Gynecologic NeoplasmsNCT07036549
Impact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery
An observational study of Gynecologic Neoplasms, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effects of preoperative sleep quality and anxiety levels on postoperative outcomes in patients undergoing abdominal gynecologic cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Neoplasms
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 15 May 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged 18 years or older undergoing abdominal surgery for gynecologic malignancies at a tertiary oncology center between February and May 2025.
Who may be able to join
- Female patients aged ≥18 years
- Diagnosed with gynecologic malignancy
- Scheduled for elective abdominal surgery (laparotomy)
- Able to provide informed consent
- Completed preoperative sleep and anxiety assessments
Who cannot join
- History of psychiatric or cognitive disorders interfering with questionnaire participation
- Emergency surgical procedures
- Incomplete follow-up data within 30 days postoperatively
- Patients admitted for inpatient observation prior to surgery
- Major previous pelvic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery: A Prospective Observational Study
This prospective observational study aims to evaluate the effects of preoperative sleep quality and anxiety levels on postoperative outcomes in patients undergoing abdominal gynecologic cancer surgery. A total of 72 patients were included and assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Beck Anxiety Inventory (BAI) prior to surgery. Postoperative outcomes including pain scores (measured by the Numeric Rating Scale), complication rates, additional analgesic use, and length of hospital stay were recorded. The findings suggest that poor sleep quality and high anxiety levels prior to surgery are significantly associated with higher postoperative pain, increased complication rates, and prolonged hospital stay. These results emphasize the importance of preoperative psychological evaluation and supportive interventions to improve perioperative care in gynecologic oncology.
Read the detailed description
This prospective observational study was conducted between February and May 2025 at a tertiary gynecologic oncology center. The aim was to evaluate the association between preoperative sleep quality and anxiety levels with postoperative outcomes in patients undergoing open abdominal surgery for gynecologic cancer.
Eligible participants were women aged 18 years or older who were scheduled for elective laparotomy with general anesthesia. Patients with psychiatric disorders, major neurological conditions, or incomplete postoperative data were excluded.
Sleep quality was assessed preoperatively using the Pittsburgh Sleep Quality Index (PSQI), and anxiety was measured using the Beck Anxiety Inventory (BAI). Patients with a PSQI score ≥5 were classified as having poor sleep quality, and those with BAI scores ≥16 were classified as having high anxiety.
Postoperative pain was evaluated using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Additional analgesic requirements, early postoperative complications (e.g., surgical site infection, ileus, nausea-vomiting, atelectasis), and length of hospital stay were recorded.
The study also examined potential psychosocial contributors such as mobile phone use during sleep, internet-based health information seeking, and patients' satisfaction with preoperative counseling using a structured Likert scale.
All data were collected via face-to-face interviews and hospital records. Statistical analyses included Mann-Whitney U test, chi-square test, and Spearman correlation coefficients. The study was approved by the Institutional Ethics Committee (Approval No: 2025/38), and all participants provided written informed consent.
- Conditions
- Gynecologic Neoplasms
- Keywords
- Sleep Quality, Anxiety, Postoperative Pain, Gynecologic Cancer Surgery, Preoperative Assessment, Patient Outcomes, Psychological Stress, Hospital Stay
- Medical subject headings
- Genital Neoplasms, Female, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Pain, Postoperative, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Patients undergoing abdominal gynecologic cancer surgery were prospectively observed for postoperative outcomes including pain, complications, analgesic requirement, and hospital stay. Preoperative sleep quality and anxiety levels were measured and analyzed in relation to clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (Numeric Rating Scale)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Higher scores indicate greater pain intensity.
Measured: Postoperative Day 1 (within 24 hours after surgery)
Secondary outcomes (3)
Postoperative Complication Rate
Incidence of postoperative complications including surgical site infection, ileus, nausea-vomiting, and atelectasis recorded within 30 days after surgery.
Measured: Up to 30 days after surgery
Additional Analgesic Requirement
Requirement for rescue analgesics (non-protocol) within the first 24 hours postoperatively.
Measured: Postoperative Day 1 (within 24 hours after surgery)
Length of Hospital Stay
Duration of postoperative hospitalization measured in days from the day of surgery until the day of discharge, based on electronic medical records.
Measured: From day of surgery until discharge (mean: 4.2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 Feb 2025
- Primary completion20 Mar 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic NeoplasmsStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Celal Akdemir, Izmir City Hospital
- Investigators
- Celal Akdemir, md, Principal investigator, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036549
- Sponsor's protocol ID
- ISHSLANXPAIN
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akdemir C, Turan SA, Balci MF, Ozen S, Seker N, Bayramoglu D, Bayramoglu Z, Sanci M. Preoperative sleep quality and anxiety as predictors of postoperative pain and recovery in Gynecologic oncology surgery: A prospective observational study. J Psychosom Res. 2026 Feb;201:112496. doi: 10.1016/j.jpsychores.2025.112496. Epub 2025 Dec 11.
