Clinical trial NCT06881212: Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
Official title: Effects Of Therapeutic Approaches On Intubation Response, Agitation Behavior, And Extubation Time İn Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery Subjects
Nursing Care
Keywords: Education,
Nursing
Cardiovascular Surgery
Therapeutic Approach
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a quasi-experimental study with a post-test experimental-control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Coronary Artery Bypass Graft, Aortic Valve Replacement, Mitral Valve Replacement having undergone one of these operations
* No Chronic Respiratory Disease

Exclusion Criteria:

* Aortic Valve Replacement and Mitral Valve Replacement performed together
* Use of a method other than median sternotomy
* Redo coronary bypass surgery
* Illiteracy and not knowing Turkish
* Being under psychiatric treatment and follow-up recently (last 1 year)

Primary outcomes:
measure: Sociodemographic information form
timeFrame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
measure: Numerical anxiety scale
timeFrame: From the data obtained from the enrollment of the first participant until week 12 Before the operation
Secondary outcomes:
Other outcomes:
measure: Richmond Agitation Sedation Scale (RASS)
timeFrame: Within 12 weeks after the initial registration date,after the operation
measure: Intubation responses observation form
timeFrame: Within 12 weeks after the initial registration date after the operation
Locations:
city: Istanbul
country: Turkey
facility: Gedik University
state: Kartal
Study officials:
References:
citation: Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.
citation: Hoyer J, Eifert GH, Einsle F, Zimmermann K, Krauss S, Knaut M, Matschke K, Kollner V. Heart-focused anxiety before and after cardiac surgery. J Psychosom Res. 2008 Mar;64(3):291-7. doi: 10.1016/j.jpsychores.2007.09.009.
citation: İnce, F. (2020). Kardiyak cerrahi öncesi uygulanan eğitimin anksiyete, depresyon, yaşam kalitesi ve kinezyofobi üzerine etkisi (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).