A Study of Soundscapes for Patient Wellbeing

Mayo Clinic73 enrolled

Overview

The purpose of this study is to assess the impact of immersive soundscape on patient pain, stress, anxiety, heart rate and blood pressure during an outpatient vascular surgery procedure.

Adult (≥18-years-old) patients having outpatient vascular surgery procedures who elect to participate in the study will be randomized to Control/ Intervention. For Control Subjects: procedure will be performed in the procedure room with no immersive soundscape. For Intervention Subjects procedure will be performed in the procedure room with immersive soundscape.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Varicose Veins

Interventions

Immersive soundscapesOTHER

Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- English-speaking adults Exclusion Criteria: * Patients needing an English interpreter * Patients who lack the capacity to provide consent.

Locations (1)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in Self-Report Visual Analog Pain Score

Using a ruler, patients select a pain score from 0, "no pain" to 100 "intolerable pain", with a higher score indicating greater pain. The distance between "0/ no pain" and the mark indicates the pain level. The following cut points for quantifying pain using a VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Change in Self-Report Visual Analog Anxiety Score

Using a ruler, patients select an anxiety score from 0, "no anxiety" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.

Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Change in Self-Report Visual Analog Stress Score

Using a ruler, patients select an anxiety score from 0, "no stress" to 100 "maximum anxiety imaginable", with a higher score indicating greater anxiety. The distance between "0/ no anxiety" and the mark indicates the anxiety level. Visual analogue scale for anxiety (VAS-A) has demonstrated to be a useful tool for measuring preoperative anxiety with a threshold for a clinically relevant level of anxiety at around 50mm.

Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Change in Heart Rate

Number of beats per minute

Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

Change in Blood Pressure

Data from ClinicalTrials.gov

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