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

NCT06649383 | Recruiting Phase 4

• 1 other identifier: 2023-04059-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Virtual Reality; Distraction; Elderly (people Aged 65 or More)

Keywords

virtual reality; distraction

Outcome Measures

Primary Outcomes (1)

• propofol mg/kg

  dose of propofol given during surgery to the participant

  during the surgery (90 minutes max)

Secondary Outcomes (4)

• Surgeons satisfaction

  Directly after surgery is finished

• Stress/anxiety

  during the surgery (90 minutes max)

• Nurse anesthetists experience, (questionnaire).

  Directly after surgery is finished

• Level of pain

  Directly after surgery is finished

Study Arms (2)

VR group

EXPERIMENTAL

This group use VR glasses during surgery

Device: Virtual reality

Control group

NO INTERVENTION

Control group without intervention, conventional treatment

Interventions

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.

VR group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• dementia, unable to cooperate, cognitive impairment

Sponsors & Collaborators

• Pether Jildenstal: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (2)

Alingsås lasarett

Alingsås, Västra Götaland County, 441 33, Sweden

RECRUITING

Sahlgrenska universitetssjukhuset

Gothenburg, Västra Götaland County, 414 72, Sweden

RECRUITING

Central Study Contacts

Pether Jildenstål, Docent

CONTACT

+46760266658; pether.jildenstal@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Pether Jildenstal Gothenburg University

Model Details: RCT

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): June 15, 2029
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)