Virtual Reality Assisted Conscious Sedation During TAVI

Pain Clinical Trial

— TAVI_VR  

Official title:

Virtual Reality Assisted Conscious Sedation During Transcatheter Aortic Valve Implantation - a Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259723
• Other study ID #: 19-007
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Interventional transfemoral TAVI

• Informed consent

• Normal or corrected vision (through glasses)

Exclusion Criteria:

• Patients whose communication is limited due to a language barrier

• Patients who could not watch the 3D video due to uncorrectable vision

• all patients with transapical TAVI were also excluded.

Related Conditions & MeSH terms

• Anxiety
• Aortic Valve Stenosis
• Pain
• Severe Aortic Valve Stenosis

Intervention

Other:
• VR during TAVI
Virtual Reality (VR) glasses

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety	A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)	at Baseline
Primary	Change in anxiety	A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no anxiety, 10=maximum anxiety/extremly anxious)	after 24 hours
Secondary	Time of VR	The time [min] of VR use will be recorded during the procedure	at Baseline
Secondary	Evaluation of clinical frailty scale	The Clinical Frailty Scale (CFS) is a simple model visually describing patients physical conditions with nine classes from very fit (class 1) to terminally ill (class 9).	at Baseline
Secondary	Measurement of pain: visual analog scale	A visual analog scale will be used to determine the level of pain after the procedure. A visual analog scale will be used to determine the level of anxiety before and after the procedure. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0=no pain, 10=unbearable pain)	after 24 hours
Secondary	Length of stay at hospital	The length of stay at hospital will be recorded.	up to 5 days
Secondary	Occurence of vomitting	Patients will be asked during and after the procedure for safety problems with special regards to vomiting	at Baseline, periprocedural and after 24 hours
Secondary	Occurence of nausea	Patients will be asked during and after the procedure for safety problems with special regards to nausea	at Baseline, periprocedural and after 24 hours
Secondary	Rate of Intra-hospital mortality	The intra-hospital mortality will be assessed after discharge	up to 5 days