| CTRI Number |
CTRI/2026/04/108305 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [pre operative education] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of pre operative education program on comfort, anxiety and patient–ventilator synchrony among post CTVS surgery patients. |
|
Scientific Title of Study
|
A randomized control trial to assess the effects of a preoperative education program on comfort, anxiety and patient–ventilator synchrony among post CTVS surgery patients admitted in the CTVS department at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shagun Singh |
| Designation |
M.Sc. Nursing (Cardiological/CTVS Nursing) |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Porta Cabin 2, near old OT Block
South
DELHI
110029
India |
| Phone |
9873414594 |
| Fax |
|
| Email |
shagun.singh789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing,2nd floor , near old OT Block,AIIMS
South
DELHI
110029
India |
| Phone |
9871755975 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shagun Singh |
| Designation |
M.Sc. Nursing (Cardiological/CTVS Nursing) |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing, Porta Cabin 2, near old OT Block
South
DELHI
110029
India |
| Phone |
9873414594 |
| Fax |
|
| Email |
shagun.singh789@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shagun Singh |
| Address |
College of Nursing, Porta Cabin 2, Near old OT block, AIIMS,Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSmita Das |
AIIMS, New Delhi |
CTVS ICU, CT4 ward, cardio neuro center, AIIMS, New Delhi
South
DELHI |
9871755975
smitadas307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I35||Nonrheumatic aortic valve disorders, (3) ICD-10 Condition: I34||Nonrheumatic mitral valve disorders, (4) ICD-10 Condition: I06||Rheumatic aortic valve diseases, (5) ICD-10 Condition: I05||Rheumatic mitral valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preoperative education program |
Preoperative education begins with welcoming the patient, introducing oneself, and explaining the purpose of the session, which is to prepare the patient for surgery, reduce anxiety, and encourage recovery. Trust and open communication are established, and the patient is reassured of continuous support. Information is provided about the planned surgery, including whether it is CABG, valve surgery, or a combined procedure, along with the expected duration. The patient is then oriented to the ICU environment, including monitors, alarms, lights, and noise, with reassurance about safety. Education on mechanical ventilation includes visualization of the endotracheal tube, its purpose in supporting breathing during recovery from anesthesia, the expected duration of 6–24 hours, and the inability to speak while it is in place. Alternative communication methods are explained, and the importance of staying calm, cooperating with the ventilator, and allowing it to assist breathing is emphasized, with assurance of nurse support. The patient is informed about other tubes and lines, monitoring equipment, and transfer to a step-down unit once stable. Postoperative care teaching focuses on the importance of deep breathing and coughing to prevent lung complications, with demonstration and practice of deep breathing, incentive spirometry, effective coughing, and chest splinting. The session concludes with a brief summary using the teach-back method to confirm understanding of postoperative expectations and breathing techniques, preoperative education will last for 45-50 mins |
| Comparator Agent |
STANDARD CARE |
STANDARD INFORMATION AS PER INSTITUTION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having
Age 18-60 years
2. Scheduled for elective cardiac surgery (CABG, valve replacement or repair, combined procedures)
3. Expected to require postoperative mechanical ventilation
4. Ability to understand and communicate in Hindi or English
5. Conscious and oriented (Glasgow Coma Scale score equal to 15)
6. Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 or more than 60
2. Emergency or urgent cardiac surgery
3. Documented psychiatric disorders or currently on psychiatric medications
4. Severe cognitive impairment or diagnosed dementia
5. Hearing or visual impairments that preclude participation in education
6. Previous cardiac surgery (redo procedures)
7. Severe preoperative hemodynamic instability requiring inotropic support or intra-aortic balloon pump
8. Illiterate with no family member available to assist
9. Participation in another interventional research study
10. Preoperative mechanical ventilation
11. History of smoking, COPD or other severe comorbidities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comfort, anxiety and patient ventilator synchrony |
30 mins after waking up from sedation, 30 mins after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the duration of mechanical ventilation between intervention group & control group |
baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of a structured preoperative education program on comfort, anxiety, and patient–ventilator synchrony among patients undergoing elective cardiothoracic and vascular surgery (CTVS) at AIIMS, New Delhi. Preoperative anxiety and postoperative discomfort are common in cardiac surgery patients and are known to contribute to patient–ventilator asynchrony, prolonged mechanical ventilation, and adverse ICU outcomes. The study seeks to generate evidence to support non-pharmacological, nurse-led interventions that enhance perioperative care. A quantitative randomized controlled design will be adopted. Adult patients aged 18–60 years scheduled for elective CTVS procedures and expected to require postoperative mechanical ventilation will be enrolled after obtaining informed consent. Eligible participants will be randomly allocated to an intervention group or a control group. The intervention group will receive a structured, nurse-delivered preoperative education program 24–48 hours before surgery, covering the ICU environment, mechanical ventilation, postoperative expectations, coping strategies, and breathing exercises, while the control group will receive routine care. Postoperatively, comfort and anxiety will be assessed using validated self-structured questionnaires, and patient–ventilator synchrony will be evaluated using the asynchrony index. Data will be analyzed using appropriate descriptive and inferential statistics to determine the effectiveness of the intervention.
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