Recruiting NCT06346132
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual reality application.
- Who it may be relevant to
- Registry conditions: Virtual Reality, Medical Device, Local Anesthesia, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
Overview
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.
Interventions
- Device Virtual reality application
In this group, virtual reality will be added to usual care
Primary outcome measures
- Global pain intensity experienced during the procedure. [Time frame: At the end of surgery]
Secondary outcome measures (12)
- Need for supplementary sedation and/or analgesia during the procedure. [Time frame: At the end of surgery]
- Global anxiety intensity experienced during the procedure. [Time frame: At the end of surgery]
- Patient's comfort during the procedure assessed by the surgeon and cardiologist. [Time frame: At the end of surgery]
- Incidence of motion sickness during the virtual reality experience. [Time frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)]
- Patient's perceived procedure duration. [Time frame: At the end of surgery]
- Maximal systolic arterial blood pressure. [Time frame: At the end of surgery]
- Incidence of hypotensive or hypoxic events during procedure. [Time frame: At the end of surgery]
- Total dose of local anaesthetic used during the procedure. [Time frame: At the end of surgery]
- Change in anesthetic strategy during procedure. [Time frame: At the end of surgery]
- Interruption of virtual reality experience during the procedure. [Time frame: At the end of surgery]
- Intra- and post-procedure complications. [Time frame: 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. [Time frame: At patient discharge (or at a maximum of 4 hours after the end of surgery)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Istituto CardioCentro — Lugano
Identifiers
NCT: NCT06346132 · 2024-00043 CE 4516