Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
NCT ID: NCT05932394
Last Updated: 2023-07-06
Study Results
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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COMPLETED
NA
105 participants
INTERVENTIONAL
2021-07-01
2023-06-26
Brief Summary
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A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. CONSORT guidelines were followed.
A control group and an intervention group were established. In the intervention group, the patients underwent a visual projection, while the usual unit treatment was carried out with the control group. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the "Confusion Assessment Method for the Intensive Care Unit scale" (CAM-ICU).
The projection of visual material could reduce the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established.
The results obtained suggest that the visual projection of images is an effective and economical tool to address an increasingly incidental problem due to the aging of the population.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Control group
In the control group, after the surgical intervention and 30 minutes after the patient's extubation the CAM-ICU scale is administered, recording its value as R0. The following day, at 9:00 a.m., another nurse uses the CAM-ICU scale, noting its value as R1. If postoperative delirium was detected during the day and night, the unit's usual treatment was followed: administration of haloperidol and/or dexmedetomidine.
the usual unit treatment
CAM-ICU scale is administered to the Control group. No visual material is used.
Intervention group
In the intervention group, patients and/or companions are asked to provide visual material, which could consist of photographs of loved ones and/or places known to the patient. 30 minutes after the extubation of the patients, the CAM-ICU scale is administered, recording its value as R0. At night, the projection of images provided by the patient are replaced by a nocturnal visual projection (night sky with stars and moon), ensuring that the patient is able to identify that it was nighttime. Finally, at 9:00 a.m., a nurse who had not worked at night and therefore did not know which patients had received the intervention, administers the CAM-ICU scale again, recording its value as R1.
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Patients are randomized into two groups (control group and intervention group). Initially, all patients are administered the "Mini-Mental State Examination scale" (MMSE) to assess their initial cognitive state and their sociodemographic and anthropometric data.
In the intervention group, patients and/or companions are asked to provide visual material, which could consist of photographs of loved ones and/or places known to the patient. 30 minutes after the extubation of the patients, the CAM-ICU scale is administered.
In the control group, after the surgical intervention and 30 minutes after the patient's extubation the CAM-ICU scale is administered.
Interventions
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Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Patients are randomized into two groups (control group and intervention group). Initially, all patients are administered the "Mini-Mental State Examination scale" (MMSE) to assess their initial cognitive state and their sociodemographic and anthropometric data.
In the intervention group, patients and/or companions are asked to provide visual material, which could consist of photographs of loved ones and/or places known to the patient. 30 minutes after the extubation of the patients, the CAM-ICU scale is administered.
In the control group, after the surgical intervention and 30 minutes after the patient's extubation the CAM-ICU scale is administered.
the usual unit treatment
CAM-ICU scale is administered to the Control group. No visual material is used.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
Exclusion Criteria
* Leven of consciousness.
* Spanish speaker.
18 Years
ALL
No
Sponsors
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University of Huelva
OTHER
Responsible Party
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Juan Gómez-Salgado
Professor
Locations
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University Hospital of Leon
León, Castille and León, Spain
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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CEIm 2155
Identifier Type: -
Identifier Source: org_study_id
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