Pain ScoreLumpectomyNCT06928064
Pain Sensitivity Questionnaire Applied in Preoperative Period in Lumpectomy
An observational study of Pain Score and Pain Postoperative, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Pain Score, Pain Postoperative
- What is being tested?
- Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy).
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 23 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-70 who are scheduled for breast-conserving surgery
Who may be able to join
- Having planned BCS with general anesthesia
- Being a female patient between the ages of 18-70
- Being evaluated as American Society of Anesthesiologists (ASA) I, II, III
- Having given written consent to participate in the study
Who cannot join
- Pregnancy
- Being assessed as ASA IV
- Having advanced cardiac, pulmonary and cerebrovascular disease, advanced renal failure, liver failure, history of fentanyl/remifentanyl hypersensitivity, Alzheimer's disease, mental retardation
- Being at a mental level that cannot comply with the evaluations within the scope of the study
- Not having given written consent for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy)
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.
Read the detailed description
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.
Materials and Methods: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.
The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating Scale (NRS).
- Conditions
- Pain Score, Pain Postoperative
- Being tested
- Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy).
- Keywords
- breast surgery, pain sensivity
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy).Procedure or surgery
: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.
The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating
| Study group | Role | What they receive |
|---|---|---|
| Having planned BCS with general anesthesia • Being a female patient between the ages of 18-70 | Having planned BCS with general anesthesia Being a female patient between the ages of 18-70 Being evaluated as American Society of Anesthesiologists (ASA) I, II, III Having given written consent to participate in the study Receives: Procedure: Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Lumpectomy
This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.The aim was to examine the relationship between the PSQ score measured in the preoperative period and the degree of pain in the postoperative period. BPI score and NRS score were used in the evaluation of postoperative pain.
Measured: From March 2024 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Mar 2024
- Primary completion31 Aug 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ScoreStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SEVDE RUMEYSA YILMAZ, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- BANU CEVIK, PROFFESSOR, Study chair, DR LUTFI KIRDAR CITY HOSPİTAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928064
- Sponsor's protocol ID
- SRYILMAZ
- Other IDs
- 010.99/16
- Acronym
- Lumpectomy
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy)
- ClinicalTrials.gov ID
- NCT06928064
- Acronym / sponsor ID
- Lumpectomy / SRYILMAZ
- Conditions
- Pain Score, Pain Postoperative
- Keywords
- breast surgery, pain sensivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 15 Apr 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.
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.
Detailed description
Objective: The Pain Sensitivity Questionnaire (PSQ) is a clinically valuable tool that has been shown to correlate with various experimental pain sensitivity assessments in healthy individuals and patients with chronic pain. In this study, we aimed to investigate the effectiveness of the PSQ in predicting postoperative pain in patients undergoing breast-conserving surgery.
Materials and Methods: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.
The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating Scale (NRS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Having planned BCS with general anesthesia • Being a female patient between the ages of 18-70 | – | Procedure: Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy).Having planned BCS with general anesthesia Being a female patient between the ages of 18-70 Being evaluated as American Society of Anesthesiologists (ASA) I, II, III Having given written consent to participate in the study |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-70 who are scheduled for breast-conserving surgery
Key inclusion criteria (4 listed)
- Having planned BCS with general anesthesia
- Being a female patient between the ages of 18-70
- Being evaluated as American Society of Anesthesiologists (ASA) I, II, III
- Having given written consent to participate in the study
Key exclusion criteria (5 listed)
- Pregnancy
- Being assessed as ASA IV
- Having advanced cardiac, pulmonary and cerebrovascular disease, advanced renal failure, liver failure, history of fentanyl/remifentanyl hypersensitivity, Alzheimer's disease, mental retardation
- Being at a mental level that cannot comply with the evaluations within the scope of the study
- Not having given written consent for any reason
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 |
|---|---|---|
| Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Breast-Conserving Surgery (Lumpectomy).: This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up. The PSQ was administered to all patients during the preoperative period to assess their pain sensitivity. Anesthesia induction and maintenance followed a standardized protocol on the day of surgery. The intraoperative analgesic consumption and the duration of the surgery were documented. Postoperative assessments were conducted 24 hours after the surgery in the general surgery ward, where analgesic use and short pain inventory scores were recorded. Patients were followed up one month postoperatively, and their pain levels were assessed using the Numeric Rating | Procedure or surgery | Having planned BCS with general anesthesia • Being a female patient between the ages of 18-70 |
Primary outcome
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Lumpectomy
Time frame: From March 2024 to August 2024
This study included 74 patients over the age of 18 with American Society of Anesthesiologists (ASA) scores of I, II, or III, who were scheduled to undergo breast-conserving surgery. Ethical approval from the local ethics committee and written informed consent from each patient were obtained. Patient data, including age, ASA score, and comorbidities, were collected, and contact details were recorded for postoperative follow-up.The aim was to examine the relationship between the PSQ score measured in the preoperative period and the degree of pain in the postoperative period. BPI score and NRS score were used in the evaluation of postoperative pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
BANU CEVIK, PROFFESSOR study chair
DR LUTFI KIRDAR CITY HOSPİTAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Score and Pain Postoperative, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Postoperative Pain Severity Using Pain Sensitivity Questionnaire Applied in Preoperative Period in Patients Undergoing Lumpectomy (time frame: From March 2024 to August 2024). 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 15 Apr 2025.