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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- visual analog scale
研究概览
简要总结
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.
详细描述
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
- Participants must be informed and give voluntary consent to participate in the study.
- Patients who have undergone laparoscopic cholecystectomy.
- Patients with an ASA physical performance score of 1-3.
- Patients aged 18-65 years. Exclusion criteria
1) Patients who do not wish to continue participating in the study 2) Deterioration in the medical condition of patients. 3) Those with a history of medication use accompanied by depression and other psychiatric diagnoses 4) Those with a history of substance abuse 5) Those with respiratory tract infection or pathology (Asthma, COPD) 6) Patients with neuromuscular disorders 7) Patients under 18 years of age 8) Patients who cannot read or write Turkish or who are uncooperative 9) Patients unable to comply with breathing training techniques 10) Conversion from laparoscopic to open surgery Preoperative procedures Patients who receive breathing technique training prior to surgery will be asked to practice the 4-7-8 breathing technique for 6 hours, 10 cycles per hour, the day before surgery. In this technique, patients sit with their backs straight and place the tip of their tongue behind their upper front teeth. They count to four while taking a deep breath through their nose, then hold their breath while counting to seven, and finally exhale slowly through their mouth while counting to eight, preferably accompanied by a slight humming sound. The cycle is repeated three more times for a total of four breaths.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be informed and give voluntary consent to participate in the study.
- •Patients who have undergone laparoscopic cholecystectomy.
- •Patients with an ASA physical performance score of 1-
- •Patients aged 18-65 years.
排除标准
- •Patients who do not wish to continue participating in the study
- •Patients whose medical condition has deteriorated.
- •Those with a history of medication use accompanied by depression and other psychiatric diagnoses
- •Those with a history of substance dependence
- •Those with respiratory tract infection or pathology (Asthma, COPD)
- •Those with neuromuscular disorders
- •Those under the age of 18
- •Patients who cannot read or write Turkish or who are uncooperative
- •Those unable to adapt to breathing training techniques
- •Conversion from laparoscopic surgery to laparotomy
结局指标
主要结局
visual analog scale
时间窗: 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.
Hospital Anxiety and Depression Scale
时间窗: 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)
Richard-Campbell Sleep Scale
时间窗: 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.
次要结局
- peripheral oxygen saturation(1th, 4th, 12th and 24th hours postoperative first day)
- length of hospital stay(up to seven days)
研究者
Sami Uyar
Dr.
Konya Beyhekim Training and Research Hospital