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Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05932394
Acronym
VisualMaterial
Enrollment
105
Registered
2023-07-06
Start date
2021-07-01
Completion date
2023-06-26
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Delirium, Postoperative Delirium

Keywords

cardiac surgery, delirium, intensive care, visual material, mental health

Brief summary

The aim is to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium. 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.

Interventions

BEHAVIORALProjection 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.

BEHAVIORALthe usual unit treatment

CAM-ICU scale is administered to the Control group. No visual material is used.

Sponsors

University of Huelva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing heart surgery (aortic valve replacement, mitral valve replacement and/or coronary bypass) in the immediate postoperative period during their stay in the cardiac resuscitation unit. * Over 18 years of age

Exclusion criteria

* Not being sedated for at least 24 hours. * Leven of consciousness. * Spanish speaker.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale2 times, previous and post intervention, in the first 24 hours after cardiac surgery. This method is applied individually, through study completion, in an average of 1 year.Changes in the scale for the diagnosis of delirium in critical care units were assessed previous and post intervention of visual material projection. The final CAM-ICU-7 score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
Mini-Mental State Examination (MMSE) scaleBaseline (Beginning of the experiment)Initially, regardless of the group to which they belonged, all patients were administered the MMSE scale to assess their initial cognitive state and their sociodemographic and anthropometric data were collected. The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026