Influence of phase one cardiac rehabilitation on delirium after coronary artery bypass graft surgery
Design
This study is a randomized clinical trial with two groups of intervention and control. The sample size is 30 patients for the intervention group and 30 patients for the control group. Statistical analysis was performed using SPSS software version 20.
Settings and conduct
This study was performed on patients admitted to the open heart surgery intensive care unit and open heart surgery ward of Imam Reza Hospital in Imam Reza Square who undergo coronary artery bypass surgery.
Participants/Inclusion and exclusion criteria
1. over 18 years of age 2. lack of history of heart surgery 3. no history of known medical illness based on medical records 4. no motor impairment that prevents walking 5. no history of delirium 6. no use of medications Preoperative psychiatric and sedative 7. Having a RASS score of zero means that the patient is alert and can cooperate with the researcher.
Intervention groups
Phase one cardiac rehabilitation, two to three times a day for 20 to 30 minutes at a time, according to the Ministry of Health guidelines, which consists of three parts: 1. Respiratory exercise training and control by the researcher; 2. Discussion with the patient; 3. The patient was encouraged to perform activities for the intervention group.The control group received routine care.
Main outcome variables
Incidence and severity of delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191224045878N1
Registration date:2020-02-19, 1398/11/30
Registration timing:retrospective
Last update:2020-02-19, 1398/11/30
Update count:0
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
kolsoom parnan emamverdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2535
Email address
parnanek951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2019-12-21, 1398/09/30
Scientific title
The effect of Phase I Cardiac Rehabilitation on the Rate of Delirium in Patients After Coronary Arteyry Bypass Graft Surgery
Public title
The effect of Phase I Rehabilitation on the Delirium in Cardiac Surgery Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be in a Group over the 18 Years
Do not use the Psychiatric or Antirelaxant Medications
Do not have a Histiry of Heart Surgery
Do not have a Movement Problem
Do not have a History of Delirium
Having a Score 0 From RASS means the patients is calm and relax and able to cooperative with researcher
Do not have a Known psychiatric Disease
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this Research, Inclusion of research units in the Study, The Method is Available and Random Allocation. Random Sequence Tool is SPSS. Random Sequence Was Prepared as a Table.It was Kept in an envelope.After making sure everyone is eligible, Envelope door Opened And The Sequence was assigned to that Group
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Intersection Doctorate, Ibn Sina St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-10-25, 1398/08/03
Ethics committee reference number
IR.MUMS.REC.1398.156
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft
ICD-10 code
F05.8
ICD-10 code description
Postoperative Delirium
Primary outcomes
1
Description
Delirium
Timepoint
Since the End of the Endotracheal Tube Up to 5 to 7 days after ُSurgery
Method of measurement
Neecham Tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals find the phase of a cardiac rehabilitation based on a Ministry of Health instruction that consists of three parts, including: 1. Exercise training and control by the researcher; 2. Discussion with the patient; 3. The patient was encouraged to perform activities for the intervention group. Exercise should be performed two to three times a day for at least 20 minutes and a maximum of 30 minutes. Then, according to the protocol of the Ministry of Health for 15 to 20 minutes, chest physiotherapy was performed. After chest physiotherapy, depending on whether the patient was in a supine position, sitting or standing, appropriate exercises were performed for the patient. At each exercise session, about 5 to 10 minutes to warm up, 5 to 10 minutes to cool and 20 to 30 minutes to exercise. Chest physiotherapy was given 15 to 20 minutes per session. In addition, diaphragmatic breathing training was performed face-to-face with the aid of image and shape, and the subjects performed exercise at least once a day in the presence of the researcher, and the next time, the patient performed the exercise alone. And to control gestures, the researcher was assisted in various shifts to monitor her performance as well as the accuracy of the exercise. In step two, the benefits of the cause and the disadvantages and overall self-care were described to the patient. Possible questions and uncertainties about surgery, diet, medications, post-operative rest, risk factors control, time to start daily activities, and marital relationships were answered and the patient was asked about any concerns and concerns. The researcher points out. In step three, the patient was used to encourage verbal communication and positive feedback to him and his family, such as good, effective, excellent in the presence of the patient. This rehabilitation started from the end of the endotracheal tube and continued for 5 to 7 days until the end of the open heart session. The control group received routine nursing interventions in the ward and in both the control and intervention groups, the scale (Nicham) was completed, measured and compared daily to assess the incidence of delirium at the same time.
Category
Rehabilitation
2
Description
Control group: In addition to receiving routine care, at the end of two weeks, a control booklet was administered to patients in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Open heart surgery intensive care unit and open heart surgery unit in Imam Reza hospital in Mashhad
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Presentation of research findings in seminars, conferences, and publication of articles extracted from research in domestic and overseas journals, all hospitals, and even other departments, especially after surgical operations requiring the use of specific medications following psychologic complications. Have surgery, be used As well as researchers who intend to conduct research on the subject.
When the data will become available and for how long
Start of course available 6 months after printing results
To whom data/document is available
Share the results of the research with other researchers for further research
Under which criteria data/document could be used
Used in all hospitals and even in other wards, especially after surgeries that require the use of specific medications in the aftermath of psychologically induced complications.
From where data/document is obtainable
Visit to Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
After the email is sent to the scientific respondent, the accountability process begins