Preoperative Intervention to Reduce Delirium After Cardiac Surgery

Preoperative Cognitive Therapy Intervention in Reducing Delirium After Cardiac Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Behavioral: Cognitive therapy; Behavioral: Routine care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huang ShuPing, Professor; Phone Number: 8442 886-4-7238595; Email: 96148@cch.org.tw
• Study Contact Backup: Name: Ke MengZhun, Master; Phone Number: 886-9-83173601; Email: 177890@cch.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Therapy Group; 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.	Behavioral: Cognitive therapy; 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.
Placebo Comparator: Routine Care Group; 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.	Behavioral: Routine care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cognitive therapy; Gamification; Delirium after cardiac surgery
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: CCH-CT-MZ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No