Pain Diary Use After Laparoscopic Cholecystectomy (PDP-LC)

December 31, 2025 updated by: MUHAMMED ASLAN, Muğla Sıtkı Koçman University

Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Management Intervention Group
Participants in this group will follow the pain management protocol after laparoscopic cholecystectomy, including recording postoperative pain in a pain diary.
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.
No Intervention: Control Group
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Study Director: Gülşah K KÖSE, Muğla Sıtkı Koçman University / Faculty of Health Sciences Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Estimated)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250100
  • Decision No: 102 (Other Identifier: Muğla Sıtkı Koçman University Healt Sciences Ethic Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The specific individual patient data collected in this study include patient first and last names, signed informed consent forms, socio-demographic information (age, gender, etc.), medical history, and postoperative pain diary data. These data will be used solely for research purposes and shared in accordance with confidentiality principles

IPD Sharing Time Frame

Individual patient data and supporting information will be accessible from the date patients provide informed consent prior to surgery, throughout the data collection period, and for at least 5 years following study completion, stored in accordance with confidentiality principles

IPD Sharing Access Criteria

Individual patient data and supporting information will be accessible only to the study research team. The research team will have access to patient names, surnames, socio-demographic information, medical history, and pain diary data via a secure, password-protected electronic database. The data will be used solely for study purposes and will not be shared with third parties

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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