Spinal StenosisNCT06178939
Effects of Cognitive Intervention Therapy on Postoperative Delirium
A study testing intervention group in people with Spinal Stenosis and Disc Herniation, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Stenosis, Disc Herniation, Lung Neoplasms
- What is being tested?
- intervention group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
Seoul
Bon-Nyeo Koo, MD, PhD., 02-2227-7897, koobn@yuhs.ac
About this study
Official title: Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients
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.
- Being tested
- control group, intervention group
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Lung Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | 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. Receives: Procedure: control group |
| intervention group | Experimental | 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. Receives: Procedure: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: from postoperative day 0 to postoperative day 7
Secondary outcomes (4)
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.
Measured: from postoperative day 0 to postoperative day 7
duration of delirium
Measured: from postoperative day 0 to postoperative day 7
type of delirium
Measured: from postoperative day 0 to postoperative day 7
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.
Measured: from postoperative day 0 to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bon-Nyeo Koo, Principal investigator, Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178939
- Sponsor's protocol ID
- 4-2023-0872
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Intervention Therapy on Postoperative Delirium in Elderly Non-cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT06178939
- Acronym / sponsor ID
- 4-2023-0872
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: control groupThe 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 | Experimental | Procedure: intervention groupFor 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control groupThe 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. | Procedure or surgery | control group |
| intervention groupFor 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. | Procedure or surgery | intervention group |
Primary outcome
incidence of postoperative delirium
Time frame: 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).
4 secondary outcomes
comprehensive geriatric assessment(CGA),
Time frame: from postoperative day 0 to postoperative day 7
duration of delirium
Time frame: from postoperative day 0 to postoperative day 7
type of delirium
Time frame: from postoperative day 0 to postoperative day 7
total score of QOR-40
Time frame: from postoperative day 0 to postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bon-Nyeo Koo principal investigator
Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Spinal Stenosis and Disc Herniation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bon-Nyeo Koo, MD, PhD. (02-2227-7897, koobn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative delirium (time frame: from postoperative day 0 to postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.