Completed

Preoperative Sleep Quality and Anxiety Impact on Abdominal Gynecologic Cancer Surgery Outcomes

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Study Aim

This study observes how preoperative sleep quality and anxiety might affect postoperative pain in individuals undergoing abdominal gynecologic cancer surgery.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+23

+ Genital Diseases

+ Anxiety Disorders

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2025
See protocol details

Summary

Principal SponsorIzmir City Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how the quality of sleep and levels of anxiety before surgery affect recovery after abdominal surgery for gynecologic cancer. It targets women aged 18 and older who are scheduled for this type of surgery, excluding those with psychiatric or major neurological conditions. The research aims to find out if poor sleep or high anxiety might lead to more pain or complications after surgery. By identifying these links, the study hopes to improve preparation and care for patients undergoing these surgeries, potentially leading to better recovery outcomes. Participants in the study have their sleep quality and anxiety levels measured using specific questionnaires before their surgery. Sleep quality is assessed with the Pittsburgh Sleep Quality Index, and anxiety is measured with the Beck Anxiety Inventory. After surgery, their pain levels are tracked using a scale at several intervals, and additional data on pain medication needs, early complications like infections or nausea, and hospital stay duration are recorded. The study also considers factors like mobile phone use at night and satisfaction with pre-surgery counseling to see if these influence outcomes. Data is gathered through interviews and hospital records, with careful statistical analysis to ensure accurate results.

Official TitleImpact of Preoperative Sleep Quality and Anxiety on Postoperative Outcomes in Abdominal Gynecologic Cancer Surgery: A Prospective Observational Study
NCT07036549
Principal SponsorIzmir City Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAnxiety DisordersBehaviorMental DisordersBehavioral SymptomsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleSleep Initiation and Maintenance DisordersNeoplasmsNeoplasms by SiteNervous System DiseasesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsSleep Wake DisordersStress, PsychologicalPathological Conditions, Signs and SymptomsUrogenital NeoplasmsSleep Disorders, IntrinsicDyssomniasFemale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Female patients aged ≥18 years

Diagnosed with gynecologic malignancy

Scheduled for elective abdominal surgery (laparotomy)

Able to provide informed consent

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5 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

İzmir City Hospital

Izmir, Turkey (Türkiye)Open İzmir City Hospital in Google Maps
CompletedOne Study Center