Pain Diary Use After Laparoscopic Cholecystectomy

NCT07308730 | Recruiting

• 2 other identifiers: 250100Decision No: 102
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis; Postoperative Pain

Keywords

Postoperative Pain; Daily Pain Assessment; Laparoscopic Cholecystectomy; Pain Diary

Outcome Measures

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.

  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

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

Study Arms (2)

Pain Management Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

Pain Management Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Menteşe State Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Pain, Postoperative

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Gülşah K KÖSE

  Muğla Sıtkı Koçman University / Faculty of Health Sciences Department of Nursing

  STUDY DIRECTOR

Central Study Contacts

Muhammed A ASLAN

CONTACT

+905313769110; aslanmuhammed282@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is performed in this study; both participants and researchers are aware of group assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student (MSc) in Surgical Nursing

Model Details: This study uses a parallel design with two groups: an intervention group receiving the pain management protocol and a control group receiving standard care.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 30, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• 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

Locations

TU (1)