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

Sponsor

University of Huelva (Other)

Overall Status

Completed

CT.gov ID

NCT05932394

Collaborator

(none)

105

Enrollment

Location

Arms

23.8

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium Postoperative Delirium Cardiac Surgery	Behavioral: Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery Behavioral: the usual unit treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Jun 26, 2023

Actual Study Completion Date :

Jun 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: the usual unit treatment CAM-ICU scale is administered to the Control group. No visual material is used.
Active Comparator: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: the usual unit treatment

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

Active Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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