NCT05650073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

December 6, 2022

Last Update Submit

August 21, 2025

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

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.

Other: Immersive soundscapes

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.

Interventions

Immersive soundscapesOTHER

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

Immersive Soundscapes Environment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- English-speaking adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ellen Meltzer, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

June 16, 2023

Primary Completion

May 2, 2025

Study Completion

July 15, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)