PubMed 41389754
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07036549
- Acronym / sponsor ID
- ISHSLANXPAIN
- Conditions
- Gynecologic Neoplasms
- Keywords
- Sleep Quality, Anxiety, Postoperative Pain, Gynecologic Cancer Surgery, Preoperative Assessment, Patient Outcomes, Psychological Stress, Hospital Stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 25 Jun 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 prospective observational study aims to evaluate the effects of preoperative sleep quality and anxiety levels on postoperative outcomes in patients undergoing abdominal gynecologic cancer surgery. A total of 72 patients were included and assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Beck Anxiety Inventory (BAI) prior to surgery. Postoperative outcomes including pain scores (measured by the Numeric Rating Scale), complication rates, additional analgesic use, and length of hospital stay were recorded. The findings suggest that poor sleep quality and high anxiety levels prior to surgery are significantly associated with higher postoperative pain, increased complication rates, and prolonged hospital stay. These results emphasize the importance of preoperative psychological evaluation and supportive interventions to improve perioperative care in gynecologic oncology.
Detailed description
This prospective observational study was conducted between February and May 2025 at a tertiary gynecologic oncology center. The aim was to evaluate the association between preoperative sleep quality and anxiety levels with postoperative outcomes in patients undergoing open abdominal surgery for gynecologic cancer.
Eligible participants were women aged 18 years or older who were scheduled for elective laparotomy with general anesthesia. Patients with psychiatric disorders, major neurological conditions, or incomplete postoperative data were excluded.
Sleep quality was assessed preoperatively using the Pittsburgh Sleep Quality Index (PSQI), and anxiety was measured using the Beck Anxiety Inventory (BAI). Patients with a PSQI score ≥5 were classified as having poor sleep quality, and those with BAI scores ≥16 were classified as having high anxiety.
Postoperative pain was evaluated using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Additional analgesic requirements, early postoperative complications (e.g., surgical site infection, ileus, nausea-vomiting, atelectasis), and length of hospital stay were recorded.
The study also examined potential psychosocial contributors such as mobile phone use during sleep, internet-based health information seeking, and patients' satisfaction with preoperative counseling using a structured Likert scale.
All data were collected via face-to-face interviews and hospital records. Statistical analyses included Mann-Whitney U test, chi-square test, and Spearman correlation coefficients. The study was approved by the Institutional Ethics Committee (Approval No: 2025/38), and all participants provided written informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | –Patients undergoing abdominal gynecologic cancer surgery were prospectively observed for postoperative outcomes including pain, complications, analgesic requirement, and hospital stay. Preoperative sleep quality and anxiety levels were measured and analyzed in relation to clinical outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 18 years or older undergoing abdominal surgery for gynecologic malignancies at a tertiary oncology center between February and May 2025.
Key inclusion criteria (5 listed)
- Female patients aged ≥18 years
- Diagnosed with gynecologic malignancy
- Scheduled for elective abdominal surgery (laparotomy)
- Able to provide informed consent
- Completed preoperative sleep and anxiety assessments
Key exclusion criteria (5 listed)
- History of psychiatric or cognitive disorders interfering with questionnaire participation
- Emergency surgical procedures
- Incomplete follow-up data within 30 days postoperatively
- Patients admitted for inpatient observation prior to surgery
- Major previous pelvic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain Score (Numeric Rating Scale)
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 8, 12, and 24 hours after surgery. Higher scores indicate greater pain intensity.
3 secondary outcomes
Postoperative Complication Rate
Time frame: Up to 30 days after surgery
Additional Analgesic Requirement
Time frame: Postoperative Day 1 (within 24 hours after surgery)
Length of Hospital Stay
Time frame: From day of surgery until discharge (mean: 4.2 days)
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 25 Jun 2025.
- Derived from this study: PubMed 41389754Akdemir C, Turan SA, Balci MF, Ozen S, Seker N, Bayramoglu D, Bayramoglu Z, Sanci M. Preoperative sleep quality and anxiety as predictors of postoperative pain and recovery in Gynecologic oncology surgery: A prospective observational study. J Psychosom Res. 2026 Feb;201:112496. doi: 10.1016/j.jpsychores.2025.112496. Epub 2025 Dec 11.
- Individual participant dataSharing planned: No
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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.
Celal Akdemir, md principal investigator
Izmir City Hospital
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 Gynecologic Neoplasms, run by Izmir City 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 5 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 25 Jun 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?
Postoperative Pain Score (Numeric Rating Scale) (time frame: Postoperative Day 1 (within 24 hours after surgery)). 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 NCT07036549, which also lists 1 linked publication.
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 25 Jun 2025.