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| ID | Type | Description | Link |
|---|---|---|---|
| Decision No: 102 | Other Identifier | Muğla Sıtkı Koçman University Healt Sciences Ethic Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammed A ASLAN | Contact | +905313769110 | aslanmuhammed282@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gülşah K KÖSE | Muğla Sıtkı Koçman University / Faculty of Health Sciences Department of Nursing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menteşe State Hospital | Recruiting | Muğla | Menteşe | 48000 | Turkey (Türkiye) |
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
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
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
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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This study uses a parallel design with two groups: an intervention group receiving the pain management protocol and a control group receiving standard care.
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No masking is performed in this study; both participants and researchers are aware of group assignments.
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| During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively) |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |