Preoperative Intervention to Reduce Delirium After Cardiac Surgery
Preoperative Cognitive Therapy Intervention in Reducing Delirium After Cardiac Surgery
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
This research is designed for experimental quantitative research and is conducted by simple random sampling. Both the control group and the experimental group provided preoperative routine nursing treatment and preoperative medical teaching manuals. The latter adds cognitive therapy and gamification evaluation. Both groups used CAM-ICU to assess the occurrence and duration of postoperative delirium, and DRS-R-98 was used to assess the severity of delirium. After collection, use SPSS 22.0 statistical software package for analysis and processing. The expected result is that the incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than those in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedDecember 3, 2021
October 1, 2021
11 months
October 28, 2021
November 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of delirium
* First use the Richmond Restlessness and Sedation Scale (RASS) to assess the state of consciousness. RASS is a 10-point scale. +1 to +4 represent different levels of anxiety, 0 points represent alertness and calmness, and -1 to -5 represent different levels of sedation. * When the RASS score is between -3 and +4, then evaluate the Confusion Assessment Method for the intensive care unit (CAM-ICU). The CAM-ICU is a four-step assessment method with items on altered mental status or fluctuating course, inattention, and altered level of consciousness or disorganized thinking. * If the evaluation result is the following two combinations, the first combination is mental state change, inattention, and consciousness level change; the second combination is mental state change, inattention, and disorganized thinking. This means that the CAM-ICU is positive and delirium has occurred.
After surgery, the patient was evaluated at 48 hours.
Duration of delirium
\- When using the CAM-ICU assessment system, delirium occurs, and the time from the occurrence to the end of the delirium will be recorded.
Completed through delirium, an average of one month.
Severity of delirium
* When delirium occurs, use Delirium Rating Scale-Revised-98 (DRS-R-98) to score the severity of delirium symptoms. * DRS-R-98 has a total of 16 scoring items, including 13 delirium severity and 3 diagnosis items. The total score is up to 46 points, of which the highest severity is 39 points. The higher the score, the more serious. * Clinically, the total score ≥ 18 points or the severity score ≥ 15 points are used.
When delirium occurs, assessment is conducted at 9 am every day until the end of delirium, an average of one month.
Study Arms (2)
Cognitive Therapy Group
EXPERIMENTAL* The anesthesiologist will provide the patient with instructions for preoperative anesthesia. * The operating room nurses will introduce the operating room environment and surgical care instructions to the patient. * Provide a manual for disease health education. * Provide post-operative care and environmental imaging materials, explain the importance of intensive care unit routines and related equipment, indwelling pipelines, related nursing staff, post-operative care methods, and provide imaging and health education manuals for explanation. * Use gamification to evaluate: pain relief skills, lung expansion skills.
Routine Care Group
PLACEBO COMPARATOR* The anesthesiologist will provide the patient with instructions for preoperative anesthesia. * The operating room nurses will introduce the operating room environment and surgical care instructions to the patient. * Provide a manual for disease health education.
Interventions
* The anesthesiologist will provide the patient with instructions for preoperative anesthesia. * The operating room nurses will introduce the operating room environment and surgical care instructions to the patient. * Provide a manual for disease health education. * Provide post-operative care and environmental imaging materials, explain the importance of intensive care unit routines and related equipment, indwelling pipelines, related nursing staff, post-operative care methods, and provide imaging and health education manuals for explanation. * Use gamification to evaluate: pain relief skills, lung expansion skills.
* The anesthesiologist will provide the patient with instructions for preoperative anesthesia. * The operating room nurses will introduce the operating room environment and surgical care instructions to the patient. * Provide a manual for disease health education.
Eligibility Criteria
You may qualify if:
- Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
- No cognitive impairment before surgery.
You may not qualify if:
- Diagnosed with aortic dissection.
- Previously admitted to the intensive care unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
December 3, 2021
Study Start
December 1, 2021
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
December 3, 2021
Record last verified: 2021-10