Varicose Veins
Conditions
Brief summary
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
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.
Interventions
OTHERImmersive soundscapes
Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
\- English-speaking adults
Exclusion criteria
* Patients needing an English interpreter * Patients who lack the capacity to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Report Visual Analog Pain Score | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | 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). |
| Change in Self-Report Visual Analog Anxiety Score | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | 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. |
| Change in Self-Report Visual Analog Stress Score | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | 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. |
| Change in Heart Rate | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | Number of beats per minute |
| Change in Blood Pressure | Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour | Measured in millimeters of mercury (mmHg) |
Countries
United States
Outcome results
None listed