Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001235998
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
18/11/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
18/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of the Autonomous Sensory Meridian Response on pre-operative anxiety and vital signs : A prospective randomised placebo controlled research study
Scientific title
Effect of the Autonomous Sensory Meridian Response on pre-operative anxiety and vital signs in adults undergoing surgery: A prospective randomised placebo controlled research study
Secondary ID [1] 302366 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 319148 0
vital signs monitoring 319149 0
Condition category
Condition code
Surgery 317108 317108 0 0
Other surgery
Alternative and Complementary Medicine 317109 317109 0 0
Other alternative and complementary medicine
Mental Health 317410 317410 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomised placebo controlled research study, patients in the preoperative waiting room of the Sydney Adventist Hospital (Wahroonga, NSW) will be asked to volunteer to participate in this study to be conducted by university student investigators who will deliver the intervention. Once consent is obtained, adequate privacy of the participants will be ensured by measures such as drawing the curtains in their waiting bay. Participants will have their vital signs measured; including blood pressure, heart rate and respiratory rate; and their anxiety assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), the State-Trait Anxiety Inventory(STAI), and the Visual Analogue Scale (VAS). Participants will then undergo randomisation into two groups: Group 1 to watch a standardised audio-visual ASMR stimulus; and Group 2 to watch a standardised placebo video which is similar but does not contain ASMR triggers. Each video lasts approximately 5 minutes. The video will be delivered on an electronic device such as a tablet or laptop with headphones. The study will use REDCap (Research Electronic Capture Data) to deliver the video and questionnaires Following this intervention, both groups will have their vital signs measured and their anxiety assessed using the methods described above a second time. Following this, both groups will be asked “Did you experience a tingling sensation or mood change during the intervention?” Responders to ASMR will be identified based on this assessment. The total intervention will take approximately 15 minutes, and adherence to the intervention will be monitored by the investigators present at the time of the intervention.
Intervention code [1] 318652 0
Treatment: Other
Comparator / control treatment
Group 2 is the control treatment group and will be asked to watch a standardised placebo video which is similar but does not contain ASMR triggers.
Control group
Placebo

Outcomes
Primary outcome [1] 325195 0
pre-operative anxiety, as assessed by the State-Trait Anxiety Inventory (STAI), the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and the Visual Analogue Scale (VAS) questionnaires
Timepoint [1] 325195 0
immediately pre and post intervention
Secondary outcome [1] 387154 0
physiological changes in blood pressure assessed by sphygmomanometer
Timepoint [1] 387154 0
immediately pre and post intervention
Secondary outcome [2] 387970 0
physiological changes in heart rate assessed by radial pulse
Timepoint [2] 387970 0
immediately pre and post intervention
Secondary outcome [3] 387974 0
physiological changes in respiratory rate assessed by rise and fall of the chest whilst taking radial pulse
Timepoint [3] 387974 0
immediately pre and post intervention

Eligibility
Key inclusion criteria
Patients in the preoperative waiting area that consent to the study will be included and are 18 years old or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are cognitively impaired, visually impaired, hearing impaired or who are not fluent in English.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by REDCap
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Descriptive statistics will be used to analyse demographic data. A paired T-test will be used to detect changes in vital signs and anxiety scores before and after the intervention. A power of 90% with a confidence level of 95% will be required to detect the desired change in anxiety scores. A linear regression model will be used for the analysis of data with; dependent variable: e.g. post anxiety score, and predictors: treatment group, pre anxiety score, any other confounders (age, sex). The sample size is variable in initial stage, depending on number of responders identified. 100 to be included in measurement of anxiety and vital signs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17597 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 31342 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 306796 0
University
Name [1] 306796 0
University of Sydney
Country [1] 306796 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Stephanie Phillips
Address
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country
Australia
Secondary sponsor category [1] 307348 0
Individual
Name [1] 307348 0
Clare Atkinson
Address [1] 307348 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country [1] 307348 0
Australia
Secondary sponsor category [2] 307351 0
Individual
Name [2] 307351 0
Gurmehar Gill
Address [2] 307351 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country [2] 307351 0
Australia
Secondary sponsor category [3] 307352 0
Individual
Name [3] 307352 0
Andrea Wright
Address [3] 307352 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country [3] 307352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306954 0
Adventist HealthCare Limited Ethics Committee
Ethics committee address [1] 306954 0
185 Fox Valley Rd, Wahroonga NSW 2076
Ethics committee country [1] 306954 0
Australia
Date submitted for ethics approval [1] 306954 0
Approval date [1] 306954 0
15/09/2020
Ethics approval number [1] 306954 0
AHCL Study ID: 2020-007

Summary
Brief summary
The primary objective of this study is to investigate whether an ASMR intervention produces a measurable difference on pre-operative anxiety and primary vital signs using a randomised placebo controlled research study. Validated tools, the Amsterdam Preoperative Anxiety and Information Scale (APAIS), State-Trait Anxiety Inventory (STAI) questionnaire and Visual Analogue Scale (VAS) will be used to assess the pre-operative anxiety. Measuring the blood pressure and respiratory rate will assess the pre-operative primary vital signs. We hypothesise that for responders to ASMR, the intervention will improve anxiety scores and improve vital signs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105570 0
A/Prof Stephanie Phillips
Address 105570 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country 105570 0
Australia
Phone 105570 0
+61418250280
Fax 105570 0
Email 105570 0
[email protected]
Contact person for public queries
Name 105571 0
Miss Clare Atkinson
Address 105571 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country 105571 0
Australia
Phone 105571 0
+61 404785458
Fax 105571 0
Email 105571 0
[email protected]
Contact person for scientific queries
Name 105572 0
Miss Clare Atkinson
Address 105572 0
185 Fox Valley Rd, Wahroonga NSW 2076
Sydney Adventist Hospital
Country 105572 0
Australia
Phone 105572 0
+61 404785458
Fax 105572 0
Email 105572 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
Individual patient data will not be shared as the data will be pooled and analysed as a group rather than individually.


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.