NCT06346132RecruitingNot Applicable
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
Schlotterbeck Hervé1 site in 1 country150 target enrollmentStarted: March 29, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Global pain intensity experienced during the procedure.
Study Overview
Brief Summary
The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 year old,
- •Patients who signed the consent form and accepted to participate to the trial,
- •New cardiac electronic device implantation or cardiac electronic device battery change,
- •Surgical procedure planned in ambulatory care.
Exclusion Criteria
- •Communication limitations,
- •Surgical procedure planned in sedation or narcosis,
- •Severe sensorial deficits (visual, auditory),
- •Claustrophobia,
- •Known motion sickness,
- •Patient isolated or with contact precautions,
- •Known or anticipated psychiatric diseases,
- •Patient known for epilepsia,
- •Opened scar and or ongoing infection at the level of the face and/or eyes,
- •Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.
Outcomes
Primary Outcomes
Global pain intensity experienced during the procedure.
Time Frame: At the end of surgery
Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).
Secondary Outcomes
- Need for supplementary sedation and/or analgesia during the procedure.(At the end of surgery)
- Total dose of local anaesthetic used during the procedure.(At the end of surgery)
- Change in anesthetic strategy during procedure.(At the end of surgery)
- Global anxiety intensity experienced during the procedure.(At the end of surgery)
- Patient's perceived procedure duration.(At the end of surgery)
- Incidence of hypotensive or hypoxic events during procedure.(At the end of surgery)
- Interruption of virtual reality experience during the procedure.(At the end of surgery)
- Patient's comfort during the procedure assessed by the surgeon and cardiologist.(At the end of surgery)
- Maximal systolic arterial blood pressure.(At the end of surgery)
- Incidence of motion sickness during the virtual reality experience.(At patient discharge (or at a maximum of 4 hours after the end of surgery))
- Intra- and post-procedure complications.(At patient discharge (or at a maximum of 4 hours after the end of surgery))
- Overall patient's comfort and satisfaction experienced during the procedure.(At patient discharge (or at a maximum of 4 hours after the end of surgery))
Investigators
Schlotterbeck Hervé
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona
Study Sites (1)
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