Pain Diary Use After Laparoscopic Cholecystectomy (PDP-LC)

Muğla Sıtkı Koçman University

Status: Enrolling

Conditions: Postoperative Pain; Cholelithiasis

Treatments: Behavioral: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07308730

250100

Decision No: 102 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Pain Management Intervention Group

Experimental group

Description:

Participants in this group will follow the pain management protocol after laparoscopic cholecystectomy, including recording postoperative pain in a pain diary.

Treatment:

Behavioral: Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy

Control Group

No Intervention group

Description:

Participants in this group will receive standard care after laparoscopic cholecystectomy. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at scheduled times by nurses and researchers, and recorded accordingly