Konya Beyhekim Research and training hospital
Konya, 42130, Turkey (Türkiye)
NCT Number: NCT07303634
This study aims to evaluate the effects of teaching the 4-7-8 breathing technique, one of the deep breathing techniques, to patients undergoing laparoscopic cholecystectomy surgery and applying it during the preoperative and postoperative periods on postoperative pain levels, anxiety levels, and sleep quality. Secondary objectives are to evaluate patients' postoperative peripheral oxygen saturation and length of hospital stay.
Patients will be randomized into two groups using a closed opaque envelope technique, and the groups will be determined. This procedure will be performed by a researcher not involved in the study. Patients undergoing Laparoscopic Cholecystectomy will be randomized. The groups will be coded as A and B. Group A patients will be instructed to practice the 4-7-8 breathing technique for 6 hours per day, 10 cycles per hour, during the preoperative and postoperative periods after receiving training. Group B will be the control group, and routine follow-ups will be performed on these patients. Participants' correct and regular application of the breathing technique will be verified through a short test after training and follow-up calls. Participants will be given an "Informed Consent Form," and their consent will also be obtained not to interact with each other or share group information. The perioperative process will be monitored by anesthesiologists not involved in the study.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
Konya, 42130, Turkey (Türkiye)
The study is planned to be conducted at the Anesthesiology and Resuscitation Clinic of Beyhekim Training and Research Hospital with hospital ethics committee approval and informed patient consent. A total of 100 patients aged 18-65 years in ASA I-III groups, 50 patients per group, will undergo laparoscopic cholecystectomy.
Inclusion criteria
for the study
In our clinical practice, 1 mg of midazolam will be administered intravenously as standard premedication to patients admitted to the operating room. Standard monitoring procedures will include electrocardiography (ECG), peripheral oxygen saturation (SpO2), and noninvasive arterial blood pressure measurements during the procedure.
Study Design According to randomization, all patients will receive a standard general anesthesia protocol administered by anesthesiologists with at least 5 years of clinical experience who are blinded to the randomization. These patients will undergo preoxygenation with 2 minutes of 4 L/min mask ventilation in the supine position on the operating table.
During anesthesia induction, 2 mg/kg propofol (Propofol%1-Fresenius®, Fresenius Kabi), 0.6 mg/kg rocuronium (Esmeron), and 1 μg/kg fentanyl (Talinat) were administered. Anesthesia maintenance will be provided with remifentanil 0.1-0.2 μg/kg/min infusion, 40% O2 with 60% air, and sevoflurane (MAC 1-2%) inhalation.
All patients will undergo routine laparoscopic cholecystectomy surgery. The perioperative intravenous analgesic drugs used in both groups were 50 mg dexketoprofen (2 ml ampoule) and 1 gram paracetamol (100 ml vial). All patients will be decubated and extubated by administering 2-4 mg/kg intravenous sugammadex. Patients with a monitored tetrodotoxin response (TOF) >0.9 will be included in the evaluation (Benevision N15, Shenzhen Mindray, China).
Data on the groups will be collected by other anesthesiologists in the postoperative period at 1 hour, 4 hours, 12 hours, and 24 hours, as well as the Hospital Anxiety and Depression Scale (HADS) and the Richard-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1. Data analysis will be performed by a statistician.
Measurements to be Applied in the Study Visual Analog Score (VAS) is one of the most commonly used pain assessment scales in practice. Patients participating in the study will be instructed to report their pain on a scale from 0 (no pain) to 10 (the most severe pain they can describe).
The Hospital Anxiety and Depression Scale was developed to identify anxiety disorders and depression in patients in hospital clinics outside of psychiatry. The HADS is short and easy to score and is widely used in adults. These subscales, each consisting of 7 items, assess both anxiety and depression symptoms with a total of 14 items. Responses are scored on a four-point Likert scale ranging from 0 to 3. Anxiety Score results of 10 or above may indicate Generalized Anxiety Disorder. A Depression Score of 7 or higher may indicate depression.
The Richard-Campbell Sleep Scale, developed by Richards in 1987, is a 6-item measure that assesses the depth of nighttime sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake after waking up, the quality of sleep, and the noise level in the environment. Each item is evaluated on a scale ranging from 0 to 100 using the visual analog scale technique. A score between "0-25" on the scale indicates very poor sleep, while a score between "76-100" indicates very good sleep. The total scale score is evaluated based on 5 items; the 6th item, which assesses the noise level in the environment, is excluded from the total score evaluation. As the scale score increases, patients' sleep quality also improves.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1th, 4th, 12th hours postoperative first day
A 0-10 cm scale is used, and scores are expressed on a scale of 1-10. In this case, 1-3 is generally considered mild, 4-6 moderate, and 7-10 severe.
Time frame: 12th and 24th hours postoperative first day
The Hospital Anxiety and Depression Scale, known as HADS, was developed specifically to screen for mental health status in individuals with physical illnesses. It consists of a total of 14 questions (items).
Seven of these questions measure anxiety (HADS-A), while the other seven measure depression (HADS-D).
Each question is a four-point Likert-type scale scored from 0 to 3. (Maximum 21 points).
0-7 Points: Normal
8-10 Points: Borderline case
11-21 Points: Abnormal (Case)
Time frame: 12th and 24th hours postoperative first day
The Richard-Campbell Sleep Scale (RCSS) is a widely used subjective tool designed to assess the quality and depth of sleep, primarily in hospitalized patients, especially those in critical care units (ICU/CCU). It is typically administered immediately upon waking. The core component of the RCSS is an 100mm Visual Analog Scale (VAS) on which the patient rates the quality of their sleep from 'Worst Sleep Ever' (scored 0) to 'Best Sleep Ever' (scored 100). Higher scores indicate better self-reported sleep quality.
Time frame: 1th, 4th, 12th and 24th hours postoperative first day
Postoperative peripheral oxygen saturation is a vital sign that measures the percentage of hemoglobin in the peripheral arterial blood that is saturated with oxygen after a surgical procedure. It is a critical indicator of the patient's respiratory function and the adequacy of tissue oxygenation in the recovery period.
Time frame: up to seven days
The Length of Hospital Stay (LOS), also known as duration of inpatient stay, is the total number of days a patient remains admitted in a hospital, from the day of admission to the day of discharge. It is a critical metric used in healthcare management, planning, and quality assessment.
Konya Beyhekim Training and Research Hospital
Other Gov
Effects of the 4-7-8 Breathing Technique, One of the Deep Breathing Techniques, on Postoperative Pain Scores, Anxiety, and Sleep Quality in Patients Undergoing Laparoscopic Cholecystectomy
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