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Breast CancerNCT07547774

Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

An observational study of Breast Cancer and Postoperative Pain, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Brief Summary: This prospective, single-center observational study examined the association between preoperative sleep quality and postoperative outcomes in women undergoing elective breast cancer surgery. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer, Postoperative Pain, Inflammation
What is being tested?
Preoperative Sleep Quality Assessment (PSQI)
How many people
128 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Apr 2026to 1 Oct 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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will include female patients aged 18-75 years undergoing elective breast cancer surgery at a tertiary oncology center. Eligible procedures include breast-conserving surgery, lumpectomy, and mastectomy with or without axillary dissection. Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). All patients will receive standard perioperative care without any intervention. This observational cohort represents real-world clinical practice and allows evaluation of the association between preoperative sleep quality and postoperative outcomes.

Who may be able to join

  • Female patients aged 18 to 75 years
  • Scheduled for elective breast cancer surgery
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Able to understand and complete the Pittsburgh Sleep Quality Index (PSQI)
  • Willing to participate in the study
  • Provided written informed consent

Who cannot join

  • Active infection
  • History of chronic inflammatory disease or autoimmune disease
  • Use of steroids or immunosuppressive drugs within the past 6 months
  • Known diagnosis of obstructive sleep apnea syndrome
  • Severe cognitive impairment preventing completion of the questionnaire
  • Planned emergency surgery
  • Refusal to participate or failure to provide informed consent

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

    Ankara, Yenimahalle, 06200

Other trials in Turkey (Türkiye)

About this study

Official title: Association of Preoperative Sleep Quality With 24-Hour Systemic Immune-Inflammation Index, Early PACU Pain, and Analgesic Use After Breast Cancer Surgery

  • Brief Summary:

This prospective, single-center observational study examined the association between preoperative sleep quality and postoperative outcomes in women undergoing elective breast cancer surgery. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), with scores ≤5 indicating good sleep quality and scores >5 indicating poor sleep quality.

Read more

The primary outcome was the systemic immune-inflammation index (SII), calculated from routine blood counts obtained 24 hours after surgery. Postoperative SII was compared between sleep-quality groups, accounting for preoperative SII and relevant clinical and surgical characteristics. Secondary outcomes included change in SII from baseline, pain intensity during the first 45 minutes in the post-anesthesia care unit (PACU), opioid consumption, rescue analgesic requirement, and length of hospital stay. Pain was assessed using a 10-cm visual analogue scale on PACU arrival and at 15, 30, and 45 minutes. Opioid consumption included morphine and tramadol administered during the final 20 minutes of surgery and the first 45 minutes in the PACU, expressed as intravenous morphine equivalents.

No treatment was assigned by the study protocol. Anesthetic and analgesic management followed routine clinical practice.

Read the detailed description

This prospective, single-center observational study examined the association between preoperative sleep quality and postoperative outcomes in women undergoing elective breast cancer surgery. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), with scores ≤5 indicating good sleep quality and scores >5 indicating poor sleep quality.

The primary outcome was the systemic immune-inflammation index (SII), calculated from routine blood counts obtained 24 hours after surgery. Postoperative SII was compared between sleep-quality groups, accounting for preoperative SII and relevant clinical and surgical characteristics. Secondary outcomes included change in SII from baseline, pain intensity during the first 45 minutes in the post-anesthesia care unit (PACU), opioid consumption, rescue analgesic requirement, and length of hospital stay. Pain was assessed using a 10-cm visual analogue scale on PACU arrival and at 15, 30, and 45 minutes. Opioid consumption included morphine and tramadol administered during the final 20 minutes of surgery and the first 45 minutes in the PACU, expressed as intravenous morphine equivalents.

No treatment was assigned by the study protocol. Anesthetic and analgesic management followed routine clinical practice.

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Detailed Description:

This prospective observational study was conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital in Ankara, Turkey, among women undergoing elective breast cancer surgery under general anesthesia. Procedures included lumpectomy or mastectomy, with axillary dissection when clinically indicated. The study examined whether preoperative sleep quality was associated with postoperative systemic immune-inflammation index (SII), immediate postoperative pain, and analgesic use.

Preoperative sleep quality was assessed using the validated Turkish version of the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Patients were classified as having good sleep quality (PSQI ≤5) or poor sleep quality (PSQI >5). Demographic characteristics, comorbidities, oncological history, surgical characteristics, and perioperative clinical data were recorded prospectively.

The primary outcome was SII measured 24 hours after surgery, calculated as platelet count × neutrophil count / lymphocyte count. Preoperative SII was calculated using the same formula. The primary analysis compared postoperative SII between sleep-quality groups, adjusting for baseline SII and clinical and surgical covariates. Change in SII, calculated as postoperative minus preoperative SII, was a secondary outcome.

Pain intensity was assessed using a 10-cm visual analogue scale (VAS), anchored at "no pain" and "worst imaginable pain." Patients marked their pain intensity on the line; the distance from the zero anchor was measured and rounded to the nearest whole centimeter. Assessments were performed on arrival in the post-anesthesia care unit (PACU) and at 15, 30, and 45 minutes. Maximum VAS was defined as the highest score across the four scheduled assessments. The pain assessor was unaware of patients' PSQI scores and sleep-quality groups.

Anesthetic and analgesic management followed routine clinical practice, with no treatment assigned by the study protocol. Intravenous morphine or tramadol was administered for postoperative analgesia during the final 20 minutes of surgery. Rescue analgesia consisted of intravenous morphine or tramadol when the PACU VAS score was ≥4; drug selection and dosing were determined by the treating anesthesiologist. Scheduled pain assessments continued after rescue treatment. No regional blocks or surgical local anesthetic infiltration were performed.

Total opioid consumption comprised morphine and tramadol administered during the final 20 minutes of surgery and the first 45 minutes in the PACU. Intravenous tramadol doses were converted to intravenous morphine equivalents using a factor of 0.1 and added to the administered morphine dose. Fentanyl used for induction and remifentanil used for maintenance were excluded from this measure. Rescue analgesic requirement was defined as receipt of at least one rescue opioid dose during the PACU observation period. Subsequent ward pain and analgesic use were not assessed. Length of hospital stay was also recorded.

Secondary analyses evaluated PSQI total score as a continuous predictor of postoperative SII, maximum VAS, total opioid consumption, and rescue analgesic requirement. Adjustment variables included age, body mass index, ASA physical status III, chronic disease burden, chemotherapy within the previous year, axillary dissection, and operation duration. Breast surgery type was added to the models during manuscript revision. Preoperative SII was included only in the postoperative SII models. Individual covariate-outcome associations were interpreted as exploratory.

Being tested
Preoperative Sleep Quality Assessment (PSQI)
Medical subject headings
Breast Neoplasms, Pain, Postoperative, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Sleep Quality Assessment (PSQI)Other

    Also called Pittsburgh Sleep Quality Index (PSQI)

    Preoperative sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire evaluating sleep quality over the previous month.

    Based on PSQI scores, patients will be categorized into two cohorts: good sleep quality (PSQI ≤ 5) and poor sleep quality (PSQI > 5). No intervention or modification to standard clinical care will be applied.

    All perioperative management will be conducted according to routine institutional protocols. This study is purely observational, and the PSQI assessment is used solely for grouping and analytical purposes.

Study groups in NCT07547774
Study groupRoleWhat they receive
Good Sleep Quality (PSQI ≤ 5)Patients with good preoperative sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score of 5 or less, will be included in this cohort. Sleep quality will be assessed during the preoperative period using the validated PSQI questionnaire. No intervention will be applied, and patients will receive standard perioperative care. Postoperative inflammatory response (SII), pain severity (VAS), and analgesic consumption will be recorded and compared with the poor sleep quality group.
Receives: Other: Preoperative Sleep Quality Assessment (PSQI)
Poor Sleep Quality (PSQI > 5)Patients with poor preoperative sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score greater than 5, will be included in this cohort. Sleep quality will be assessed during the preoperative period using the validated PSQI questionnaire. No intervention will be applied, and patients will receive standard perioperative care. Postoperative inflammatory response (SII), pain severity (VAS), and analgesic consumption will be recorded and compared with the good sleep quality group.
Receives: Other: Preoperative Sleep Quality Assessment (PSQI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Systemic Immune-Inflammation Index (SII)

    SII was calculated from routine complete blood count results using the formula: platelet count × neutrophil count / lymphocyte count. Postoperative SII was compared between patients with poor (PSQI >5) and good (PSQI ≤5) preoperative sleep quality, adjusting for preoperative SII and clinical and surgical covariates.

    Postoperative SII values will be compared between patients with good and poor preoperative sleep quality, as defined by the Pittsburgh Sleep Quality Index (PSQI). The analysis will evaluate whether preoperative sleep quality is associated with differences in postoperative inflammatory response.

    Measured: At 24 hours postoperatively (± 6 hours)

Secondary outcomes (3)
  1. Change in Systemic Immune-Inflammation Index (ΔSII)

    Change in SII was calculated as postoperative SII minus preoperative SII. SII was calculated at both time points as platelet count × neutrophil count / lymphocyte count. Changes were compared between patients with good (PSQI ≤5) and poor (PSQI >5) preoperative sleep quality.

    Measured: From the preoperative assessment to 24 hours after surgery.

  2. Immediate Postoperative Pain Intensity

    Pain intensity was assessed using a 10-cm visual analogue scale (VAS), anchored at 0 cm ("no pain") and 10 cm ("worst imaginable pain"). Patients marked their pain intensity on the line, and the measured distance was rounded to the nearest whole centimeter. Scores were recorded at each scheduled assessment, including after rescue analgesia when applicable. Maximum VAS was defined as the highest score across the four assessments

    Measured: On arrival in the post-anesthesia care unit (0 minutes) and at 15, 30, and 45 minutes after arrival.

  3. Total Opioid Consumption for Postoperative Analgesia

    Total opioid consumption was calculated as the sum of intravenous morphine and tramadol administered for postoperative analgesia during the final 20 minutes of surgery and the first 45 minutes in the post-anesthesia care unit (PACU), including rescue doses. Tramadol doses were multiplied by 0.1 to obtain intravenous morphine equivalents and added to the morphine dose. Consumption was expressed in milligrams of intravenous morphine equivalents. Fentanyl administered during induction and remifentanil used for maintenance were excluded.

    Measured: From 20 minutes before the end of surgery through the first 45 minutes after PACU arrival.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start17 Apr 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Oct 2026

Resources

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
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547774
Sponsor's protocol ID
2026-04/76
Status last verified
Oct 2026
First submitted
17 Apr 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. The study involves sensitive clinical data collected from patients in a single-center setting, and data sharing is restricted in order to protect patient confidentiality and comply with institutional and ethical regulations. De-identified and aggregated data may be available from the corresponding author upon reasonable request, subject to approval by the institutional ethics committee.

Publications

  • Irwin MR. Why sleep is important for health: a psychoneuroimmunology perspective. Annu Rev Psychol. 2015 Jan 3;66:143-72. doi: 10.1146/annurev-psych-010213-115205. Epub 2014 Jul 21.

    PubMed 25061767
  • Haack M, Simpson N, Sethna N, Kaur S, Mullington J. Sleep deficiency and chronic pain: potential underlying mechanisms and clinical implications. Neuropsychopharmacology. 2020 Jan;45(1):205-216. doi: 10.1038/s41386-019-0439-z. Epub 2019 Jun 17.

    PubMed 31207606
  • Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007.

    PubMed 24290442

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Postoperative Pain, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 6 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 21 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 Systemic Immune-Inflammation Index (SII) (time frame: At 24 hours postoperatively (± 6 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547774, which also lists 3 linked publications.

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 21 Oct 2026.

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