A Study of Soundscapes for Patient Wellbeing

Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Other: Immersive soundscapes

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- English-speaking adults

Exclusion Criteria:

• Patients needing an English interpreter
• Patients who lack the capacity to provide consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ellen Meltzer, MD, MS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): May 2, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins
• Other Study ID Numbers: 22-008617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No