search
Back to results

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

Primary Purpose

Delirium, Postoperative Delirium, Cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
the usual unit treatment
Sponsored by
University of Huelva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Delirium focused on measuring cardiac surgery, delirium, intensive care, visual material, mental health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Leon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control group

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2023
Last Updated
June 30, 2023
Sponsor
University of Huelva
search

1. Study Identification

Unique Protocol Identification Number
NCT05932394
Brief Title
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Acronym
VisualMaterial
Official Title
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
June 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Huelva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Postoperative Delirium, Cardiac Surgery
Keywords
cardiac surgery, delirium, intensive care, visual material, mental health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
the usual unit treatment
Intervention Description
CAM-ICU scale is administered to the Control group. No visual material is used.
Primary Outcome Measure Information:
Title
Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale
Description
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.
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.
Title
Mini-Mental State Examination (MMSE) scale
Description
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.
Time Frame
Baseline (Beginning of the experiment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital of Leon
City
Leon
State/Province
Castilla-Leon
ZIP/Postal Code
24008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data available under reasonable request to the principal investigator.

Learn more about this trial

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

We'll reach out to this number within 24 hrs