Keeping a pain diary after laparoscopic gallbladder removal
Official title: Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy
Run by Muğla Sıtkı Koçman University · NCT07308730 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 142 (estimated) |
| Sponsor | Muğla Sıtkı Koçman University Academic / other |
| Locations | 1 site (Muğla, Menteşe) |
| Status | Recruiting |
| Started | November 15, 2025 |
| Main results expected | July 30, 2026 |
| Study ends | January 30, 2027 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT07308730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Menteşe State Hospital
Muğla, Menteşe, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Muhammed A ASLAN
- Email: aslanmuhammed282@gmail.com
- Phone: +905313769110
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.