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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delirium Behavior Cardiac Surgery Confusion Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Postoperative Complications Postoperative Delirium Psychological Well-Being Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Leon

León, Castille and León, 24008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

Behavioral

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

Primary outcomes

Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale

Time frame: 2 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) scale

Time frame: Baseline (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.

Sponsors and collaborators

Lead sponsor

University of Huelva

Other

Registry information

Acronym: VisualMaterial

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 6, 2023
Registry last updated: Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed