A Study of Soundscapes for Patient Wellbeing

Back to results

Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Immersive soundscapes

About this trial

This is an interventional supportive care trial for Varicose Veins

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - English-speaking adults Exclusion Criteria: Patients needing an English interpreter Patients who lack the capacity to provide consent.

Sites / Locations

Mayo Clinic Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immersive Soundscapes Environment

Control Environment

Arm Description

Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.

Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have no music played during the procedure.

Outcomes

Primary Outcome Measures

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).

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.

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.

Change in Heart Rate

Number of beats per minute

Change in Blood Pressure

Measured in millimeters of mercury (mmHg)

Secondary Outcome Measures

Full Information

NCT ID

NCT05650073

First Posted

December 6, 2022

Last Updated

July 10, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05650073

Brief Title

A Study of Soundscapes for Patient Wellbeing

Official Title

Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 16, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicose Veins

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immersive Soundscapes Environment

Arm Type

Experimental

Arm Description

Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure.

Arm Title

Control Environment

Arm Type

No Intervention

Arm Description

Subjects having venous ablation with Vascular Surgery at Mayo Clinic will have no music played during the procedure.

Intervention Type

Other

Intervention Name(s)

Immersive soundscapes

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Self-Report Visual Analog Pain Score

Description

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).

Time Frame