Effects of Cognitive Intervention Therapy on Postoperative Delirium

Lung Neoplasms Clinical Trial

Official title:

Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178939
• Other study ID #: 4-2023-0872
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: October 2027

Study information

• Verified date: December 2023
• Source: Yonsei University
• Contact: Bon-Nyeo Koo, MD, PhD.
• Phone: 02-2227-7897
• Email: koobn[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Delirium
• Disc Herniation
• Emergence Delirium
• Intervertebral Disc Displacement
• Lung Neoplasms
• Spinal Stenosis

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative delirium	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).	from postoperative day 0 to postoperative day 7
Secondary	comprehensive geriatric assessment(CGA),	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.	from postoperative day 0 to postoperative day 7
Secondary	duration of delirium		from postoperative day 0 to postoperative day 7
Secondary	type of delirium		from postoperative day 0 to postoperative day 7
Secondary	total score of QOR-40	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.	from postoperative day 0 to postoperative day 7