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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immersive Soundscapes Environment | Experimental | Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure. |
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| Control Environment | No Intervention | Subjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have no music played during the procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive soundscapes | Other | Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape |
|
| 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 |
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Inclusion Criteria:
- English-speaking adults
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Meltzer, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |