Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
NCT06881212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-03-18
Summary
This study was conducted to understand how training given to patients before and after open-heart surgery affects their reactions during intubation (when a breathing tube is inserted), their agitation levels, and the time it takes to remove the breathing tube.
Study Design
The research followed a quasi-experimental design, meaning patients were divided into two groups:
Experimental Group - Received special training before and after surgery. Control Group - Received standard hospital care without additional training. Key Variables Independent Variable (What was changed): The training given before and after surgery.
Dependent Variables (What was measured):
Patient reactions during intubation Agitation levels Time taken to remove the breathing tube Study Hypotheses Patients who received the training would show different reactions compared to those who did not.
1.1. The trained group would show fewer negative reactions during intubation. Patients who received the training would have different agitation levels compared to the control group.
2.1. The trained group would be less agitated. The time taken to remove the breathing tube would be different between the two groups.
3.1. The trained group would have their breathing tube removed faster. Where and When Was the Study Conducted? The research took place at Bezmialem Vakif University Hospital in Istanbul in the cardiovascular surgery department, between October 10, 2022 - January 7, 2023.
Participants The study initially considered 123 patients who had undergone open-heart surgery during this period.
Patients were selected based on certain health conditions and criteria (age, no chronic respiratory disease, type of surgery, etc.).
After applying these criteria, 30 patients (15 in each group) were included in the final study.
How Were Patients Selected? To ensure fairness, patients were randomly assigned to either the experimental or control group.
A computer-generated random list was used to assign them. Who Was Included in the Study? Patients who had Coronary Artery Bypass (CABG), Aortic Valve Replacement (AVR), or Mitral Valve Replacement (MVR) surgery.
Patients aged 45-70 years old. Who Was Excluded? Patients with chronic respiratory disease (as it could affect intubation time). Patients who had previous open-heart surgery (as prior experience could influence their reaction).
Patients who did not speak Turkish or had cognitive issues. Patients with severe psychiatric conditions. Data Collection \& Training Process
Before the surgery:
Patients were asked about their age, gender, smoking habits, medical history, and other factors.
Their anxiety levels were measured using a scale from 0 to 10 (0 = No anxiety, 10 = Extreme anxiety).
Training for the experimental group:
A special 40-50 minute training session was given a day before surgery. The training included breathing techniques, relaxation methods, and information about what to expect during recovery.
Family members were also involved.
After the surgery:
Patients were sedated as part of hospital protocol and then observed when they first woke up in the Intensive Care Unit (ICU).
The trained group received additional therapeutic communication techniques when they first woke up to help them stay calm.
The control group received only standard hospital care. Four hours after waking up, all patients were evaluated for their agitation levels and reactions to intubation.
How Were Reactions Measured? Richmond Agitation Sedation Scale (RASS ) - This measured how restless or calm the patient was.
Observation of Intubation Reactions - The research team noted behaviors such as:
Trying to pull out the breathing tube Biting the tube Facial expressions (like frowning or grimacing) Grabbing bed sheets Moving legs restlessly Breathing in sync with the ventilator Each behavior was scored from 0 (Not observed) to 4 (Strongly observed). A higher score meant the patient was more uncomfortable with intubation.
Results General reactions to intubation (measured with a scale) were similar in both groups.
However, when specific behaviors were examined, the control group had more visible distress:
More frowning and wrinkled facial expressions (p=0.030). More grabbing of bed sheets (p=0.013). There was no significant difference in agitation levels between the two groups. The time taken to remove the breathing tube was also not significantly different between the two groups.
Conclusion The special pre- and post-surgery training helped patients remain more comfortable during intubation, reducing visible signs of distress.
However, the training did not significantly impact overall agitation levels or the time needed to remove the breathing tube.
This suggests that therapeutic communication techniques may improve patient comfort but do not necessarily speed up the recovery process.
Conditions
- Cardiac Surgery Subjects
- Nursing Care
Interventions
- BEHAVIORAL
-
THERAPEUTIC APPROACH TRAINING
This study focuses on pre- and post-operative training for open-heart surgery patients, aiming to reduce anxiety, agitation, and discomfort during intubation and recovery. In the meeting phase, the nurse introduces herself, explains the research, and obtains written/verbal consent. The patient's anxiety level is assessed. In the study phase, patients are informed about the surgical process, breathing exercises, Intensive Care Unit conditions, and postoperative care. They are encouraged to express fears and concerns to improve psychological preparedness. Key topics include: Fasting before surgery Breathing exercises to ease extubation Use of mechanical ventilation Intensive Care Unit environment \& pain management Early mobilization \& recovery timeline Patients receive guidance on their role in recovery, ensuring better adaptation and reduced distress post-surgery.
Sponsors & Collaborators
-
Bezmialem Vakif University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-10
- Primary Completion
- 2023-01-07
- Completion
- 2023-01-07
Countries
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Tele-Nursing Follow-Up After Open Heart Surgery
NCT05316207 ·Status: COMPLETED ·Phase: NA
-
The Effect of Heating on Thermal Comfort and Anxiety
NCT04244071 ·Status: COMPLETED ·Phase: NA
-
Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
NCT03862391 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Web-Based Training With Thyroidectomy Patients
NCT04082845 ·Status: COMPLETED ·Phase: NA
-
Effect of Chest Tube Withdrawal on Patients' Anxiety Levels After Thoracic Surgery
NCT06531928 ·Status: RECRUITING
-
Effects of Improved Environment on Sleep, Anxiety-Depression
NCT06744023 ·Status: COMPLETED ·Phase: NA
-
Waiting Time in the Premedication Room on Anxiety
NCT06477731 ·Status: ACTIVE_NOT_RECRUITING
-
Deep Breathing Exercise With Incentive Spirometer Started in the Preoperative Period
NCT05428722 ·Status: COMPLETED ·Phase: NA
-
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
NCT07327957 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery
NCT05820789 ·Status: COMPLETED ·Phase: NA
-
Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain
NCT05902052 ·Status: COMPLETED ·Phase: NA
-
The Effection Pain and Anxiety of a Breathing Exercise Applied Following Laparoscopic Cholecystectomy
NCT05535491 ·Status: COMPLETED ·Phase: NA
-
Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation
NCT06543134 ·Status: RECRUITING
-
The Chest Physiotherapy and Breathing Exercises Management of Patients Following Open Heart Surgery: a National Survey of Practice in Turkey.
NCT03971396 ·Status: COMPLETED
-
Comparisons of Two Different Type Heater in Different Inhalation Anesthesia in Terms of Prevention of Hypothermia
NCT06107647 ·Status: RECRUITING ·Phase: NA
-
Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal
NCT05032469 ·Status: COMPLETED ·Phase: NA
-
Ultrasound-Based Airway Assessment for Predicting Difficult Intubation in Adult Female Patients
NCT07343557 ·Status: COMPLETED
-
The Effect of Heating the Intensive Care Room in the Early Postoperative Period on Patient Outcomes
NCT07137143 ·Status: RECRUITING ·Phase: NA
-
Pressure Injury Training With a Blended Approach Learning Approach on Care Behaviors of Intensive Care Nurses
NCT05762341 ·Status: COMPLETED ·Phase: NA
-
The Effect of Premedication Type(Pharmalogical and Non Pharmalogical) on Delirium
NCT03426020 ·Status: UNKNOWN ·Phase: PHASE4
-
Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation
NCT06299735 ·Status: COMPLETED ·Phase: NA
-
Early Evaluation After Cardiac Surgery
NCT05932368 ·Status: COMPLETED
-
Effects of Hyperoxia on Open Heart Surgery
NCT03012997 ·Status: UNKNOWN ·Phase: NA
-
The Effect of Rapid Relaxation Exercise and Cold Application on Pain, Anxiety, and Satisfaction Before Chest Tube Removal
NCT07248085 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Effect of Assistive Airway Equipment on Intubation
NCT06596889 ·Status: ACTIVE_NOT_RECRUITING