Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- NRS (numeric rating scale)
研究概览
简要总结
This research was designed as a randomized controlled trial to determine the effects of coffee sniffing on pain and physiological parameters in patients undergoing cholecystectomy surgery.
详细描述
Study Variables: The independent variables of the study are the participant's age, gender, height, weight, smoking, and alcohol use; the dependent variables are the length of stay in the Post-anesthesia care unit (PACU) after anesthesia, the Modified Aldrete score, the pain score (numeric rating scale), and physiological values.
Study Location and Time: This study is planned to be conducted at Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital PACU, between February 2026 and August 2026.
Study Population: The study population will consist of patients who underwent cholecystectomy surgery and received general anesthesia with the same anesthesia protocol at Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital PACU.
Data Collection Tools: A Patient Demographic Information Form, created by the researcher in accordance with the literature, will be used for data collection. The Modified Aldrete Score and the Visual Analog Scale, both valid and reliable, will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older,
- •Having no prior history of surgery,
- •Having undergone laparoscopic cholecystectomy surgery,
- •Being physically and mentally able to communicate,
- •Having received the same anesthesia protocol,
- •Having no known allergy or sensitivity to the smell of coffee,
- •Being willing and cooperative to smell coffee for the specified duration in the experimental group,
- •Providing written consent after being informed about the study,
- •Having an ASA I or II rating.
排除标准
- •The following are contraindications for a patient's sense of smell:
- •No complications developing during surgery,
- •No indication for postoperative intensive care,
- •Special circumstances (pregnancy, etc.),
- •Being under active treatment for depression, anxiety, or other psychiatric disorders,
- •Having anatomical abnormalities that may cause a problem with the sense of smell.
研究组 & 干预措施
Coffee Smelling Group
The patient inhales the scent of coffee for 3-5 minutes using a cotton pad.
干预措施: Coffee Smell (Behavioral)
Placebo Group
The patient inhales an empty cotton bag for 3-5 minutes.
干预措施: Placebo (Behavioral)
结局指标
主要结局
NRS (numeric rating scale)
时间窗: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
The Numeric Rating Scale (NRS) is a simple, closed-ended survey tool that asks respondents to assign a number to measure feelings, preferences, or symptoms. It is widely used across healthcare, market research, and customer service to translate subjective experiences into quantifiable, easy-to-analyze data. 0-10 Scale (Pain Management): The most common format. In clinical settings, the Numeric Pain Rating Scale (NPRS) asks patients to rate pain from 0 ("no pain") to 10 ("worst possible pain").
Modified Aldrete Score
时间窗: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
The Modified Aldrete Score is a clinical scoring system used to assess a patient's recovery and readiness for discharge from the post-anesthesia care unit (PACU) based on activity, respiration, circulation, consciousness, and oxygen saturation. Ensures objective and standardized assessment of postoperative recovery Reduces risk of premature discharge from PACU Enhances patient safety by identifying respiratory, cardiovascular, or neurological instability Provides measurable criteria for clinical decision-making Commonly, a score of ≥ 9 indicates readiness for PACU discharge.
VAS
时间窗: This is the period from post-operative time until discharge from the PACU unit. (min. 20/min- max 60/min).
The Visual Analog Scale (VAS) for pain is a simple tool used to measure a patient's pain intensity. It usually consists of a 10-centimeter horizontal line with one end labeled "no pain" and the other end labeled "worst pain imaginable." The patient marks a point on the line that represents their level of pain, and the distance from the "no pain" end is measured to determine a numerical score. VAS is widely used in clinical practice and research because it provides a quick, subjective, and reliable assessment of pain severity.
次要结局
未报告次要终点
研究者
Emre Kugu
PhD. Student
Istanbul University - Cerrahpasa