ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000308998

Ethics application status

Approved

Date submitted

10/01/2020

Date registered

5/03/2020

Date last updated

5/03/2020

Date data sharing statement initially provided

5/03/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does sensory mindfulness improve emotional comfort in patients with spinal precautions in emergency departments? A pilot study.

Scientific title

Does sensory mindfulness improve emotional comfort in patients with spinal precautions in emergency departments? A pilot study.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Emotional Trauma

Pain Management

Mental Health Management

Condition category

Condition code

Emergency medicine

Other emergency care

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will be administered the patient when the patient is transferred to the Short Stay Unit (SSU) at ED, for a period of up to 60 minutes.

The intervention will be meditation and nature videos delivered using a sensory mindfulness cart. The cart will deliver mindfulness content using a customised mobile integrated patient controlled immersive audio visual display therapeutic tool to facilitate relaxation and reduce anxiety which has been specifically designed for immobilised trauma patients. The content includes guided audio meditations and nature videos. The categories of these meditations are to "feel calm", "help sleep" and "relax and cover". The nature videos are of relaxing sounds of nature such as running stream, rain dripping from leaves, waves on a beach and a bird singing.

The compliance of usage of this cart will be monitored at random intervals by research personnel, with collateral history being obtained by nurses and other medical staff. Patient self-reporting compliance will also be taken into account.

This intervention will be compared to standard care, and in the long-term, hope to be able to use this as an adjunct to standard care that patients are able to request as required.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group will be given standard care - they will be left alone/with any family in the room, and followed up with at 60min with a further questionnaire.

Control group

Active

Outcomes

Primary outcome [1]

Change in overall comfort as assessed by PEECE score

Timepoint [1]

60 minutes post enrolment

Primary outcome [2]

Change in analgesia requirements between treatment groups, assessed by considering medication charts and clinical observations

Timepoint [2]

60 minutes post enrolment

Secondary outcome [1]

N/A

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

Eligible patients will be those who are:
• Patients admitted to the emergency short stay unit at Alfred Hospital
• in spinal precautions
• normal mentation
• passed a 4 A’s Test (4AT)
• not requiring an interpreter
• no clinically significant visual or hearing impairment
• may or may not have symptoms suggestive of concussion

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria
- Anyone with a 4AT score > 0 (This has been specifically chosen to exclude those patients who have any evidence of delirium)
- Symptoms of mild TBI vomiting, severe headache, dizziness

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed Opaque Envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Baseline variables will be summarized using descriptive statistics and compared using the
Student’s t-test (continuous, normally distributed variables) or the Chi-squared test
(proportions) or Fisher’s Exact test (proportions where value in a cell is <5. An increase of
10% in the proportion of patients achieving the primary outcome of interest will be
considered to be clinically significant. Assuming 95% confidence intervals and 80% power to
detect this difference, the sample size required for this study is 774. In this pilot study, we
aim to enroll 40 patients (20 patient per arm) to demonstrate feasibility of the research
protocol in determining emotional comfort via the PEECE score with and without the device.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

15/04/2019

Date of last participant enrolment

Anticipated

30/04/2020

Actual

Date of last data collection

Anticipated

30/04/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital’s Emergency &; Trauma Centre

Address [1]

The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Alfred Health Innovation Grant

Address [2]

The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004

Country [2]

Australia

Primary sponsor type

Hospital

Name

The Alfred Hospital’s Emergency &; Trauma Centre

Address

The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/10/2018

Approval date [1]

17/12/2018

Ethics approval number [1]

45401

Summary

Brief summary

The Alfred and Emergency and Trauma centre sees in excess of 65,000 patients per annum
which includes approximately 8,000 trauma presentations. Close to 40% of these
presentations will be admitted to hospital, with a substantial number requiring spinal
immobilisation for a period of time prior to spinal clearance. Of these, 20%, (approx. 1500
patients per year ) are admitted to the Alfred emergency short stay unit (SSU). Such patients are often required to lie flat in bed, with direct visual contact with the ceiling of the Emergency Department. These is often no visual stimulation for this group of patients which can lead to agitation, aggression, fear and anxiety, which often results in reduced compliance with spinal immobilisation.

This study aims to demonstrate improved emotion comfort among spinally immobilised
patients in the emergency department short stay unit by providing sensory mindfulness
content using a customised mobile integrated patient controlled immersive audio visual
device as a therapeutic tool to facilitate relaxation which has been specifically designed for
immobilised trauma patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Underhill

Address

The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 434575985

Fax

A.Underhill@alfred.org.au

Contact person for public queries

Name

Andrew Underhill

Address

The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 434575985

Fax

A.Underhill@alfred.org.au

Contact person for scientific queries

Name

Andrew Underhill

Address

The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 434575985

Fax

A.Underhill@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Confidentiality

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6378	Study protocol					379033-(Uploaded-10-01-2020-15-45-22)-Study-related document.docx
6380	Informed consent form					379033-(Uploaded-10-01-2020-15-45-43)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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