Pain Clinical Trial
Official title:
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Istituto CardioCentro | Lugano | Ticino |
Lead Sponsor | Collaborator |
---|---|
Schlotterbeck Hervé |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global pain intensity experienced during the procedure. | Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). | At the end of surgery | |
Secondary | Need for supplementary sedation and/or analgesia during the procedure. | The need for supplementary sedation and/or analgesia during the procedure will be recorded. The doses of the drugs will be recorded. | At the end of surgery | |
Secondary | Global anxiety intensity experienced during the procedure. | Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS). | At the end of surgery | |
Secondary | Patient's comfort during the procedure assessed by the surgeon and cardiologist. | Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS). | At the end of surgery | |
Secondary | Incidence of motion sickness during the virtual reality experience. | Incidence of motion sickness during the virtual reality experience (for example nausea) | At patient discharge (or at a maximum of 4 hours after the end of surgery) | |
Secondary | Patient's perceived procedure duration. | Patient's perceived procedure duration compared to effective procedure duration. | At the end of surgery | |
Secondary | Maximal systolic arterial blood pressure. | Maximal systolic arterial blood pressure recorded during the procedure. | At the end of surgery | |
Secondary | Incidence of hypotensive or hypoxic events during procedure. | 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. | At the end of surgery | |
Secondary | Total dose of local anaesthetic used during the procedure. | Total dose of local anaesthetic used during the procedure (total dose in mg). | At the end of surgery | |
Secondary | Change in anesthetic strategy during procedure. | If a change of anesthesiologic strategy is needed during the procedure (for example, if the patient needs an unplanned general anesthesia during the procedure). | At the end of surgery | |
Secondary | Interruption of virtual reality experience during the procedure. | If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure. | At the end of surgery | |
Secondary | Intra- and post-procedure complications. | Registration of any complication during and after the procedure. | At patient discharge (or at a maximum of 4 hours after the end of surgery) | |
Secondary | Overall patient's comfort and satisfaction experienced during the procedure. | Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points). | At patient discharge (or at a maximum of 4 hours after the end of surgery) |
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