Local Anesthesia, Medical Device, Pain, Virtual Reality
Conditions
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.
Interventions
In this group, virtual reality will be added to usual care
Sponsors
Schlotterbeck Hervé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global pain intensity experienced during the procedure. | At the end of surgery | Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for supplementary sedation and/or analgesia during the procedure. | At the end of surgery | The need for supplementary sedation and/or analgesia during the procedure will be recorded. The doses of the drugs will be recorded. |
| Global anxiety intensity experienced during the procedure. | At the end of surgery | Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). |
| Patient's comfort during the procedure assessed by the surgeon and cardiologist. | At the end of surgery | Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS). |
| Incidence of motion sickness during the virtual reality experience. | At patient discharge (or at a maximum of 4 hours after the end of surgery) | Incidence of motion sickness during the virtual reality experience (for example nausea) |
| Patient's perceived procedure duration. | At the end of surgery | Patient's perceived procedure duration compared to effective procedure duration. |
| Maximal systolic arterial blood pressure. | At the end of surgery | Maximal systolic arterial blood pressure recorded during the procedure. |
| Incidence of hypotensive or hypoxic events during procedure. | At the end of surgery | Incidence of hypotensive events (defined by systolic arterial blood pressure less than 90 mmhg) and/or hypoxic events (defined by oxygen saturation under 90%) during the procedure. |
| Total dose of local anaesthetic used during the procedure. | At the end of surgery | Total dose of local anaesthetic used during the procedure (total dose in mg). |
| Change in anesthetic strategy during procedure. | At the end of surgery | If a change of anesthesiologic strategy is needed during the procedure (for example, if the patient needs an unplanned general anesthesia during the procedure). |
| Interruption of virtual reality experience during the procedure. | At the end of surgery | If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure. |
| Intra- and post-procedure complications. | At patient discharge (or at a maximum of 4 hours after the end of surgery) | Registration of any complication during and after the procedure. |
| 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) | Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points). |
Countries
Switzerland
Contacts
CONTACTHerve Schlotterbeck, MD
Outcome results
None listed