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Completed

NCT Number: NCT05650073

A Study of Soundscapes for 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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking adults

Exclusion criteria

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

Treatment and study plan

Immersive soundscapes

Other

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

Primary outcomes

  1. Change in Self-Report Visual Analog Pain Score

    Time frame: 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).

  2. Change in Self-Report Visual Analog Anxiety Score

    Time frame: 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.

  3. Change in Self-Report Visual Analog Stress Score

    Time frame: 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.

  4. Change in Heart Rate

    Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

    Number of beats per minute

  5. Change in Blood Pressure

    Time frame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour

    Measured in millimeters of mercury (mmHg)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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