Pilot and Feasibility Study of a Mirrors Intervention for Reducing Delirium in Older Cardiac Surgical Patients

NCT ID: NCT01599689

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot cluster-randomised controlled trial aims to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The risk of delirium, an acute disturbance in mental status and cognition that occurs commonly after cardiac surgery, increases sharply from the age of about 65 years. Its occurrence, even for one day, is associated with longer ICU and hospital stays, increased costs, and negative physical and cognitive outcomes at one year. In spite of previous prevention and intervention research, delirium incidence in the older cardiac surgical patient remains high (up to 72%).

ICU clinicians at Papworth Hospital have made observations suggesting that delirium could be reduced using a novel and unconventional strategy of bedside mirrors. Mirrors of any type are uncommon in ICU environments\[1\], but their occasional use by patients on our ICU has been reported by bedside clinicians and physiotherapists to result in:

* a normalisation of mental status and attention (core delirium diagnostic criteria), and
* earlier physical mobilisation (associated with reduced delirium risk), particularly in older-aged patients

Evidence from other sources supports mirrors' beneficial effect in these areas \[2-10\], but mirror use has never to our knowledge been explored for the reduction of delirium. This pilot study seeks to determine whether the use of bedside mirrors, as a clearly defined part of patients' postsurgical ICU care, can reduce delirium and improve outcomes in the older cardiac surgical patient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirrors Intervention

Patients allocated to Mirrors will receive a structured, protocol-driven bedside mirrors intervention as part of their postsurgical ICU care. This intervention will commence as soon as all anaesthetic agents have been switched off and the patient is awake following surgery unless considered clinically inappropriate.

Group Type EXPERIMENTAL

Mirrors Intervention

Intervention Type OTHER

Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care.

To be administered at set times and in a standardised way by ICU nursing and physical therapy teams.

Standard Care

Patients allocated to Standard Care will receive the usual postsurgical ICU care that does not include the use of mirrors.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirrors Intervention

Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care.

To be administered at set times and in a standardised way by ICU nursing and physical therapy teams.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* scheduled for elective or urgent cardiac surgery at Papworth Hospital
* aged 70+ years

Exclusion Criteria

* inability to obtain informed consent
* care pathway anticipating admission elsewhere than to ICU following surgery
* severe visual impairment impeding ability to recognise self in mirror
* physical or communication barriers likely to impede effective administration of study procedures
* severe mental disability likely to impede effective administration of study procedures or assessment of delirium
* history of psychiatric illness previously requiring hospitalisation
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Alain Vuylsteke, MD

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Freysteinson WM. The use of mirrors in critical care nursing. Crit Care Nurs Q. 2009 Apr-Jun;32(2):89-93. doi: 10.1097/CNQ.0b013e3181a27b3d.

Reference Type BACKGROUND
PMID: 19300071 (View on PubMed)

Vanhaudenhuyse A, Schnakers C, Bredart S, Laureys S. Assessment of visual pursuit in post-comatose states: use a mirror. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):223. doi: 10.1136/jnnp.2007.121624. No abstract available.

Reference Type BACKGROUND
PMID: 18202215 (View on PubMed)

Tabak N, Bergman R, Alpert R. The mirror as a therapeutic tool for patients with dementia. Int J Nurs Pract. 1996 Sep;2(3):155-9. doi: 10.1111/j.1440-172x.1996.tb00042.x.

Reference Type BACKGROUND
PMID: 9265610 (View on PubMed)

Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.

Reference Type BACKGROUND
PMID: 10376620 (View on PubMed)

Tung ML, Murphy IC, Griffin SC, Alphonso AL, Hussey-Anderson L, Hughes KE, Weeks SR, Merritt V, Yetto JM, Pasquina PF, Tsao JW. Observation of limb movements reduces phantom limb pain in bilateral amputees. Ann Clin Transl Neurol. 2014 Sep;1(9):633-8. doi: 10.1002/acn3.89. Epub 2014 Sep 30.

Reference Type BACKGROUND
PMID: 25493277 (View on PubMed)

Giraud K, Pontin M, Sharples LD, Fletcher P, Dalgleish T, Eden A, Jenkins DP, Vuylsteke A. Use of a Structured Mirrors Intervention Does Not Reduce Delirium Incidence But May Improve Factual Memory Encoding in Cardiac Surgical ICU Patients Aged Over 70 Years: A Pilot Time-Cluster Randomized Controlled Trial. Front Aging Neurosci. 2016 Sep 28;8:228. doi: 10.3389/fnagi.2016.00228. eCollection 2016.

Reference Type DERIVED
PMID: 27733826 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SA16/0212

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

P01629

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Delirium-CS Canada Study
NCT02206880 COMPLETED