Cholelithiasis, Postoperative Pain
Conditions
Keywords
Postoperative Pain, Daily Pain Assessment, Laparoscopic Cholecystectomy, Pain Diary
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPostoperative Pain Management Protocol for Laparoscopic Cholecystectomy
This pain management protocol is specifically tailored for patients undergoing laparoscopic cholecystectomy and combines both scheduled pharmacological analgesics and non-pharmacological pain control measures. Unlike other studies, it includes daily pain diary monitoring to objectively track patient-reported postoperative pain and recovery outcomes.
Sponsors
Muğla Sıtkı Koçman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
No masking is performed in this study; both participants and researchers are aware of group assignments.
Intervention model description
This study uses a parallel design with two groups: an intervention group receiving the pain management protocol and a control group receiving standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted for elective laparoscopic cholecystectomy 2. Scheduled for first-time laparoscopic cholecystectomy 3. Aged 18 years or older 4. Able to speak, read, and understand Turkish 5. Literate 6. Communicative and cooperative 7. ASA score of 1, 2, or 3 8. Expected to stay at least 24 hours in the hospital post-surgery 9. Capable of understanding study instructions 10. Willing to participate voluntarily
Exclusion criteria
1. Prolonged stay in the recovery unit due to extended effects of general anesthesia 2. Admission to intensive care unit postoperatively 3. Having chronic pain and receiving treatment for it 4. Being a cancer patient 5. Having a writing disability 6. Inability to communicate 7. Having cognitive, affective, verbal, visual, or auditory impairments 8. Diagnosed psychiatric disorders such as anxiety or depression and using related medications 9. Choosing to withdraw from the study after giving consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity and Pain Diary vs. VAS Comparison | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively) | Postoperative pain intensity will be assessed using a 0-10 Likert scale (VAS). In the intervention group, patients will record their pain in a daily pain diary at scheduled times, while in the control group, routine clinical VAS measurements will be performed. Additionally, short pain inventories at 24 and 48 hours and VAS-based satisfaction evaluation before discharge will be conducted |
Countries
Turkey (Türkiye)
Contacts
Primary ContactMuhammed A ASLAN
Outcome results
None listed