Pain Diary Use After Laparoscopic Cholecystectomy

NCT ID: NCT07308730

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2027-01-30

Brief Summary

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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

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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.

Conditions

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Cholelithiasis Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

No masking is performed in this study; both participants and researchers are aware of group assignments.

Study Groups

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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.

Group Type EXPERIMENTAL

Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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MUHAMMED ASLAN

Graduate Student (MSc) in Surgical Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah K KÖSE

Role: STUDY_DIRECTOR

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

Locations

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Menteşe State Hospital

Muğla, Menteşe, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Muhammed A ASLAN

Role: CONTACT

+905313769110

Facility Contacts

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Şadi B BALLI

Role: primary

+90 252 213 10 24

Elif A Akkaya

Role: backup

+90 252 213 10 25

Other Identifiers

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Decision No: 102

Identifier Type: OTHER

Identifier Source: secondary_id

250100

Identifier Type: -

Identifier Source: org_study_id

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