Study Results
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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RECRUITING
NA
142 participants
INTERVENTIONAL
2025-11-15
2027-01-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
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.
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.
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Muğla Sıtkı Koçman University
OTHER
Responsible Party
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MUHAMMED ASLAN
Graduate Student (MSc) in Surgical Nursing
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)
Countries
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Central Contacts
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Facility Contacts
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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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