CholelithiasisPDP-LCNCT07308730
Pain Diary Use After Laparoscopic Cholecystectomy
A study testing Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy in people with Cholelithiasis and Postoperative Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis, Postoperative Pain
- What is being tested?
- Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Menteşe State Hospital
Muğla, Menteşe, 48000
Şadi B BALLI, +90 252 213 10 24, mugla.mentesedh@saglik.gov.tr
Elif A Akkaya, +90 252 213 10 25, mugla.mentesedh@saglik.gov.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Cholelithiasis, Postoperative Pain
- Being tested
- Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy
- Keywords
- Postoperative Pain, Daily Pain Assessment, Laparoscopic Cholecystectomy, Pain Diary
- Medical subject headings
- Cholelithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Pain Management Protocol for Laparoscopic CholecystectomyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: During the first 48 hours post-surgery (measurements at 2, 4, 6, 12, 16, 20, 24, 32, and 48 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start15 Nov 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel design with two groups: an intervention group receiving the pain management protocol and a control group receiving standard care.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUHAMMED ASLAN, Muğla Sıtkı Koçman University
- Investigators
- Gülşah K KÖSE, Study director, Muğla Sıtkı Koçman University / Faculty of Health Sciences Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308730
- Sponsor's protocol ID
- 250100
- Other IDs
- Decision No: 102
- Acronym
- PDP-LC
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Use of Pain Diary in Assessing Early Postoperative Pain Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07308730
- Acronym / sponsor ID
- PDP-LC / 250100
- Conditions
- Cholelithiasis, Postoperative Pain
- Keywords
- Postoperative Pain, Daily Pain Assessment, Laparoscopic Cholecystectomy, Pain Diary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel design with two groups: an intervention group receiving the pain management protocol and a control group receiving standard care.
| Arm | Type | Receives |
|---|---|---|
| Pain Management Intervention Group | Experimental | Behavioral: Postoperative Pain Management Protocol for Laparoscopic CholecystectomyParticipants in this group will follow the pain management protocol after laparoscopic cholecystectomy, including recording postoperative pain in a pain diary. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admitted for elective laparoscopic cholecystectomy
- Scheduled for first-time laparoscopic cholecystectomy
- Aged 18 years or older
- Able to speak, read, and understand Turkish
- Literate
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Pain Management Protocol for Laparoscopic CholecystectomyThis 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. | Behavioural | Pain Management Intervention Group |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gülşah K KÖSE study director
Muğla Sıtkı Koçman University / Faculty of Health Sciences Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Pain Management Protocol for Laparoscopic Cholecystectomy in people with Cholelithiasis and Postoperative Pain, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed A ASLAN (+905313769110, aslanmuhammed282@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.