NCT07036549

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

June 17, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Sleep QualityAnxietyPostoperative PainGynecologic Cancer SurgeryPreoperative AssessmentPatient OutcomesPsychological StressHospital Stay

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative Day 1 (within 24 hours after surgery)

Secondary Outcomes (3)

  • Postoperative Complication Rate

    Up to 30 days after surgery

  • Additional Analgesic Requirement

    Postoperative Day 1 (within 24 hours after surgery)

  • Length of Hospital Stay

    From day of surgery until discharge (mean: 4.2 days)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biologically female individuals undergoing gynecologic cancer surgery were eligible to participate.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir City Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Genital Neoplasms, FemaleSleep Initiation and Maintenance DisordersAnxiety DisordersPain, PostoperativeStress, Psychological

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Celal Akdemir, md

    Izmir City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

February 15, 2025

Primary Completion

March 20, 2025

Study Completion

May 15, 2025

Last Updated

June 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations