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Trial registered on ANZCTR


Registration number
ACTRN12617001198314
Ethics application status
Approved
Date submitted
10/08/2017
Date registered
16/08/2017
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does triggering an Autonomic Sensory Meridian Response (ASMR) reduce pre-operative anxiety?
Scientific title
Effect of a video designed to illicit the Autonomous Sensory Meridian Response on preoperative anxiety: A Randomized Placebo Controlled Trial
Secondary ID [1] 292510 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoperative Anxiety 304313 0
Condition category
Condition code
Anaesthesiology 303668 303668 0 0
Other anaesthesiology
Mental Health 303700 303700 0 0
Anxiety
Surgery 303701 303701 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved showing the preoperative patient in the preoperative ward a 6 minute video which provides information about the anesthetic procedure that they will receive. The video was shown to the patient around 1 - 2 hours prior to the induction of anesthetic. The video incorporated techniques known to illicit an Autonomous Sensory Meridian Response (ASMR). The patients' anxiety was assessed before and after the intervention.

ASMR is an alternative approach to relaxation and is currently very popular. The technique itself involves incorporating visual and acoustic stimuli delivered via video to elicit a low-grade euphoric response.
Intervention code [1] 298846 0
Behaviour
Intervention code [2] 298873 0
Prevention
Intervention code [3] 298874 0
Treatment: Other
Comparator / control treatment
The control involved having the patient watch a video providing information about the anesthetic procedure that they were going to receive. The content of the video is the same as the intervention video but was delivered normally without any ASMR elements.
Control group
Placebo

Outcomes
Primary outcome [1] 303040 0
Change from baseline value in preoperative anxiety as measured by the Visual Analogue Scale (VAS).

Timepoint [1] 303040 0
Visual Analogue Scale (VAS) was completed immediately prior to and after watching the intervention or the control video.
Primary outcome [2] 303081 0
Change from baseline value in preoperative anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
Timepoint [2] 303081 0
Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire was completed immediately prior to and after watching the intervention or the control video.
Primary outcome [3] 303082 0
Change from baseline value in preoperative anxiety as measured by the State-Trait Anxiety Inventory (STAI).
Timepoint [3] 303082 0
State-Trait Anxiety Inventory (STAI) questionnaire was completed immediately prior to and after watching the intervention or the control video.
Secondary outcome [1] 337757 0
Change in heart rate as measured by a Vital Signs Monitor.
Timepoint [1] 337757 0
Heart rate was recorded immediately before and after watching the intervention or control video.
Secondary outcome [2] 349774 0
Blood pressure measured manually using a sphygmomanometer.
Timepoint [2] 349774 0
Blood pressure recorded immediately before and after watching the intervention or control video.
Secondary outcome [3] 349775 0
Respiratory rate measured by counting a patient's breaths over 15 seconds and multiplying the number by 4 to get a value over 1 minute.
Timepoint [3] 349775 0
Respiratory rate recorded immediately before and after watching the intervention or control video.

Eligibility
Key inclusion criteria
Preoperative patients at the Sydney Adventist Hospital preparing to undergo a procedure requiring an anesthetic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Minors under 18 years old
- Inability to speak English
- Vision impaired (unable to view video)
- Hearing impaired (unable to hear video)
- Acutely unwell

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations were concealed. The sequence was generated beforehand using a random number generator. The intervention video and the control video was named by a third party so that the assessor did not know the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was done using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
16/01/2018
Date of last participant enrolment
Anticipated
Actual
6/02/2018
Date of last data collection
Anticipated
Actual
6/02/2018
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8754 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 16874 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 297080 0
Hospital
Name [1] 297080 0
Sydney Adventist Hospital
Country [1] 297080 0
Australia
Primary sponsor type
Individual
Name
David Ng
Address
Sydney Adventist Hospital Clinical School
Sydney Medical Program
185 Fox Valley Rd, Wahroonga NSW 2076
Country
Australia
Secondary sponsor category [1] 296084 0
Individual
Name [1] 296084 0
Kirsten Carlaw
Address [1] 296084 0
Sydney Adventist Hospital Clinical School
Sydney Medical Program
185 Fox Valley Rd, Wahroonga NSW 2076
Country [1] 296084 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298258 0
Adventist HealthCare Limited Human Research Ethics Committee (HREC)
Ethics committee address [1] 298258 0
Ethics committee country [1] 298258 0
Australia
Date submitted for ethics approval [1] 298258 0
Approval date [1] 298258 0
05/04/2017
Ethics approval number [1] 298258 0
2017-011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76502 0
A/Prof Stephanie Phillips
Address 76502 0
Northern Specialist Anaesthetics
San Clinic Tulloch, Suite 101, 185 Fox Valley Road
WAHROONGA
Country 76502 0
Australia
Phone 76502 0
+61418250280
Fax 76502 0
Email 76502 0
Stephanie.Phillips@sah.org.au
Contact person for public queries
Name 76503 0
Kirsten Carlaw
Address 76503 0
Sydney Adventist Hospital Clinical School
Sydney Medical Program
185 Fox Valley Rd, Wahroonga NSW 2076
Country 76503 0
Australia
Phone 76503 0
+61415831995
Fax 76503 0
Email 76503 0
kcar4850@uni.sydney.edu.au
Contact person for scientific queries
Name 76504 0
David Ng
Address 76504 0
Sydney Adventist Hospital Clinical School
Sydney Medical Program
185 Fox Valley Rd, Wahroonga NSW 2076
Country 76504 0
Australia
Phone 76504 0
+61401281663
Fax 76504 0
Email 76504 0
dang8322@uni.sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.