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Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures

Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04279665
Enrollment
0
Registered
2020-02-21
Start date
2020-06-20
Completion date
2021-01-01
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Brief summary

Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.

Interventions

20 minutes of wearing a virtual reality headset with a choice of 4 environments based on their preference and another 20 minutes with a less immersive condition

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation

Exclusion criteria

* Patients unable to consent

Design outcomes

Primary

MeasureTime frameDescription
Subject anxiety20 minutesMeasured using a survey question asking participants to rank their anxiety level over the last 20 minutes using a scale of 5 being extremely good (ie, less anxiety); 1 being extremely bad (ie, more anxiety).
Subject comfort20 minutesMeasured using a survey question asking participants to rank their comfort over the last 20 minutes using a scale of 5 being extremely positive; 4 being somewhat positive; 3 being neutral; 2 being somewhat negative; 1 being extremely negative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026