Gedik University
Istanbul, Kartal, Turkey (Türkiye)
NCT Number: NCT06881212
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.
Looking for future studies?
Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Istanbul, Kartal, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
The demographic characteristics of the patients such as age, gender, education level, chronic diseases, history of surgery, height and weight, smoking and alcohol use, psychiatric treatment and follow-up status were evaluated with a 13-item form created by the researchers by using the literature.
Time frame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
The Numerical Anxiety scale has a starting point of "0" or "no anxiety" and an ending point of '10' or "severe anxiety" (horizontal line was used in this study). The patient chooses the number from the scale that best describes him/her. Preoperative and postoperative anxiety is higher in patients undergoing open heart surgery compared to other surgeries. Anxiety level is a factor that may lead to increased agitation and patient non-compliance with mechanical ventilator. For this reason, anxiety level was used as a control variable to measure the effectiveness of the intervention to be applied to the experimental and control groups and to ensure the homogeneity of the experimental and control groups. The results of the scale were evaluated on the arithmetic mean.
Time frame: Within 12 weeks after the initial registration date,after the operation
The scale was developed by the Virginia Commonwealth University of Richmond. In the scale, which has a total score of 10, the patient's agitation is scored in the reference range of +4 (combative; potentially dangerous for staff) to -5 (cannot be aroused). Scoring is done as; +4 belligerent, +3 very agitated, +2 agitated, +1 restless, 0 calm/awake, -1 sleepy, -2 light sedation, -3 moderate sedation, -4 deep sedation and -5 coma. A positive score indicates that the patient is agitated and a negative score indicates that the patient is in a coma or under the influence of sedation .Written permission for the scale was obtained via e-mail.
Time frame: Within 12 weeks after the initial registration date after the operation
In this observation form, 6 of the most common behaviors (Trying to pull the intubation tube, biting the intubation tube, wrinkled facial expression, collecting sheets with hands, trying to take the legs out of the bed railing, showing compliance with the ventilator) were examined by examining the literature and taking into account the changes indicated by 8 experts in the field according to the opinion form. In the form consisting of 6 sections, each item is graded on a 5-point Likert-type scale. (0=Behavior Not Observed; 4=Sustained Observed) The intubation behaviors observation form score is obtained by summing the scores of the questions. A high score indicates poor compliance with intubation. The Cronbach's alpha value of this scale was determined as 0.824 for this study.Intubation length of stay was recorded.
Bezmialem Vakif University
Other
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