Effects of Cognitive Intervention Therapy on Postoperative Delirium

NCT ID: NCT06178939

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Stenosis Disc Herniation Lung Neoplasms Carcinoma, Hepatocellular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

intervention group

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bon-Nyeo Koo

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bon-Nyeo Koo, MD, PhD.

Role: CONTACT

Phone: 02-2227-7897

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bon-Nyeo Koo, MD, PhD.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2023-0872

Identifier Type: -

Identifier Source: org_study_id