Pain Diary Use After Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMuğla Sıtkı Koçman University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted for elective laparoscopic cholecystectomy

Scheduled for first-time laparoscopic cholecystectomy

Aged 18 years or older

Able to speak, read, and understand Turkish

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy

    Behavioral

    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.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: Pain Management Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity and Pain Diary vs. VAS Comparison

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.

Time frame
During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)

Secondary outcomes

1

Postoperative Pain Intensity

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

Time frame
During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.