Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorPether Jildenstal

About this trial

We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

over 65 years, planed surgery in local anesthesia/regional anesthesia

Disqualifiers

dementia, unable to cooperate, cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality

    Device

    Participant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: VR groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

propofol mg/kg

dose of propofol given during surgery to the participant

Time frame
during the surgery (90 minutes max)

Secondary outcomes

1

Surgeons satisfaction

surgeons satisfaction, measured with NASA task load index (tlx). Higher score, worse outcome.

Time frame
Directly after surgery is finished
2

Stress/anxiety

Stress or anxiety felt during surgery by participant, measured with State-Trait Anxiety Inventory (STAI) . Higher score worse outcome.

Time frame
during the surgery (90 minutes max)
3

Nurse anesthetists experience, (questionnaire).

Nurse anesthetists experience will be measured with a questionnaire egarding how well the monitoring of the patient could be carried out and the degree to which the patient was perceived as calm. The higher score, the better.

Time frame
Directly after surgery is finished
4

Level of pain

Patients level of pain after surgery, measured with Numeric rating scale (NRS). The higher scores mean worse outcome.

Time frame
Directly after surgery is finished

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pether Jildenstal

Lead sponsor

Göteborg University

Sponsor institution

Sahlgrenska University Hospital

Collaborator