Varicose VeinsNCT05650073
A Study of Soundscapes for Patient Wellbeing
A study testing Immersive soundscapes in people with Varicose Veins, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Immersive soundscapes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults
Who cannot join
- Patients needing an English interpreter
- Patients who lack the capacity to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- Immersive soundscapes
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive soundscapesOther
Audio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Change in Heart Rate
Number of beats per minute
Measured: 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)
Measured: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start16 Jun 2023
- Primary completion2 May 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen C. Meltzer, Mayo Clinic
- Investigators
- Ellen Meltzer, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650073
- Sponsor's protocol ID
- 22-008617
- Status last verified
- Aug 2025
- First submitted
- 6 Dec 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing
- ClinicalTrials.gov ID
- NCT05650073
- Acronym / sponsor ID
- 22-008617
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Soundscapes Environment | Experimental | Other: Immersive soundscapesSubjects having venous ablation OR port removal with Vascular Surgery at Mayo Clinic will have relaxing music and relaxing sounds played during the procedure. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking adults
Key exclusion criteria (2 listed)
- Patients needing an English interpreter
- Patients who lack the capacity to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive soundscapesAudio technology used to create a three-dimensional sound experience in which the user is immersed in a virtual soundscape | Other | Immersive Soundscapes Environment |
Primary outcome
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).
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.
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.
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Meltzer, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive soundscapes in people with Varicose Veins, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.