Postoperative PainNCT07892924
The Effect of Sleep Quality Before Breast Surgery on Postoperative Pain
An observational study of Postoperative Pain and Preoperative Sleep Quality, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the relationship between preoperative sleep quality and postoperative pain in patients undergoing mastectomy or breast-conserving surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Pain, Preoperative Sleep Quality
- What is being tested?
- Sleep Quality and Postoperative Pain Assessment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 23 Feb 2026
- 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: The study population consisted of female patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia at Prof. Dr. Cemil Taşcıoğlu City Hospital in Istanbul, Türkiye. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good and poor sleep quality groups based on their PSQI scores. Postoperative pain intensity, anxiety, depression, pain catastrophizing, and mental health-related quality of life were evaluated at predefined postoperative time points.
Who may be able to join
- Female patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients scheduled to undergo mastectomy or breast-conserving surgery under general anesthesia.
- Modified Aldrete score greater than 8 in the postoperative recovery period.
Who cannot join
- History of alcohol and/or substance abuse.
- Diagnosis of obstructive sleep apnea.
- History of pre-existing sleep disorders or use of additional sleep medications.
- Dementia or mild cognitive impairment.
- History of drug abuse, hepat renal dysfunction, psychosis, or neuropathy.
- Severe hearing impairment or inability to understand or complete the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
- Communication barriers preventing adequate interaction with the anesthesiologist
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr Cemil Tascıoglu City Hospital
Istanbul, Istanbul, 34384
About this study
Official title: The Effect of Preoperative Sleep Quality on Postoperative Pain in Patients Undergoing Mastectomy or Breast-Conserving Surgery
This study aimed to investigate the relationship between preoperative sleep quality and postoperative pain in patients undergoing mastectomy or breast-conserving surgery under general anesthesia.
This prospective observational study included 146 patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-II. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain was evaluated using the Numeric Rating Scale (NRS), including assessments during the early postoperative period and at the three-month follow-up.
The study aimed to determine whether poor sleep quality before surgery was associated with greater postoperative pain. No additional medical interventions were performed as part of the research, and all patients received routine clinical care.
Read the detailed description
This prospective observational study was conducted at the University of Health Sciences, Prof. Dr. Cemil Tascioglu City Hospital, Department of Anesthesiology and Reanimation, following approval by the Clinical Research Ethics Committee on June 17, 2025.
The study included 146 patients aged 18-70 years, classified as ASA physical status I-II, who underwent mastectomy or breast-conserving surgery under general anesthesia.
Eligible patients were informed about the study during the preoperative period, and written informed consent was obtained before participation.
Preoperative sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), with measurements during the early postoperative period and follow-up assessments extending to three months after surgery.
The primary objective was to investigate the association between preoperative sleep quality and postoperative pain intensity. The study also aimed to evaluate the potential clinical importance of identifying patients with poor preoperative sleep quality.
No study-specific therapeutic interventions were administered. All anesthetic, surgical, and postoperative management procedures were performed according to routine clinical practice
- Conditions
- Postoperative Pain, Preoperative Sleep Quality
- Being tested
- Sleep Quality and Postoperative Pain Assessment
- Keywords
- Pittsburgh Sleep Quality Index, Breast Surgery, Mastectomy, Breast-Conserving Surgery, Numeric Rating Scale, Postoperative Pain, Sleep Quality, Chronic Postsurgical Pain
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Quality and Postoperative Pain AssessmentOther
Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were classified as having good sleep quality (PSQI ≤ 5) or poor sleep quality (PSQI > 5). Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS) at predefined postoperative time points, including a three-month follow-up. No experimental therapeutic intervention was administered, and all perioperative care followed routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Breast Surgery Patients | This cohort included 146 patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good sleep quality (PSQI ≤ 5) and poor sleep quality (PSQI > 5) groups for comparative analysis of postoperative pain outcomes. No study-specific therapeutic intervention was administered. Receives: Other: Sleep Quality and Postoperative Pain Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)
Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were recorded at 1, 6, 12, and 24 hours, as well as 3 weeks and 3 months after surgery. NRS scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
Measured: 1, 6, 12, and 24 hours; 3 weeks; and 3 months postoperatively
Secondary outcomes (4)
Pain Catastrophizing Assessed by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire with a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. PCS scores were compared between patients with good and poor preoperative sleep quality.
Measured: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Anxiety Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Anxiety symptoms were assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale consists of 7 items, with scores ranging from 0 to 21. Higher scores indicate greater anxiety symptoms. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. Scores were compared between patients with good and poor preoperative sleep quality.
Measured: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Depression Assessed by the Hospital Anxiety and Depression Scale (HADS-D)
Depressive symptoms were assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater depressive symptoms. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. HADS-D scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
Measured: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Mental Health-Related Quality of Life Assessed by SF-12 Mental Component Summary (MCS)
Mental health-related quality of life was assessed using the Mental Component Summary (MCS) score of the 12-item Short Form Health Survey (SF-12). Higher MCS scores indicate better mental health-related quality of life. Assessments were performed within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery. SF-12 MCS scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
Measured: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start23 Jun 2025
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Bilen, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Ayşegül Bilen, MD, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892924
- Sponsor's protocol ID
- E-48670771-514.99-279156331
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient confidentiality and data privacy considerations. Study findings will be reported in an aggregated and anonymized format.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Sleep Quality on Postoperative Pain in Patients Undergoing Mastectomy or Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07892924
- Acronym / sponsor ID
- E-48670771-514.99-279156331
- Conditions
- Postoperative Pain, Preoperative Sleep Quality
- Keywords
- Pittsburgh Sleep Quality Index, Breast Surgery, Mastectomy, Breast-Conserving Surgery, Numeric Rating Scale, Postoperative Pain, Sleep Quality, Chronic Postsurgical Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 23 Oct 2026 (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 study aimed to investigate the relationship between preoperative sleep quality and postoperative pain in patients undergoing mastectomy or breast-conserving surgery under general anesthesia.
This prospective observational study included 146 patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-II. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain was evaluated using the Numeric Rating Scale (NRS), including assessments during the early postoperative period and at the three-month follow-up.
The study aimed to determine whether poor sleep quality before surgery was associated with greater postoperative pain. No additional medical interventions were performed as part of the research, and all patients received routine clinical care.
Detailed description
This prospective observational study was conducted at the University of Health Sciences, Prof. Dr. Cemil Tascioglu City Hospital, Department of Anesthesiology and Reanimation, following approval by the Clinical Research Ethics Committee on June 17, 2025.
The study included 146 patients aged 18-70 years, classified as ASA physical status I-II, who underwent mastectomy or breast-conserving surgery under general anesthesia.
Eligible patients were informed about the study during the preoperative period, and written informed consent was obtained before participation.
Preoperative sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), with measurements during the early postoperative period and follow-up assessments extending to three months after surgery.
The primary objective was to investigate the association between preoperative sleep quality and postoperative pain intensity. The study also aimed to evaluate the potential clinical importance of identifying patients with poor preoperative sleep quality.
No study-specific therapeutic interventions were administered. All anesthetic, surgical, and postoperative management procedures were performed according to routine clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Surgery Patients | – | Other: Sleep Quality and Postoperative Pain AssessmentThis cohort included 146 patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good sleep quality (PSQI ≤ 5) and poor sleep quality (PSQI > 5) groups for comparative analysis of postoperative pain outcomes. No study-specific therapeutic intervention was administered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of female patients aged 18-70 years with ASA physical status I-II who underwent mastectomy or breast-conserving surgery under general anesthesia at Prof. Dr. Cemil Taşcıoğlu City Hospital in Istanbul, Türkiye. Preoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were subsequently classified into good and poor sleep quality groups based on their PSQI scores. Postoperative pain intensity, anxiety, depression, pain catastrophizing, and mental health-related quality of life were evaluated at predefined postoperative time points.
Key inclusion criteria (4 listed)
- Female patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients scheduled to undergo mastectomy or breast-conserving surgery under general anesthesia.
- Modified Aldrete score greater than 8 in the postoperative recovery period.
Key exclusion criteria (7 listed)
- History of alcohol and/or substance abuse.
- Diagnosis of obstructive sleep apnea.
- History of pre-existing sleep disorders or use of additional sleep medications.
- Dementia or mild cognitive impairment.
- History of drug abuse, hepat renal dysfunction, psychosis, or neuropathy.
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 |
|---|---|---|
| Sleep Quality and Postoperative Pain AssessmentPreoperative sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Patients were classified as having good sleep quality (PSQI ≤ 5) or poor sleep quality (PSQI > 5). Postoperative pain intensity was evaluated using the Numeric Rating Scale (NRS) at predefined postoperative time points, including a three-month follow-up. No experimental therapeutic intervention was administered, and all perioperative care followed routine clinical practice. | Other | Breast Surgery Patients |
Primary outcome
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)
Time frame: 1, 6, 12, and 24 hours; 3 weeks; and 3 months postoperatively
Postoperative pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores were recorded at 1, 6, 12, and 24 hours, as well as 3 weeks and 3 months after surgery. NRS scores were compared between patients with good and poor preoperative sleep quality, classified according to the Pittsburgh Sleep Quality Index (PSQI).
4 secondary outcomes
Pain Catastrophizing Assessed by the Pain Catastrophizing Scale (PCS)
Time frame: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Anxiety Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Time frame: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Depression Assessed by the Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
Mental Health-Related Quality of Life Assessed by SF-12 Mental Component Summary (MCS)
Time frame: Within the first 24 hours postoperatively, at 3 weeks, and at 3 months after surgery
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 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient confidentiality and data privacy considerations. Study findings will be reported in an aggregated and anonymized format.
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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.
Ayşegül Bilen, MD principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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 Postoperative Pain and Preoperative Sleep Quality, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 7 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 23 Oct 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?
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?
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS) (time frame: 1, 6, 12, and 24 hours; 3 weeks; and 3 months 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 23 Oct 2026.