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Preoperative Intervention to Reduce Delirium After Cardiac Surgery

Primary Purpose

Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive therapy
Routine care
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Surgery focused on measuring Delirium after cardiac surgery, Cognitive therapy, Gamification

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
  • No cognitive impairment before surgery.

Exclusion Criteria:

  • Diagnosed with aortic dissection.
  • Previously admitted to the intensive care unit.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Cognitive Therapy Group

    Routine Care Group

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 28, 2021
    Last Updated
    November 21, 2021
    Sponsor
    Changhua Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05143580
    Brief Title
    Preoperative Intervention to Reduce Delirium After Cardiac Surgery
    Official Title
    Preoperative Cognitive Therapy Intervention in Reducing Delirium After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    October 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changhua Christian Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This study is an experimental quantitative research design. Both the control group and the experimental group provide routine nursing treatment and preoperative medical teaching manuals before surgery. The latter adds cognitive therapy and gamification evaluation of "Postoperative Care and Environmental Image Data Explanation". The two groups used CAM-ICU to assess the occurrence and duration of delirium after surgery, and DRS-R-98 was used to assess the severity of delirium. From 2021 to 2022, a simple random sampling method is adopted for patients undergoing cardiac surgery in the intensive care unit of a medical center in Central Taiwan, and a lottery is drawn on the first day of each month to determine the belong to which group in the current month. There were 55 persons in each group, and all subjects had no cognitive impairment. After the collected, it was analyzed and processed with SPSS 22.0 statistical package software. Expected results: The incidence of delirium, the duration of delirium, and the severity of delirium in the experimental group were significantly lower than the control group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Surgery
    Keywords
    Delirium after cardiac surgery, Cognitive therapy, Gamification

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Acceptance conditions: Patients who are expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery, and those who are over 20 years old and have no cognitive impairment before surgery. Excluded conditions: patients diagnosed with aortic dissection, over 80 years of age, and previously admitted to the intensive care unit.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive Therapy Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Routine Care Group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive therapy
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Routine care
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of delirium
    Description
    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.
    Time Frame
    After surgery, the patient was evaluated at 48 hours.
    Title
    Duration of delirium
    Description
    - When using the CAM-ICU assessment system, delirium occurs, and the time from the occurrence to the end of the delirium will be recorded.
    Time Frame
    Completed through delirium, an average of one month.
    Title
    Severity of delirium
    Description
    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.
    Time Frame
    When delirium occurs, assessment is conducted at 9 am every day until the end of delirium, an average of one month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery. No cognitive impairment before surgery. Exclusion Criteria: Diagnosed with aortic dissection. Previously admitted to the intensive care unit.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huang ShuPing, Professor
    Phone
    886-4-7238595
    Ext
    8442
    Email
    96148@cch.org.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ke MengZhun, Master
    Phone
    886-9-83173601
    Email
    177890@cch.org.tw

    12. IPD Sharing Statement

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    Preoperative Intervention to Reduce Delirium After Cardiac Surgery

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