Effects of Cognitive Intervention Therapy on Postoperative Delirium
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
control group
Procedure/SurgeryThe 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
Procedure/SurgeryFor 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: control groupActive comparator 1 intervention
Group B: intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
from postoperative day 0 to postoperative day 7Secondary outcomes
1
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.
Time frame
from postoperative day 0 to postoperative day 72
duration of delirium
Time frame
from postoperative day 0 to postoperative day 73
type of delirium
Time frame
from postoperative day 0 to postoperative day 74
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.
Time frame
from postoperative day 0 to postoperative day 7Sponsors and contacts
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Source ClinicalTrials.gov
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