Clinical trial NCT06649383: Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication
Official title: Virtual Reality for Elderly Patients in Anesthesia and Surgical Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Virtual Reality
Distraction
Elderly (people Aged 65 or More)
Keywords: virtual reality
distraction
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2024-10-18
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:

Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.

Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.

Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.

Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.

We also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward.

The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery.

The primary outcome effect of VR glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* dementia, unable to cooperate, cognitive impairment

Primary outcomes:
measure: propofol mg/kg
timeFrame: during the surgery (90 minutes max)
Secondary outcomes:
measure: Surgeons satisfaction
timeFrame: Directly after surgery is finished
measure: Stress/anxiety
timeFrame: during the surgery (90 minutes max)
measure: Nurse anesthetists experience, (questionnaire).
timeFrame: Directly after surgery is finished
measure: Level of pain
timeFrame: Directly after surgery is finished
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Alingsås lasarett
state: Västra götaland
city: Göteborg
country: Sweden
facility: Sahlgrenska universitetssjukhuset
state: Västra götaland
Study officials:
References: