Cardiac SurgeryNCT05143580
Preoperative Intervention to Reduce Delirium After Cardiac Surgery
A study testing Cognitive therapy and Routine care in people with Cardiac Surgery, run by Changhua Christian Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Cognitive therapy and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
- No cognitive impairment before surgery.
Who cannot join
- Diagnosed with aortic dissection.
- Previously admitted to the intensive care unit.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- Cognitive therapy, Routine care
- Keywords
- Delirium after cardiac surgery, Cognitive therapy, Gamification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive therapyBehavioural
- 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 careBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive therapy |
| 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. Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: When delirium occurs, assessment is conducted at 9 am every day until the end of delirium, an average of one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143580
- Sponsor's protocol ID
- CCH-CT-MZ01
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Cognitive Therapy Intervention in Reducing Delirium After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05143580
- Acronym / sponsor ID
- CCH-CT-MZ01
- Conditions
- Cardiac Surgery
- Keywords
- Delirium after cardiac surgery, Cognitive therapy, Gamification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 3 Dec 2021 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy Group | Experimental | 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. |
| Routine Care Group | Placebo comparator | 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Expected to undergo traditional thoracotomy or minimally invasive surgery for cardiac surgery.
- No cognitive impairment before surgery.
Key exclusion criteria (2 listed)
- Diagnosed with aortic dissection.
- Previously admitted to the intensive care unit.
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 |
|---|---|---|
| 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. | Behavioural | Cognitive Therapy Group |
| 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. | Behavioural | Routine Care Group |
Primary outcome
Incidence of delirium
Time frame: After surgery, the patient was evaluated at 48 hours.
* 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
Time frame: Completed through delirium, an average of one month.
- 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
Time frame: When delirium occurs, assessment is conducted at 9 am every day until the end of delirium, an average of one month.
* 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive therapy and Routine care in people with Cardiac Surgery, run by Changhua Christian Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang ShuPing, Professor (886-4-7238595 ext. 8442, 96148@cch.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: After surgery, the patient was evaluated at 48 hours.). The study lists 3 primary outcomes in all. 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 3 Dec 2021.