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Clinical Trials/NCT04701801
NCT04701801CompletedNot Applicable

Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 site in 1 country200 target enrollmentStarted: October 21, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Determining the preoperative anxiety level and evaluating the difference between the preoperative moca test and the moca test performed on the postoperative 7th day (early period)

Study Overview

Brief Summary

Breast cancer is the most common type of cancer in women. Anxiety and depression often accompany the treatment phase of oncology patients.

Since both anxiety and depression are associated with increased inflammatory activity, these preoperative symptoms may predispose patients to the development of postoperative neurocognitive dysfunction.

The aim of this study is to reveal the correlation of preoperative anxiety with early postoperative cognitive dysfunction in patients with breast cancer who will undergo surgery.

Detailed Description

During the treatment of oncological disease, %13-19 of these patients show symptoms of anxiety and depression.Although many factors affect the development of postoperative cognitive dysfunction, there are several well-known risk factors and are thought to be due to increased inflammatory activity. Inflammation and immune dysfunction are common in oncological patients. It has also been reported that the presence of increased central nervous system inflammatory reactivity affects cognitive function.Since both anxiety and depression are associated with increased inflammatory activity, these preoperative symptoms may predispose patients to the development of postoperative neurocognitive dysfunction.

Postoperative cognitive dysfunction is an unwanted postoperative condition and is thought to be particularly relevant to elderly patients. Most studies in the literature have focused on the elderly. However, younger patients tend to experience more anxiety and depression during cancer treatment.

Studies indicate that age is inversely correlated with emotional distress and younger patients tend to experience higher levels of anxiety during diagnosis and treatment.

Also, younger patients have more limited life experiences to help them cope with such traumatic situations. The preoperative anxiety rate was found twice as high in female patients compared to male patients. Younger patients with bone cancer, breast cancer, and prostate cancer were three times more likely to report anxiety among the tumor groups than older patients.

Although the definition, degree and duration of postoperative cognitive dysfunction have been well researched, the effect of preoperative anxiety on the development of postoperative cognitive dysfunction has not been studied in detail.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Should be female
  • Should be between 18-65 years old
  • Diagnosed with breast cancer
  • Scoring 21 or above in the MoCA test,
  • Patients under general anesthesia
  • Are decided to have Total Mastectomy, Modified Radical Mastectomy or Breast Conserving surgery
  • Having a risk score of The American society of Anesthesiologists (ASA) risk score 3 and below

Exclusion Criteria

  • Cerebral ischemia or hemorrhage history
  • Clinical diagnosis of Neurodegenerative disease
  • Clinical diagnosis of carotid stenosis,
  • The score 20 or less in the Moca test,
  • Carotid endarterectomy history
  • Aneurysm surgery history
  • Alcohol addiction
  • Clinical diagnosis of psychiatric disease
  • Cervical surgery history
  • Inability to comply with the questionnaire or study
  • Chemotherapy history

Outcomes

Primary Outcomes

Determining the preoperative anxiety level and evaluating the difference between the preoperative moca test and the moca test performed on the postoperative 7th day (early period)

Time Frame: 7th postoperative day

The researcher will perform the neurocognitive level with a face-to-face interview with the moca test before surgery. In the postoperative period, the test will be repeated on the 7th day. If the moca test is above 21, it will be considered normal. and the patient will be enrolled. A decrease of 4 units in the moca test on the 7th postoperative day will be considered as postoperative cognitive dysfunction.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gizem Fariz

research assistant

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Study Sites (1)

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