A Study of Soundscapes for Patient Wellbeing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing

Conditions
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Varicose Veins

Intervention / Treatment
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* Other: Immersive soundscapes


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive Soundscapes Environment<br>Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure. | Other: Immersive soundscapes<br>* Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape<br>|
| No Intervention: Control Environment<br>Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have no music played during the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | 
| Change in Heart Rate | Number of beats per minute | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | 
| Change in Blood Pressure | Measured in millimeters of mercury (mmHg) | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour |