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

U

University of Huelva

Status

Completed

Conditions

Cardiac Surgery
Delirium
Postoperative Delirium

Treatments

Behavioral: the usual unit treatment
Behavioral: Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05932394
CEIm 2155

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 2 patient groups

Control group
Experimental group
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.
Treatment:
Behavioral: the usual unit treatment
Intervention group
Active Comparator group
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.
Treatment:
Behavioral: Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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