Effects of Cognitive Intervention Therapy on Postoperative Delirium

Not Applicable

Not yet recruiting

• Conditions: Spinal Stenosis; Disc Herniation; Lung Neoplasms; Carcinoma, Hepatocellular
• Interventions: Procedure: control group; Procedure: intervention group

• Registration Number: NCT06178939
• Lead Sponsor: Yonsei University

Brief Summary

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Elderly patients aged 65 and above.
• Patients undergoing orthopedic, thoracic, or hepatopancreatobiliary surgery under general anesthesia with an expected surgery duration of 2 hours or more.
• Patients scheduled for arterial catheterization.

Exclusion Criteria

• Patients with uncontrolled systemic conditions such as diabetes and hypertension.
• Those with visual impairment.
• Patients with cognitive impairment based on the MMSE-DS criteria.
• Individuals experiencing difficulty in communication.
• Those diagnosed with neurological disorders (such as brain hemorrhage, stroke, brain tumor, dementia, Parkinson's disease, cognitive impairment, depression, etc.).
• Patients diagnosed with alcohol or substance addiction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control group	The entire process is carried out according to Severance Hospital surgical protocols. The patients of control group will receive education from the research team about the importance of nutrition and exercise before and after surgery.
intervention group	intervention group	For the intervention group, the entire process is carried out according to the Severance Hospital surgical protocol, and the research team provides education before surgery on the importance of nutrition and exercise before and after surgery. In addition, the cognitive training program developed by Rowan is taught with the goal of performing it for at least 10 hours before the surgery, it is conducted the training program after the surgery.

Primary Outcome Measures

Name	Time	Method
incidence of postoperative delirium	from postoperative day 0 to postoperative day 7	Confusion assessment methods(CAM) will be used to assess postoperative delirium at least two times a day during the hospitalization period. Patients diagnosed with delirium using the CAM were evaluated for the duration, symptoms, and type of delirium (e.g., reduced awareness of the environment; poor cognitive skills; behavioral changes, including hallucinations, restlessness, calling out, slowed movement, or lethargy; and emotional disturbances, such as anxiety, irritability, euphoria, apathy, unpredictable mood shift, and personality changes).

Secondary Outcome Measures

Name	Time	Method
type of delirium	from postoperative day 0 to postoperative day 7
comprehensive geriatric assessment(CGA),	from postoperative day 0 to postoperative day 7	Core component of CGA are as follows : functional capacity, fall risk, cognition, mood, polypharmacy, social support, financial concerns, goals of care, and advance care preferences.
duration of delirium	from postoperative day 0 to postoperative day 7
total score of QOR-40	from postoperative day 0 to postoperative day 7	The Quality of Recovery-40 (QoR-40) is a commonly utilized self-assessment questionnaire designed for postoperative patients. This survey is self-administered and aims to gather feedback from individuals about the quality of their recovery in the postoperative phase.; The QoR-40 is divided into categories such as emotional status, physical comfort, psychological support, physical independence, and pain. Max score of QoR-40 is 200.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of