Preoperative Intervention to Reduce Delirium After Cardiac Surgery

NCT ID: NCT05143580

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-10-30

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Keywords

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Delirium after cardiac surgery Cognitive therapy Gamification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive therapy

Intervention Type BEHAVIORAL

* 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

* 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.

Group Type PLACEBO_COMPARATOR

Routine care

Intervention Type BEHAVIORAL

* 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

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Huang ShuPing, Professor

Role: CONTACT

Phone: 886-4-7238595

Email: [email protected]

Ke MengZhun, Master

Role: CONTACT

Phone: 886-9-83173601

Email: [email protected]

Other Identifiers

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CCH-CT-MZ01

Identifier Type: -

Identifier Source: org_study_id