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Effect of the Autonomous Sensory Meridian Response on pre-operative anxiety and vital signs : A prospective randomised placebo controlled research study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001235998
Enrollment
100
Registered
2020-11-18
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pr

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.

Sponsors

Associate Professor Stephanie Phillips
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients in the preoperative waiting area that consent to the study will be included and are 18 years old or older.

Exclusion criteria

Patients who are cognitively impaired, visually impaired, hearing impaired or who are not fluent in English.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026