Keeping a pain diary after laparoscopic gallbladder removal
Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy
This project will see if asking adults having elective laparoscopic gallbladder removal to keep a short pain diary helps track their early postoperative pain better than routine checks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Muğla Sıtkı Koçman University Academic / other |
| Locations | 1 site (Muğla, Menteşe) |
| Trial ID | NCT07308730 on ClinicalTrials.gov |
What this trial studies
This single-center randomized controlled trial enrolls adults scheduled for first-time elective laparoscopic cholecystectomy and assigns them by block randomization to either a patient-completed pain diary or routine clinical pain assessment using the Visual Analog Scale. Patients in the diary group receive instruction before surgery and record pain at rest and during movement at predefined postoperative time points; both groups have additional standardized pain-related assessments. Participants are cared for in separate rooms to reduce cross-contamination, and blinding is not possible because the diary is visible. The protocol does not introduce new drugs and focuses on patient participation and measurement of early postoperative pain.
Who should consider this trial
Good fit: Adults (18+) scheduled for first-time elective laparoscopic cholecystectomy who are literate, speak and read Turkish, are communicative and cooperative, have ASA 1–3, and are expected to stay at least 24 hours postoperatively.
Not a fit: Patients with chronic pain under treatment, cognitive or communication impairments, psychiatric disorders on related medications, ICU admission, prolonged recovery-unit stays, or a writing disability are unlikely to benefit from the diary intervention.
Why it matters
Potential benefit: If successful, the pain diary could give patients a clearer way to report pain that improves the consistency of pain records and communication with care teams.
How similar studies have performed: Similar patient-completed pain diaries have been used in other postoperative settings with mixed results, with some studies showing improved patient reporting and engagement but variable effects on clinical pain outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Muğla, Menteşe
- Menteşe State Hospital — Muğla, Menteşe, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Muhammed A ASLAN
- Email: aslanmuhammed282@gmail.com
- Phone: +905313769110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.