Clinical trial NCT06346132: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
Official title: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Medical Device
Local Anesthesia
Pain
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Global pain intensity experienced during the procedure.
timeFrame: At the end of surgery
Secondary outcomes:
measure: Need for supplementary sedation and/or analgesia during the procedure.
timeFrame: At the end of surgery
measure: Global anxiety intensity experienced during the procedure.
timeFrame: At the end of surgery
measure: Patient's comfort during the procedure assessed by the surgeon and cardiologist.
timeFrame: At the end of surgery
measure: Incidence of motion sickness during the virtual reality experience.
timeFrame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
measure: Patient's perceived procedure duration.
timeFrame: At the end of surgery
measure: Maximal systolic arterial blood pressure.
timeFrame: At the end of surgery
measure: Incidence of hypotensive or hypoxic events during procedure.
timeFrame: At the end of surgery
measure: Total dose of local anaesthetic used during the procedure.
timeFrame: At the end of surgery
measure: Change in anesthetic strategy during procedure.
timeFrame: At the end of surgery
measure: Interruption of virtual reality experience during the procedure.
timeFrame: At the end of surgery
measure: Intra- and post-procedure complications.
timeFrame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
measure: Overall patient's comfort and satisfaction experienced during the procedure.
timeFrame: At patient discharge (or at a maximum of 4 hours after the end of surgery)
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto CardioCentro
state: Ticino
Study officials:
References: