Pain Diary Use After Laparoscopic Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy.
- Who it may be relevant to
- Registry conditions: Cholelithiasis, Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy
Overview
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
- Behavioral Postoperative 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.
Primary outcome measures
- Postoperative Pain Intensity and Pain Diary vs. VAS Comparison [Time frame: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)]
Secondary outcome measures (1)
- Postoperative Pain Intensity [Time frame: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)]
Eligibility criteria
Inclusion criteria
- Admitted for elective laparoscopic cholecystectomy
- Scheduled for first-time laparoscopic cholecystectomy
- Aged 18 years or older
- Able to speak, read, and understand Turkish
- Literate
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Turkey (Türkiye) · 1 center
- Menteşe State Hospital — Muğla
Identifiers
NCT: NCT07308730 · 250100 · Decision No: 102