Trial Review

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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] 300227 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional Trauma 316195 0
Pain Management 316196 0
Mental Health Management 316197 0
Condition category
Condition code
Emergency medicine 314079 314079 0 0
Other emergency care
Mental Health 314487 314487 0 0
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] 316500 0
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] 322469 0
Change in overall comfort as assessed by PEECE score
Timepoint [1] 322469 0
60 minutes post enrolment
Primary outcome [2] 322816 0
Change in analgesia requirements between treatment groups, assessed by considering medication charts and clinical observations
Timepoint [2] 322816 0
60 minutes post enrolment
Secondary outcome [1] 378636 0
N/A
Timepoint [1] 378636 0
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?
No
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
40
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15603 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 29002 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304657 0
Hospital
Name [1] 304657 0
The Alfred Hospital’s Emergency &; Trauma Centre
Country [1] 304657 0
Australia
Funding source category [2] 304658 0
Hospital
Name [2] 304658 0
Alfred Health Innovation Grant
Country [2] 304658 0
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] 304962 0
None
Name [1] 304962 0
Address [1] 304962 0
Country [1] 304962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305078 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 305078 0
The Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 305078 0
Australia
Date submitted for ethics approval [1] 305078 0
31/10/2018
Approval date [1] 305078 0
17/12/2018
Ethics approval number [1] 305078 0
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 99190 0
Dr Andrew Underhill
Address 99190 0
The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004
Country 99190 0
Australia
Phone 99190 0
+61 434575985
Fax 99190 0
Email 99190 0
[email protected]
Contact person for public queries
Name 99191 0
Dr Andrew Underhill
Address 99191 0
The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004
Country 99191 0
Australia
Phone 99191 0
+61 434575985
Fax 99191 0
Email 99191 0
[email protected]
Contact person for scientific queries
Name 99192 0
Dr Andrew Underhill
Address 99192 0
The Alfred Hospital - Emergency Department
55 Commercial Rd, Melbourne VIC 3004
Country 99192 0
Australia
Phone 99192 0
+61 434575985
Fax 99192 0
Email 99192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6378Study protocol    379033-(Uploaded-10-01-2020-15-45-22)-Study-related document.docx
6380Informed 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.