Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity and Pain Diary vs. VAS Comparison
研究概览
简要总结
This randomized controlled study aims to evaluate the effectiveness of using a pain diary in the assessment of early postoperative pain in patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to a pain diary group or a control group receiving routine pain assessment. Postoperative pain intensity will be measured at predefined time points using standardized pain assessment tools. The study seeks to improve patient participation in postoperative pain evaluation without introducing additional pharmacological interventions.
详细描述
This is a single-center, randomized controlled trial conducted in patients undergoing elective laparoscopic cholecystectomy. Eligible patients are randomly assigned to either the intervention group or the control group using a block randomization method.
In the intervention group, postoperative pain assessment is performed using a patient-completed pain diary. The pain diary is developed based on the literature and expert opinions and is introduced to patients during the preoperative period. Patients are instructed on how to complete the pain diary, and pain intensity is recorded at rest and during movement at predefined postoperative time points.
In the control group, postoperative pain assessment is carried out using routine clinical practice with the Visual Analog Scale (VAS). Pain assessments are performed at the same postoperative time points as in the intervention group.
Additional pain-related assessments are conducted in both groups during the postoperative period. To minimize contamination between groups, patients in the intervention and control groups are followed in separate hospital rooms. Due to the visible nature of the pain diary, blinding is not feasible in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking is performed in this study; both participants and researchers are aware of group assignments.
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
- •Admitted for elective laparoscopic cholecystectomy
- •Scheduled for first-time laparoscopic cholecystectomy
- •Aged 18 years or older
- •Able to speak, read, and understand Turkish
- •Communicative and cooperative
- •ASA score of 1, 2, or 3
- •Expected to stay at least 24 hours in the hospital post-surgery
- •Capable of understanding study instructions
- •Willing to participate voluntarily
排除标准
- •Prolonged stay in the recovery unit due to extended effects of general anesthesia
- •Admission to intensive care unit postoperatively
- •Having chronic pain and receiving treatment for it
- •Being a cancer patient
- •Having a writing disability
- •Inability to communicate
- •Having cognitive, affective, verbal, visual, or auditory impairments
- •Diagnosed psychiatric disorders such as anxiety or depression and using related medications
- •Choosing to withdraw from the study after giving consent
研究组 & 干预措施
Pain Management Intervention Group
Participants in this group will follow the pain management protocol after laparoscopic cholecystectomy, including recording postoperative pain in a pain diary.
干预措施: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy (Behavioral)
Control Group
Participants in this group will receive standard care after laparoscopic cholecystectomy. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at scheduled times by nurses and researchers, and recorded accordingly
结局指标
主要结局
Postoperative Pain Intensity and Pain Diary vs. VAS Comparison
时间窗: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)
The primary outcome measure involves postoperative pain intensity recorded by patients in the intervention group using a daily pain diary, compared to routine clinical VAS measurements in the control group. Measurements will be taken at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours post-surgery. Additionally, short pain inventories at 24 and 48 hours and VAS-based satisfaction evaluation before discharge will be performed.
次要结局
- Postoperative Pain Intensity(During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively))
研究者
MUHAMMED ASLAN
Graduate Student (MSc) in Surgical Nursing
Muğla Sıtkı Koçman University