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

Virtual Reality for Elderly Patients in Anesthesia and Surgical Care

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.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality; Distraction; Elderly (people Aged 65 or More)
• Intervention / Treatment: Device: Virtual reality

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).

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pether Jildenstål, Docent; Phone Number: +46760266658; Email: pether.jildenstal@vgregion.se

Study Locations

• Sweden
  • Västra götaland
    • Alingsås, Västra götaland, Sweden, 441 33
      • Recruiting
      • Alingsas lasarett
      • Contact: Joakim Strömberg, associate professor; Phone Number: 0046313421000; Email: joakim.stromberg@vgregion.se
    • Göteborg, Västra götaland, Sweden, 414 72
      • Recruiting
      • Sahlgrenska Universitetssjukhuset
      • Contact: Kristian Hermander, Nurse anesthetist; Phone Number: +46709374816; Email: kristian.hermander@vgregion.se
      • Contact: Kristian Hermander

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• dementia, unable to cooperate, cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR group; This group use VR glasses during surgery	Device: Virtual reality; 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.
No Intervention: Control group; Control group without intervention, conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
propofol mg/kg	dose of propofol given during surgery to the participant	during the surgery (90 minutes max)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeons satisfaction	surgeons satisfaction, measured with NASA task load index (tlx). Higher score, worse outcome.	Directly after surgery is finished
Stress/anxiety	Stress or anxiety felt during surgery by participant, measured with State-Trait Anxiety Inventory (STAI) . Higher score worse outcome.	during the surgery (90 minutes max)
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.	Directly after surgery is finished
Level of pain	Patients level of pain after surgery, measured with Numeric rating scale (NRS). The higher scores mean worse outcome.	Directly after surgery is finished

Collaborators and Investigators

• Sponsor: Pether Jildenstal
• Collaborators: Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): June 15, 2029

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: virtual reality; distraction
• Other Study ID Numbers: 2023-04059-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No