscious observation, conscious listening, conscious awareness, conscious appreciation). There is no intervention for the control group. Spielberger questionnaire and McGill inventory will completed by the patient after surgery and before discharge. Physiological parameters of the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz.
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2021-05-27, 1400/03/06
Ethics committee reference number
1400.175.IR.SUMS.REC
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Physiological indexes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of anxiety
Timepoint
Before intervention, during admission and after intervention
Method of measurement
Spielberger state-trait anxiety questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
Before intervention, during admission and after intervention
Method of measurement
McGill Scale
Intervention groups
1
Description
Intervention group: Psycho-educational interventions will perform in 3 sessions alongside prescribing routine sedatives face to face before surgery. An educational brochure will give to patients. Educational interventions are including effective breathing exercises after heart surgery, spirometer use techniques, self-care training, nutritional care after surgery, giving information about the course of disease and treatment, routine medications after surgery and their side effects, training to take care of the surgical site, stitches and chest tube. Mental interventions including conscious breathing, conscious observation, conscious listening, conscious mindfulness, conscious appreciation.
Category
Other
2
Description
Control group: There is no intervention for the control group. Spielberger questionnaire and McGill inventory will completed by the patient after surgery and before discharge. Physiological parameters of the patients will measure and record by the research assistant.